Last updated: 11/28/20

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Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) for the Treatment of Unresectable Hepatocellular Carcinoma That Has Progressed After Prior Systemic Therapy(Exelixis Press Release)
...today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.
Hepatocellular Cancer | cabozantinib tablet
Evidence: A1 - Approval
1 day ago
Guardant Health and Foundation Medicine face off in another legal battle(BioSpace)
"…Guardant Health is taking Roche-owned Foundation Medicine to court over a patent dispute for their liquid biopsy technology, further heating up the rivalry between the two cancer detection companies...In newly released documents, Guardant claims Foundation is currently infringing on up to seven patents which are part of Guardant’s intellectual property for its liquid biopsy test. Guardant and Foundation are key competitors in this field, both using simple blood draw tests to identify DNA shed by a tumor…Guardant’s suit, filed by Weil, Gotshal & Manges LLP and Farnan LLP, claims Foundation’s FoundationOne Liquid product is nearly identical to Guardant’s Guardant360."
Guardant360® / Guardant Health; FoundationOne® Liquid CDx / Roche
Patent
2 days ago
RhoVac’s Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA()
FDA has granted Fast Track Designation to RhoVac’s drug candidate, RV001. The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US.
Prostate Cancer | RV001
Evidence: B - Late Trials
4 days ago
Comparison of three FDA-approved diagnostic immunohistochemistry assays of PD-L1 in triple-negative breast carcinoma.(PubMed)
However, the other two assays were not able to identify all tumors that would test positive with SP142 using IC or TCIC/CPS. It is unlikely to achieve high agreement between SP142 and the other two assays by changing the analytical cutoffs.
PD-L1 IHC 22C3 pharmDx / Agilent Tech; VENTANA PD-L1 (SP142) Assay / Roche; PD-L1 IHC 28-8 pharmDx / Agilent Tech
FDA event | Journal
5 days ago
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(Bristol-Myers Squibb Press Release)
Bristol Myers Squibb today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)...
Esophageal Squamous Cell Carcinoma | nivolumab
Evidence: A1 - Approval
5 days ago
Innovent Releases Phase 3 Results of TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Biosimilar Injection) as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma at ESMO ASIA Virtual Congress 2020(BioSpace)
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announced...The significantly improved OS and PFS benefits brought by TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) over sorafenib were generally consistent across all subgroups. The combination regimen showed an acceptable safety profile with no new safety signals. With these results, TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) could potentially provide a new option for the first-line treatment of patients with advanced HCC.
Hepatocellular Cancer | sintilimab + Byvasda (bevacizumab biosimilar)
Evidence: B - Late Trials
6 days ago
Theralink Technologies announces partnership with Perthera to facilitate and accelerate access to its unique phosphoprotein and drug target activation testing in the U.S.(Theralink Technologies Press Release)
"Theralink Technologies…today announced its partnership with Perthera…The alliance will facilitate and accelerate access to Theralink’s 32 phosphoprotein panel, the Theralink assay, across the U.S. for breast cancer patients…Through this partnership, Perthera will develop and manage Theralink’s observational registry trial, TRACE (Theralink Registry to Assess Comprehensive Effectiveness). Perthera will utilize its Precision Oncology Platform, and serve as a Clinical Research Organization (CRO), to establish and launch the participation of Oncology practices and hospitals in the observational study throughout the US, implement the TRACE protocol, and assist in the enrollment of patients. Theralink will also utilize Perthera’s Therapeutic Intelligence Engine™ to deliver a highly differentiated clinical report for physicians to gain clinical decision support more effectively from the innovative Theralink assay."
Theralink Assay / Theralink
Licensing / partnership
7 days ago
LBA-4 Efficacy and Safety Results from ASCEMBL, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with =2 Tyrosine Kinase Inhibitors (TKIs(ASH 2020)
...At baseline, ≥1 BCR-ABL1 mutation was present in 12.7% pts...asciminib, a first-in-class STAMP inhibitor, demonstrated statistically significant and clinically meaningful superiority in efficacy compared with BOS (primary objective), deeper MR rates, and a favorable safety profile. These results support the use of asciminib as a new treatment option in CML, particularly in R/I pts who received ≥2 prior TKIs.
BCR-ABL1 fusion | Chronic Myeloid Leukemia | ABL001
Evidence: B - Late Trials
9 days ago
ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma(ADC Therapeutics Press Release)
ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status.
Diffuse Large B Cell Lymphoma | loncastuximab tesirine
Evidence: B - Late Trials
9 days ago
NCCN
Bone cancer systemic therapy agents...Pembrolizumab for TMB-H...TMB-H for patients with unresectable or metastatic tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.
TMB-H | Chordoma | pembrolizumab
Evidence: A2 - Guideline
9 days ago
BeiGene Announces the Approval of XGEVA® (Denosumab) in China for the Prevention of Skeletal-Related Events in Patients With Bone Metastases From Solid Tumors and in Patients With Multiple Myeloma(BeiGene Press Release)
BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 19, 2020-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM).
Multiple Myeloma | denosumab
Evidence: A1 - Approval
10 days ago
Nucleix’s BE Safe @Home Project brings bladder cancer surveillance to patients’ homes during COVID-19 pandemic and beyond(Businesswire)
"Nucleix…announced the launch of its BE Safe @Home project to bring surveillance for recurrence of non-muscle invasive bladder cancer (NMIBC) to patients’ homes with its Bladder EpiCheck® urine test. This initiative was developed after consulting with world-leading urologists in an effort to make surveillance more convenient for patients during COVID-19 and beyond. The project is implemented in Israel, Spain and the Netherlands."
