While crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1+) non-small-cell lung cancer (NSCLC), unmet needs remain. Taltrectinib has the potential to improve PFS based on its greater potency against ROS1+ tumors and high CNS penetration. By selectively inhibiting ROS1 wild-type and its resistant mutations over TRKB, taltrectinib has a better safety profile with minimal CNS-related AEs compared to other ROS1+ inhibitors.

4 months ago

P1 data • Review • Journal

ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)

ROS1 fusion • ROS1 positive • ROS1 wild-type

Xalkori (crizotinib) • Rozlytrek (entrectinib) • taletrectinib (AB-106)

4ms

Selective TrkA Inhibitor VMD-928 to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma (clinicaltrials.gov)

P1, N=74, Recruiting, VM Oncology, LLC | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025

4 months ago

Trial completion date • Trial primary completion date

NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)

NTRK1 fusion • NTRK1 mutation • NTRK expression

VMD-928

5ms

AnHeart Therapeutics and Foundation Medicine Announce Collaboration to Develop Tissue-Based and Liquid-Based Companion Diagnostics for Taletrectinib, a ROS1 Inhibitor (Businesswire)

"AnHeart Therapeutics...and Foundation Medicine, Inc., today announced the companies have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue-based and liquid-based comprehensive genomic profiling tests, FoundationOne^®CDx and FoundationOne^®Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States....Taletrectinib is a potential best-in-class ROS1 inhibitor being evaluated for the treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), an underserved group of lung cancer patients in need of new options."

5 months ago

Licensing / partnership

FoundationOne® CDx • FoundationOne® Liquid CDx

taletrectinib (AB-106)

7ms

TRUST: A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene (clinicaltrials.gov)

P2, N=173, Active, not recruiting, AnHeart Therapeutics Inc. | Recruiting --> Active, not recruiting | N=106 --> 173

7 months ago

Enrollment closed • Enrollment change • Metastases

ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

ROS1 fusion

taletrectinib (AB-106)

7ms

Comprehensive analysis of cuproptosis genes and cuproptosis-related genes as prognosis factors in esophageal squamous cell carcinoma. (PubMed, Genomics)

The results also showed that milciclib might inhibit the proliferation and migration of KYSE150 and KYSE510 cells by targeting CDKN2A. In conclusion, the abovementioned CUGs and CRGs play a crucial role in tumorigenesis and cancer progression in ESCC, indicating their potential as therapeutic targets.

7 months ago

Journal

CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • BTLA (B And T Lymphocyte Associated) • DLAT (Dihydrolipoamide S-Acetyltransferase) • MELTF (Melanotransferrin) • PRRX1 (Paired Related Homeobox 1) • FDX1 (Ferredoxin 1) • LIAS (Lipoic Acid Synthetase) • LIPT1 (Lipoyltransferase 1) • PDHA1 (Pyruvate Dehydrogenase E1 Subunit Alpha 1)

milciclib (TZLS-201)

10ms

Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study (ESMO 2023)

No treatment-related AE (TRAE) led to discontinuation or death; 24% of pts had a TRAE leading to dose reduction. Conclusions In this ongoing global pivotal phase 2 study, taletrectinib demonstrated robust and consistent clinical activity with TRUST-I, including high response rates and a tolerable safety profile in both TKI-naive and TKI-pretreated pts with ROS1+ NSCLC.

10 months ago

Clinical

ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)

ROS1 G2032R

taletrectinib (AB-106)

1year

Selective TrkA Inhibitor VMD-928 to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma (clinicaltrials.gov)

P1, N=74, Recruiting, VM Oncology, LLC | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

1 year ago

Trial completion date • Trial primary completion date

NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)

NTRK1 fusion • NTRK1 mutation • NTRK expression

VMD-928

1year

TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors. (PubMed, Future Oncol)

Crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1) non-small-cell lung cancer. Secondary end points include duration of response, progression-free survival, overall survival and safety. This trial is enrolling patients in North America, Europe and Asia.