Bladder EpiCheck® / Nucleix
Launch
10 days ago
Agendia and Paige announce landmark strategic partnership to revolutionize treatment planning in breast cancer(Agendia Press Release)
"Agendia, Inc…and Paige…today announced a first of its kind strategic partnership that will redefine precision oncology. The partnership will enable co-development of treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia’s proprietary MammaPrint® and BluePrint® diagnostic tests for patients with breast cancer. These new products will enable faster access to predictive and prognostic information along the entire continuum of care, from diagnosis and early intervention to metastatic treatment planning."
BluePrint / Agendia; MammaPrint / Agendia
Licensing / partnership
11 days ago
PTC Therapeutics Announces Key Regulatory Designations for PTC596 to Advance Treatment of Two Rare Oncology Indications(PTC Therapeutics Press Release)
PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both Orphan Drug Designation and Fast Track designation for the potential treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue.
Leiomyosarcoma | PTC596
Evidence: B - Late Trials
11 days ago
Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies(SABCS 2020)
Patients with HER2E (hazard ratio [HR], 0.389; P < .0001), LumB (HR, 0.521; P = .0001), LumA (HR, 0.633; P = .0007), and normal-like (HR, 0.467; P = .0005) subtypes all derived benefit from RIB treatment,...Patients with HER2E, LumA, LumB, and normal-like subtypes all exhibited a consistent PFS benefit with RIB treatment, while patients with basal-like ABC (RIB: 2%; PBO: 3%) did not. The HER2E subtype (RIB: 14%; PBO: 11%) exhibited the greatest relative reduction in risk of progression or death (61%) with RIB plus ET.
ER positive + PGR positive + HER-2 positive | Breast Cancer | ribociclib
Evidence: B - Late Trials
12 days ago
Genomic profiling and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: An exploratory analysis from the phase 3 IMpassion130 tria(SABCS 2020)
...CNA in CDKN2A (12%) and CDKN2B (11%) were associated with improved PFS and OS clinical activity in the A + nP arm vs the P + nP arm (HR PFS, 0.43-0.44 and HR OS, 0.47, respectively).
CDKN2A mutation | Triple Negative Breast Cancer | atezolizumab
Evidence: B - Late Trials
12 days ago
E2112: Randomized phase 3 trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. A trial of the ECOG-ACRIN cancer research group(SABCS 2020)
The combination of exemestane and entinostat did not improve survival in AI resistant advanced HR-positive, HER2-negative breast cancer.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | SNDX-275
Evidence: B - Late Trials
12 days ago
107P - Safety and efficacy of trifluridine/tipiracil (FTD/TPI) in previously treated metastatic colorectal cancer (mCRC): Results from the Australian cohort of the phase IIIb, international, open-label, early-access PRECONNECT study(ESMO Asia 2020)
60% had RAS-mutant cancers...FTD/TPI was associated with a median PFS of 2.7 months (95% CI, 2.4–3.4) and disease control rate of 40% (95% CI, 28.47–52.41)….Results from the Australian cohort are consistent with the global PRECONNECT population and randomised datasets in previously treated mCRC patients.
KRAS mutation | Colorectal Cancer | trifluridine/tipiracil
Evidence: B - Late Trials
12 days ago
Plk1 expression & efficacy of palbociclib in advanced hormonal receptor-positive breast cancer patients from PEARL study (GEICAM 2012-03)(SABCS 2020)
In the whole cohort, pts with high levels (> median) of PLK1 (PLK1-high) treated with PAL, had a worse PFS in a multivariate model (5.7 months (m) vs 9.3 m of median PFS in PLK1-High vs -Low;
PLK1-H | Breast Cancer | palbociclib
Evidence: B - Late Trials
12 days ago
The role of adjuvant targeted therapy for postoperative EGFR mutant non-small cell lung cancer: A network meta-analysis(ESMO Asia 2020)
Osimertinib provided the most DFS benefits and safety profile among the 6 treatments. Considering both efficacy and toxic effect, osimertinib is a promising agent in adjuvant setting for EGFR-mutant NSCLC, especially for those with exon 19 deletion.
EGFR exon 19 deletion | Non Small Cell Lung Cancer | osimertinib
Evidence: B - Late Trials
12 days ago
Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies(SABCS 2020)
Patients with HER2E (hazard ratio [HR], 0.389; P < .0001), LumB (HR, 0.521; P = .0001), LumA (HR, 0.633; P = .0007), and normal-like (HR, 0.467; P = .0005) subtypes all derived benefit from RIB treatment,...Patients with HER2E, LumA, LumB, and normal-like subtypes all exhibited a consistent PFS benefit with RIB treatment, while patients with basal-like ABC (RIB: 2%; PBO: 3%) did not. The HER2E subtype (RIB: 14%; PBO: 11%) exhibited the greatest relative reduction in risk of progression or death (61%) with RIB plus ET.
ER positive + PGR negative + HER-2 negative | Breast Cancer | ribociclib
Evidence: B - Late Trials
12 days ago
Abemaciclib plus fulvestrant in East Asian women with HR+, HER2- advanced breast cancer: Overall survival from MONARCH 2(ESMO Asia 2020)
The OS rates at 42 mo were 64% (95% CI 55.5, 71.8) for abemaciclib + F and 53% (95% CI 39.9, 64.6) for P + F. PFS2 (HR: 0.588 95% CI 0.420, 0.823; p=.001), time to chemotherapy (HR: 0.601 95% CI 0.411, 0.877; p=.008) and chemotherapy-free survival (HR: 0.573 95% CI 0.402, 0.815; p=.002) were all significantly improved in pts treated with abemaciclib + F....abemaciclib + F was an effective and tolerable treatment for East Asian patients with HR+, HER2- ABC who progressed on ET.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | abemaciclib
Evidence: B - Late Trials
12 days ago
Capecitabine maintaining treatment improves progression-free survival in metastatic breast cancer: A prospective observational study of 669 cases(SABCS 2020)
...metastatic breast cancer…Capecitabine maintaining treatment group showed a significant improvement in PFS compared with non-maintaining group [hazard ratio = 0.53 (95% confidence interval = 0.41-0.68); log-rank test p<0.0001]….PIK3CA helical domain mutation (33%) and TP53 mutation (42.9%) concentrated in patients with poor PFS....HR-positive patients benefited more from capecitabine-based chemotherapy...
HR positive | Hormone Receptor Positive Breast Cancer | capecitabine
Evidence: B - Late Trials
12 days ago
378MO - EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) =50%(ESMO Asia 2020)
CO rate to cemiplimab was 73.9%. In the ITT population, cemiplimab was associated with higher response rate (36.5% vs 20.6%), longer median duration of response (21.0 months vs 6.0 months) and lower rates of Grade ≥3 adverse events regardless of attribution (37.2% vs 48.5%) compared to chemo. In this study, 1L cemiplimab monotherapy significantly improved OS and PFS vs chemo in pts with advanced NSCLC with PD-L1 ≥50%, despite high CO rate, providing rationale for cemiplimab as a new treatment option for this patient population.
PD-L1 overexpression | Non Small Cell Lung Cancer | cemiplimab
Evidence: B - Late Trials
12 days ago
Neoadjuvant pyrotinib plus trastuzumab and chemotherapy for stage I-III HER2-positive breast cancer: Results of a single-arm pilot clinical trial(SABCS 2020)
19 eligible patients were administrated pyrotinib neoadjuvant therapy with epirubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab...The tpCR rate was 72.2% (95% CI: 46.5 - 90.3), and no recurrence or metastasis occurred during the short-term follow-up period...The objective response rate (ORR) was 100% (95% CI: 81.5 - 100) at the end of eighth cycle...HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant...
HER-2 positive | HER2 Positive Breast Cancer | trastuzumab + SHR-1258
Evidence: C3 – Early Trials -> B - Late Trials
12 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE3(SABCS 2020)
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)...
BRCA1 mutation | HER2 Negative Breast Cancer | ABT-888
Evidence: B - Late Trials
12 days ago
Pembrolizumab versus chemotherapy for previously treated metastatic triple-negative breast cancer (KEYNOTE-119): Efficacy in patients with lung or liver metastases(SABCS 2020)
...pembrolizumab (pembro) monotherapy vs single-agent chemotherapy (chemo) in patients with previously treated metastatic triple-negative breast cancer (mTNBC)...with the greatest benefit observed in patients with PD-L1 CPS ≥20 tumors...pembro monotherapy showed a benefit vs single-agent chemo in patients with increasing PD-L1 tumor enrichment...
PD-L1 overexpression | Triple Negative Breast Cancer | pembrolizumab
Evidence: C3 – Early Trials -> B - Late Trials
12 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE6(SABCS 2020)
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)...
BRCA2 mutation | HER2 Negative Breast Cancer | ABT-888
Evidence: B - Late Trials
12 days ago
Capecitabine maintaining treatment improves progression-free survival in metastatic breast cancer: A prospective observational study of 669 cases(SABCS 2020)
...metastatic breast cancer…Capecitabine maintaining treatment group showed a significant improvement in PFS compared with non-maintaining group [hazard ratio = 0.53 (95% confidence interval = 0.41-0.68); log-rank test p<0.0001]….PIK3CA helical domain mutation (33%) and TP53 mutation (42.9%) concentrated in patients with poor PFS....HR-positive patients benefited more from capecitabine-based chemotherapy...
TP53 mutation | Hormone Receptor Positive Breast Cancer | capecitabine
Evidence: B - Late Trials
12 days ago
BeiGene Announces that RATIONALE 303 Trial of Tislelizumab in Non-Small Cell Lung Cancer Met the Primary Endpoint of Overall Survival at Interim Analysis(BeiGene Press Release)
BeiGene, Ltd....today announced that the RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)...The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression...met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) patient population at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC).
PD-L1 overexpression | Non Small Cell Lung Cancer | tislelizumab
Evidence: C3 – Early Trials -> B - Late Trials
12 days ago
"Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib"(SABCS 2020)
"These updated results with extended follow-up demonstrated an OS benefit with RIB + ET vs PBO + ET (median, 58.7 vs 48.0 mo; HR, 0.76 [95% CI, 0.61-0.96]). In patients receiving an NSAI, a similar OS benefit was observed with RIB + NSAI vs PBO + NSAI (median, 58.7 vs 47.7 mo; HR, 0.80 [95% CI, 0.62-1.04])."
HR positive | HER2 Negative Breast Cancer | ribociclib + letrozole
Evidence: C3 – Early Trials -> B - Late Trials
12 days ago
107P - Safety and efficacy of trifluridine/tipiracil (FTD/TPI) in previously treated metastatic colorectal cancer (mCRC): Results from the Australian cohort of the phase IIIb, international, open-label, early-access PRECONNECT study(ESMO Asia 2020)
60% had...10% had BRAF-(V600E) mutant cancers...FTD/TPI was associated with a median PFS of 2.7 months (95% CI, 2.4–3.4) and disease control rate of 40% (95% CI, 28.47–52.41)….Results from the Australian cohort are consistent with the global PRECONNECT population and randomised datasets in previously treated mCRC patients.
BRAF V600E | Colorectal Cancer | trifluridine/tipiracil
Evidence: B - Late Trials
12 days ago
"Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib"()
"These updated results with extended follow-up demonstrated an OS benefit with RIB + ET vs PBO + ET (median, 58.7 vs 48.0 mo; HR, 0.76 [95% CI, 0.61-0.96]). In patients receiving an NSAI, a similar OS benefit was observed with RIB + NSAI vs PBO + NSAI (median, 58.7 vs 47.7 mo; HR, 0.80 [95% CI, 0.62-1.04])."
HR positive | HER2 Negative Breast Cancer | ribociclib + anastrozole
Evidence: B - Late Trials
12 days ago
Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane(SABCS 2020)
CONTESSA, which enrolled 685 patients, met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for capecitabine alone, an improvement of 2.9 months [HR=0.716 (95% CI: 0.573- 0.895); p=0.003]. ORR was 57% for tesetaxel plus a reduced dose of capecitabine versus 41% for capecitabine alone (p=0.0002). OS data are immature. Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with previous clinical studies....An all-oral regimen of tesetaxel plus a reduced dose of capecitabine significantly improved PFS versus capecitabine alone.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | capecitabine
Evidence: B - Late Trials
12 days ago
Ribociclib + letrozole in male patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC): Subgroup analysis of the phase IIIb CompLEEment-1 trial(SABCS 2020)
Pts received RIB (600 mg QD, 3 weeks on/1 week off) in combination with LET (2.5 mg QD, continuous). For the 32 patients with measurable disease, ORR was 46.9% (95% CI, 29.1-65.3%) and CBR was 71.9% (95% CI, 53.3-86.3)...efficacy results support the use of RIB + LET in HR+, HER2- ABC in a close to real-world setting.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | ribociclib
Evidence: B - Late Trials
12 days ago
ER positive + HER-2 negative | HER2 Negative Breast Cancer | palbociclib
Evidence: B - Late Trials
12 days ago
Neoadjuvant adriamycin plus cyclophosphamide followed by docetaxel (AC4-D4) vs 5-fluorouracil, epirubicin plus cyclophosphamide followed by docetaxel (FEC3-D3) in stage II or III operable breast cancer : Randomized phase III neo-shorter trial (NCT02001506)(SABCS 2020)
Neoadjuvant adriamycin plus cyclophosphamide followed by docetaxel (AC4-D4) vs 5-fluorouracil, epirubicin plus cyclophosphamide followed by docetaxel (FEC3-D3) in stage II or III operable breast cancer...in AC4-D4 arm, 95/103 pts achieved clinical response (6 complete response [CR] and 89 partial response [PR]) and among them 18 pts (17.5%) achieved pCR. In FEC3-D3 arm, 97/119 pts achieved clinical response (4 CR and 93 PR) and among them 15 pts (12.6%) achieved pCR.
Breast Cancer | docetaxel + doxorubicin hydrochloride + cyclophosphamide intravenous
Evidence: B - Late Trials
12 days ago
Genomic profiling and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: An exploratory analysis from the phase 3 IMpassion130 trial(SABCS 2020)
...CNA in CDKN2A (12%) and CDKN2B (11%) were associated with improved PFS and OS clinical activity in the A + nP arm vs the P + nP arm (HR PFS, 0.43-0.44 and HR OS, 0.47, respectively).
CDKN2B mutation | Triple Negative Breast Cancer | atezolizumab
Evidence: B - Late Trials
12 days ago
Myriad Genetics Announces Global Expansion of Myriad myChoice Tumor Testing in Europe and China(GlobeNewswire)
"Myriad Genetics, Inc…announced today the expansion of Myriad myChoice® tumor testing in several European markets and China…As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the company’s global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriad’s myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC)...Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology."
Myriad myChoice® CDx / Myriad Genetics
Clinical | Licensing / partnership
13 days ago
Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100(J Clin Oncol)
NON-SUPPORTIVE EVIDENCE: JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.
Gastroesophageal Junction Adenocarcinoma | avelumab
Evidence: C3 – Early Trials -> B - Late Trials
13 days ago
Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100(J Clin Oncol)
NON-SUPPORTIVE SENSITIVE EVIDENCE: JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.
Gastric Cancer | avelumab
Evidence: C3 – Early Trials -> B - Late Trials
13 days ago
Clinical Genomics announces Medicare coverage applicable to COLVERA®(Clinical Genomics Press Release)
"Clinical Genomics…today announced that Novitas Solutions…updated its Local Coverage Determination applicable to biomarkers in oncology, including COLVERA...Novitas updated the Local Coverage Determination (‘LCD’): Biomarkers for Oncology (L35396) to allow Medicare coverage for COLVERA for medically necessary tests performed on or after July 1, 2020. This determination applies to patients across the United States covered by the Centers for Medicare and Medicaid Services (‘CMS’) whose claims for testing are submitted by Clinical Genomics in New Jersey. Medicare beneficiaries currently account for more than 50% of the COLVERA tests ordered by physicians and other licensed clinicians. Subsequent to the publication of the updated coverage determination, Clinical Genomics has received payment for numerous COLVERA tests that meet appropriate use criteria."
COLVERA™ / Clinical Genomics
Reimbursement
14 days ago
Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial(The Lancet)
Median progression-free survival was 13·93 months (95% CI 11·73–not evaluable) with selinexor, bortezomib, and dexamethasone and 9·46 months (8·11–10·78) with bortezomib and dexamethasone (hazard ratio 0·70 [95% CI 0·53–0·93], p=0·0075)….A once-per-week regimen of selinexor, bortezomib, and dexamethasone is a novel, effective, and convenient treatment option for patients with multiple myeloma.
Multiple Myeloma | bortezomib + selinexor
Evidence: B - Late Trials
15 days ago
Agilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer(Businesswire)
"Agilent Technologies...announced it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA® (pembrolizumab)...PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA."
pembrolizumab
PD-L1 IHC 22C3 pharmDx / Agilent Tech
FDA event
15 days ago
NeoGenomics to offer mobile phlebotomy services for liquid biopsy tests(NeoGenomics Press Release)
"NeoGenomics...announced today the launch of a mobile phlebotomy service for its blood-based tests, including InVisionFirst®-Lung, its advanced non-small cell lung cancer liquid biopsy test, and the NeoLAB® liquid biopsy suite of tests encompassing solid tumor and hematologic cancers...NeoGenomics will arrange for the blood sample collection at the patient's desired location and cover the expense of the mobile phlebotomy blood service."
InVisionFirst®-Lung / Inivata; NeoLAB® Solid Tumor Liquid Biopsy / NeoGenomics
Launch
15 days ago
The role of amplified in breast cancer 1 in breast cancer: A meta-analysis(Medicine (Baltimore))
Nine eligible studies, including 6774 patients, were finally assessed by the current clinical meta-analysis...This analysis demonstrated that AIB1 overexpression is related to aggressive phenotypes and unfavorable clinical outcomes in BC, and might involve in tamoxifen resistance. AIB1 may be a new prognostic biomarker and therapeutic target in BC.
ANIB1 overexpression | Breast Cancer | tamoxifen
Evidence: B - Late Trials
16 days ago
FDA
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...Triple-Negative Breast Cancer (TNBC)...in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA approved test.
PD-L1 expression | Triple Negative Breast Cancer | pembrolizumab
Evidence: B - Late Trials -> A1 - Approval
16 days ago
Adaptive Biotechnologies announces collaboration with GSK to measure minimal residual disease with clonoSEQ® assay across its hematology and oncology portfolio(Adaptive Biotechnologies Press Release)
"Adaptive Biotechnologies Corporation…today announced a collaboration with GlaxoSmithKline plc (GSK) to use its clonoSEQ® Assay to assess minimal residual disease (MRD) in GSK’s portfolio of hematology products...As part of the non-exclusive, pan-portfolio translational collaboration, Adaptive’s clonoSEQ Assay also may be used in GSK hematology clinical trials to generate data supporting the clinical value of monitoring MRD in the context of patient care."
clonoSEQ / Adaptive Biotech
Licensing / partnership
17 days ago
Deciphera Presents Data from QINLOCK (Ripretinib) Program at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting(Deciphera Pharmaceuticals)
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study...QINLOCK demonstrated clinically meaningful activity in patients with fourth-line and fourth-line plus GIST (n=129) with multiple, heterogeneous genetic subsets of KIT/PDGFRA mutations. QINLOCK showed a median progression free survival (PFS) benefit of 6.3 months...
PDGFRA mutation | Gastrointestinal Stromal Tumor | ripretinib
Evidence: C3 – Early Trials -> B - Late Trials
18 days ago
Deciphera Presents Data from QINLOCK (Ripretinib) Program at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting(Deciphera Pharmaceuticals)
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study...QINLOCK demonstrated clinically meaningful activity in patients with fourth-line and fourth-line plus GIST (n=129) with multiple, heterogeneous genetic subsets of KIT/PDGFRA mutations. QINLOCK showed a median progression free survival (PFS) benefit of 6.3 months...
KIT mutation | Gastrointestinal Stromal Tumor | ripretinib
Evidence: C3 – Early Trials -> B - Late Trials
18 days ago
Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer(Surface Oncology Press Release)
Surface Oncology...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer, who have been previously treated with standard therapies, such as vascular endothelial growth factor targeted agents and programmed death-ligand (PD-L1) blockade.
Hepatocellular Cancer | SRF388
Evidence: B - Late Trials
18 days ago
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients…(Merck (MSD) Press Release)
KEYTRUDA plus LENVIMA met the trial’s primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population.
Renal Cell Carcinoma | pembrolizumab + lenvatinib
Evidence: B - Late Trials
19 days ago
Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer(GlobeNewswire)
...Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead compound, CPI-613® (devimistat), for the treatment of metastatic pancreatic cancer.
Pancreatic Cancer | devimistat
Evidence: B - Late Trials
19 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has also recommended venetoclax plus obinutuzumab as a new treatment option via the Cancer Drugs Fund, for people with untreated CLL without a 17p deletion or TP53 mutation for whom FCR or BR is suitable.
Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
19 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has...recommended a new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia (CLL)...Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation).
Chr del(17p) | Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
19 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has...recommended a new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukemia (CLL)...Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation).
TP53 mutation | Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
19 days ago
FDA
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated...for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed followin concurrent platinum-based chemotherapy and radiation therapy.
Non Small Cell Lung Cancer | durvalumab
Evidence: A2 - Guideline -> A1 - Approval
19 days ago
FDA
LENVIMA is a kinase inhibitor that is indicated...In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy.
Renal Cell Carcinoma | lenvatinib
Evidence: A2 - Guideline -> A1 - Approval
19 days ago
FDA
LENVIMA is a kinase inhibitor that is indicated...For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Thyroid Gland Carcinoma | lenvatinib
Evidence: B - Late Trials -> A1 - Approval
19 days ago
EarlyCDT-Lung patent expiry: 2027 in US(N+1 Singer)
A subscription to Thomson ONE is required to gain full access to report 70739637; Page no: 2; REPORT TITLE: "Oncimmune Holdings Plc- Initiating coverage- N+1 Singer - Oncimmune Holdings - A growth platform - Initiation and FY20 results"; AUTHOR: Thomason, Edward, et al; DATE: 10/30/2020
EarlyCDT®-Lung / Oncimmune
Patent
19 days ago
Foundation Medicine Expands Indication for FoundationOne Liquid CDx to be used as a Companion Diagnostic for LYNPARZA(Businesswire)
“Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for LYNPARZA® (olaparib). As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with LYNPARZA.”
olaparib
FoundationOne® Liquid CDx / Roche
FDA event
20 days ago
266 Tumour mutation burden (TMB) and efficacy outcomes in the phase III DANUBE study of advanced urothelial carcinoma (UC)(SITC 2020)
The phase III DANUBE study assessed the efficacy of the PD-L1 inhibitor durvalumab (D), alone or in combination with the CTLA-4 inhibitor tremelimumab (T), versus standard of care chemotherapy (SoC) for the first-line treatment of unresectable, locally advanced or metastatic UC. Among 1032 patients randomised in DANUBE...For D vs SoC, bTMB and tTMB were not associated with OS or PFS at any cutoff. For D+T, stronger associations between bTMB and OS as well as PFS were observed with increasing bTMB cutoffs (table 1). At the bTMB cutoff ≥ 24 mut/Mb, 12-month OS rates were 76.7% for D+T and 54.3% for SoC, whereas for bTMB < 24 mut/Mb, 12-month OS rates were 53.4% for D+T and 51.2% for SoC. Similar trends for both OS and PFS were observed with tTMB. Both bTMB and tTMB are potentially useful biomarkers for enriching responses to D+T in previously untreated, advanced UC. Neither bTMB nor tTMB was associated with better outcomes for D monotherapy.
TMB-H | Urothelial Cancer | durvalumab + CP-675206
Evidence: C3 – Early Trials -> B - Late Trials
20 days ago
266 Tumour mutation burden (TMB) and efficacy outcomes in the phase III DANUBE study of advanced urothelial carcinoma (UC)(SITC 2020)
The phase III DANUBE study assessed the efficacy of the PD-L1 inhibitor durvalumab (D), alone or in combination with the CTLA-4 inhibitor tremelimumab (T), versus standard of care chemotherapy (SoC) for the first-line treatment of unresectable, locally advanced or metastatic UC. Among 1032 patients randomised in DANUBE...For D vs SoC, bTMB and tTMB were not associated with OS or PFS at any cutoff. For D+T, stronger associations between bTMB and OS as well as PFS were observed with increasing bTMB cutoffs (table 1). At the bTMB cutoff ≥ 24 mut/Mb, 12-month OS rates were 76.7% for D+T and 54.3% for SoC, whereas for bTMB < 24 mut/Mb, 12-month OS rates were 53.4% for D+T and 51.2% for SoC. Similar trends for both OS and PFS were observed with tTMB. Both bTMB and tTMB are potentially useful biomarkers for enriching responses to D+T in previously untreated, advanced UC. Neither bTMB nor tTMB was associated with better outcomes for D monotherapy.
TMB-H | Urothelial Cancer | durvalumab
Evidence: B - Late Trials
20 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
The phase 3 IMspire150 study (NCT02908672) showed that first-line atezolizumab (A) combined with vemurafenib (V) + cobimetinib (C) improved progression-free survival (PFS) vs placebo (P) + V + C in patients with BRAFV600 mutation–positive advanced melanoma...The magnitude of the PFS benefit with A+V+C was further enhanced in patients with high TMB and PD-L1– compared with patients with high TMB and PD-L1+.
TMB-H + PD-L1 negative | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
20 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
...the magnitude of the PFS benefit with A+V+C vs P+V+C was markedly higher in patients with high TMB (≥10 mutations/Mb) compared with patients with low TMB (<10 mutations/Mb) in whom the benefit between treatment arms was comparable...
TMB-H | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
20 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
514 patients were randomized 1:1 to A+V+C (n=256) or P+V+C (n=258)….The PFS and DOR benefits were more evident in patients with high IFN-gamma or TMB >10 mutations/Mb.
IFNG-H | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
20 days ago
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia(AstraZeneca Press Release)
AstraZeneca’s Calquence (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
Chronic Lymphocytic Leukemia | acalabrutinib
Evidence: A1 - Approval
20 days ago
Comparison of three scoring methods using the FDA-approved 22C3 immunohistochemistry assay to evaluate PD-L1 expression in breast cancer and their association with clinicopathologic factors.(PubMed)
Our findings indicate that the three scoring methods with a 1% cutoff are different in their sensitivity for PD-L1 expression and their associations with clinicopathologic factors. Scoring by TCIC is the most sensitive way to identify PD-L1-positive breast cancer by immunohistochemistry. As a prognostic marker, our study suggests that PD-L1 is associated with worse clinical outcome, most often shown by the IC score; however, the other scores may also have clinical implications in some subgroups. Large clinical trials are needed to test the similarities and differences of these scoring methods for their predictive values in anti-PD-1/PD-L1 therapy.
PD-L1 expression | Breast Cancer + Triple Negative Breast Cancer + Solid Tumor
PD-L1 IHC 22C3 pharmDx / Agilent Tech
Clinical | FDA event | Journal
22 days ago
miR Scientific and Puerto Rico Government announce pioneering cooperation agreement to evaluate impact and deployment of its prostate cancer liquid biopsy test in Puerto Rico(PRNewswire)
"miR Scientific, LLC…and the Puerto Rico Health Insurance Administration ('ASES') announced today the signing of a cooperation agreement aimed at evaluating the clinical and economic utility of the miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) and its potential impact in Puerto Rico…The agreement memorializes the explicit intent of deploying the Company's Sentinel™ Prostate Test commercially in Puerto Rico in an effort to alleviate the disease burden of prostate cancer on the Island."
Sentinel Prostate Test™ / miR Scientific
Licensing / partnership
23 days ago
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer(Bristol-Myers Squibb Press Release)
...Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
Non Small Cell Lung Cancer | nivolumab + ipilimumab
Evidence: A1 - Approval
23 days ago
Astellas: XTANDI Approved In China To Treat Non-Metastatic Castration-Resistant Prostate Cancer(Astellas Press Release)
Japan-based Astellas Pharma Inc. (ALPMY) announced Friday that the China National Medical Products Administration or NMPA has approved XTANDI (enzalutamide soft capsules) to treat non-metastatic castration-resistant prostate cancer.
Prostate Cancer | enzalutamide
Evidence: A1 - Approval
23 days ago
Prosigna Breast Cancer Assay now approved for reimbursement in Germany(Veracyte Press Release)
"Veracyte, Inc…has approved its Prosigna® Breast Cancer Gene Signature Assay. The G-BA decision to reimburse the Prosigna test will provide access to the test for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer."
Prosigna™ Breast Cancer Prognostic Gene Signature Assay / NanoString Technologies
Reimbursement
23 days ago
NCCN
THIRD-LINE CHEMOTHERAPY REGIMENS FOR METASTATIC GERM CELL TUMORS...High Dose Chemotherapy NOT Previously Received...Useful in Certain Circumstances...Pembrolizumab (for MSI-H/dMMR or TMB-H tumors)
TMB-H | Germ Cell Tumors | pembrolizumab
Evidence: A2 - Guideline
24 days ago
Lynparza approved in the EU for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
BRCA2 mutation | Prostate Cancer | olaparib
Evidence: A1 - Approval
24 days ago
European Medicines Agency
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Chronic Lymphocytic Leukemia | obinutuzumab + acalabrutinib
Evidence: A2 - Guideline -> A1 - Approval
24 days ago
Lynparza approved in the EU for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
BRCA1 mutation | Prostate Cancer | olaparib
Evidence: A1 - Approval
24 days ago
Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.
HRD | Ovarian Cancer | olaparib + bevacizumab
Evidence: A1 - Approval
24 days ago
Outcomes of First-Line Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE)(ASH 2020)
At 42 mo, PFS rates were significantly higher across high-risk genomic subgroups in ibr-treated pts (63-82%) compared with clb-treated pts (6-34%), and consistent PFS benefit with ibr was observed across all high-risk genomic subgroups....Improved outcome was also noted for pts with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category per Rossi 2013 (HR 1.05, 95% CI 0.54-2.04).
BIRC3 mutation | Chronic Lymphocytic Leukemia | ibrutinib
Evidence: B - Late Trials
25 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
VEGFA mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
Five-Year Analysis of Murano Study Demonstrates Enduring Undetectable Minimal Residual Disease (uMRD) in a Subset of Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients (Pts) Following Fixed-Duration Venetoclax-Rituximab (VenR) Therapy (Tx)(ASH 2020)
In the VenR cohort, uMRD at EOT is associated with improved OS. Unmutated IGVH, del(17p) and GC (≥3 CNV) are associated with higher rates of MRD conversion and subsequent PD after attaining uMRD at EOT. Overall, a substantial proportion of pts who completed Ven Tx retained uMRD 36 mo after treatment cessation, displaying durable response following 2-yr fixed-duration VenR.
Chr del(17p) | Chronic Lymphocytic Leukemia | venetoclax + rituximab
Evidence: B - Late Trials
25 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...However, AA pts harboring FLT3-ITD or IDH2 mutations had shorter OS compared with wild-type pts (FLT3-ITD, HR=1.95, P=.03; IDH2, HR=2.17, P=.008).
FLT3-ITD mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: C3 – Early Trials -> B - Late Trials
25 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...However, AA pts harboring FLT3-ITD or IDH2 mutations had shorter OS compared with wild-type pts (FLT3-ITD, HR=1.95, P=.03; IDH2, HR=2.17, P=.008).
IDH2 mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: B - Late Trials
25 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...Lastly, we performed uni- and multivariable outcome analyses for OS in our Alliance pts. Remarkably, being NPM1-mutated and not being AA were the only positive prognostic factors associated with longer OS in the final risk model (NPM1 mut vs wt, HR=0.72, P<.001; Caucasian vs AA, HR=0.72, P=.03).
NPM1 mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: B - Late Trials
25 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
ABCB1 mutation + VEGFA mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
461 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations(ASH 2020)
IDH1/2 mut pts achieved higher CR+CRh rates with Ven+Aza treatment as compared to pts with IDH not detected (72%/60%)....Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2 mut ineligible for intensive chemotherapy.
IDH1 mutation | Acute Myelogenous Leukemia | venetoclax
Evidence: B - Late Trials
25 days ago
Outcomes of First-Line Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE)(ASH 2020)
At 42 mo, PFS rates were significantly higher across high-risk genomic subgroups in ibr-treated pts (63-82%) compared with clb-treated pts (6-34%), and consistent PFS benefit with ibr was observed across all high-risk genomic subgroups....Improved outcome was also noted for pts with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category per Rossi 2013 (HR 1.05, 95% CI 0.54-2.04).
BIRC3 mutation | Small Lymphocytic Lymphoma | ibrutinib
Evidence: B - Late Trials
25 days ago
461 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations(ASH 2020)
IDH1/2 mut pts achieved higher CR+CRh rates with Ven+Aza treatment as compared to pts with IDH not detected (72%/60%)....Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2 mut ineligible for intensive chemotherapy.
IDH2 mutation | Acute Myelogenous Leukemia | venetoclax
Evidence: B - Late Trials
25 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
ABCB1 mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK positive | Non-Hodgkin’s Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
25 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK negative | Non-Hodgkin’s Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
25 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
LDH elevation | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
MYC rearrangement | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK negative | T Cell Non-Hodgkin Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
25 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
MYC rearrangement + BCL2 rearrangement | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
25 days ago
Strata Oncology announces Medicare Coverage of StrataNGS Comprehensive Genomic Profiling Test for patients with advanced solid tumors(Strata Oncology Press Release)
"Strata Oncology, Inc…announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has established coverage of the StrataNGSTM test for patients with advanced stages (III or IV), recurrent, relapsed, refractory, and/ or metastatic solid tumors."
StrataNGS™ Test / Strata Oncology
Reimbursement
27 days ago
European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer(Roche Press Release)
Roche today announced that the European Commission has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Hepatocellular Cancer | bevacizumab + atezolizumab
Evidence: A1 - Approval
27 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
The standard of care for ChT is cisplatin at a dose of 100 mg/m2 given on days 1, 22 and 43 of concomitant RT (70 Gy) [II, A].
Squamous Cell Carcinoma of Head and Neck | cisplatin
Evidence: A2 - Guideline
28 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
Platinum/5-FU/cetuximab remains the standard therapy for recurrent/metastatic patients with SCCHN not expressing PD-L1 [I, A; ESMO-MCBS v1.1 score: 3]. TPeX is also a treatment option in this population [II, B].
Squamous Cell Carcinoma of Head and Neck | cetuximab
Evidence: A2 - Guideline
28 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
Platinum/5-FU/cetuximab remains the standard therapy for recurrent/metastatic patients with SCCHN not expressing PD-L1 [I, A; ESMO-MCBS v1.1 score: 3]. TPeX is also a treatment option in this population [II, B].
Squamous Cell Carcinoma of Head and Neck | 5-fluorouracil
Evidence: A2 - Guideline
28 days ago
Inivata announces collaboration with Maverick Therapeutics for use of RaDaR™ Assay(Inivata Press Release)
"Inivata…today announces a collaboration with Maverick Therapeutics (‘Maverick’) for the use of Inivata’s RaDaR™ assay for the detection and monitoring of residual disease and recurrence. RaDaR will be used to monitor circulating tumor DNA (ctDNA) in patients enrolled in the Phase 1/2 study of MVC-101, Maverick’s lead program candidate."
RaDaR™ assay / Inivata
Licensing / partnership
29 days ago
Epic Sciences and Predicine jointly announce strategic partnership to expand liquid biopsy offerings to biopharmaceutical partners(Epic Sciences Press Release)
"Epic Sciences, Inc. and Predicine, Inc. today announced they have entered into a global strategic partnership to offer biopharmaceutical companies access to both Predicine’s ctDNA-based testing and Epic’s CTC-based testing. Predicine’s lead offering is PredicineATLASÔ, the broadest CLIA-certified ctDNA-based assay that analyzes 600 cancer-related genes, using next generation sequencing. Epic’s CTC-based platform offers testing of AR-V7, AR-N term, PSMA, ER, PR and other phenotypic tests. The combination of both approaches allows pharmaceutical partners engaged in clinical trials to measure both genotypic and phenotypic markers from a single blood draw."
Oncotype DX AR-V7 Nucleus Detect® test / Epic Sciences; PredicineATLAS™ / Predicine
Licensing / partnership
29 days ago
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer(PRNewswire)
"Roche...today announced U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas® EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy."
cobas® EGFR Mutation Test v2 / Roche
FDA event
30 days ago