1 year ago

P2 data • Review • Journal

ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

ROS1 fusion • ROS1 positive

Xalkori (crizotinib) • Rozlytrek (entrectinib) • taletrectinib (AB-106)

1year

REGISTRI: Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST (clinicaltrials.gov)

P2, N=15, Completed, Grupo Espanol de Investigacion en Sarcomas | Recruiting --> Completed | N=39 --> 15

1 year ago

Trial completion • Enrollment change • Metastases

KIT (KIT proto-oncogene, receptor tyrosine kinase)

KIT mutation • KIT exon 11 mutation • KIT exon 13 mutation • KIT exon 17 mutation • KIT wild-type • PDGFR wild-type

Stivarga (regorafenib)

1year

STREAM: Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer (clinicaltrials.gov)

P2, N=46, Active, not recruiting, National Cancer Institute, Naples | Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2024

1 year ago

Trial completion date • Trial primary completion date • Metastases

RAS (Rat Sarcoma Virus)

RAS mutation

Stivarga (regorafenib)

1year

Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=28, Recruiting, Sun Yat-sen University | Unknown status --> Recruiting | N=43 --> 28 | Trial completion date: Jul 2020 --> Jul 2023 | Trial primary completion date: Jul 2020 --> Feb 2023

1 year ago

Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases

KRAS (KRAS proto-oncogene GTPase)

KRAS wild-type • RAS wild-type

Stivarga (regorafenib)

1year

An Exploration of Trifluridine/Tipiracil Monotherapy and in Combination With Bevacizumab or Immune Checkpoint Inhibitors for Patients With Metastatic Colorectal Cancer: A Real-World Study. (PubMed, Clin Colorectal Cancer)

In real-world clinical setting, TAS-102 showed consistent clinical efficacy and manageable safety with previous prospective clinical studies. Compared with monotherapy and TAS-102 plus ICIs, TAS-102 plus bevacizumab demonstrated better clinical efficacy for metastatic colorectal cancer.

1 year ago

Journal • Combination therapy • Checkpoint inhibition • Real-world evidence • Real-world • Metastases

KRAS (KRAS proto-oncogene GTPase)

Avastin (bevacizumab) • Stivarga (regorafenib) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)

1year

Circulating Tumor DNA Dynamics and Treatment Outcome of Regorafenib in Metastatic Colorectal Cancer. (PubMed, Cancer Res Treat)

VAF of the majority of the ctDNA mutations increased at the time of disease progression, and VAF of BRAF increased markedly. Reduction in ctDNA burden as estimated by sum (VAF) could be used to predict treatment outcome of regorafenib.

1 year ago

Journal • Circulating tumor DNA • Metastases

BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TCF7L2 (Transcription Factor 7 Like 2)

TP53 mutation

Stivarga (regorafenib)

1year

Is neutrophil-to-lymphocyte ratio and C-reactive protein the prognostic role in metastatic colorectal cancer using regorafenib? (PubMed, J Gastrointest Oncol)

No abstract available

1 year ago

Journal • Metastases

CRP (C-reactive protein)

Stivarga (regorafenib)

1year

Using a combination of fruquintinib, raltitrexed, and S-1 as a third-line treatment for metastatic colorectal cancer with co-existence of Hodgkin lymphoma: a case report. (PubMed, J Gastrointest Oncol)

Fruquintinib, regorafenib, trifluridine/tipiracil (TAS-102), panitumumab and cetuximab combined with single-agent chemotherapy regimens are currently recommended as third-line therapies for patients exhibiting disease progression...The mFOLFOX6 regimen was administered...Liver metastases (intestinal-type adenocarcinoma) were detected in November 2018, and second-line therapy with the FOLFIRI regimen was initiated in January 2019...Third-line therapy with fruquintinib, raltitrexed, and S-1 achieved a PR that permitted surgical resection and enabled a relatively long progression-free survival. The findings suggest that the three agents regimen might be clinically effective as late-line therapy for mCRC.

1 year ago

Clinical • Journal • Metastases

PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)

PIK3CA mutation • RAS wild-type

Erbitux (cetuximab) • 5-fluorouracil • Vectibix (panitumumab) • Stivarga (regorafenib) • oxaliplatin • irinotecan • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur) • Tomudex (raltitrexed)

1year

A Real-World Comparison of Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer in the United States. (PubMed, J Natl Compr Canc Netw)

This analysis of real-world data found that OS was similar for patients with mCRC who were treated with TAS-102 compared with regorafenib. Median OS with both agents in a real-world setting was similar to that shown in the clinical trials that led to their approvals. A prospective trial comparing TAS-102 and regorafenib would unlikely change current management of patients with refractory mCRC.

1 year ago

Journal • Real-world evidence • Real-world • Metastases

MSI (Microsatellite instability)

Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)

1year

Adeno-associated virus-mediated knockdown demonstrates the major role of hepatic Bcrp in the overall disposition of the active metabolite of the tyrosine kinase inhibitor regorafenib in mice. (PubMed, Drug Metab Pharmacokinet)

AAV-shBcrp-treated mice showed higher M - 5 concentration in plasma and liver, but lower biliary excretion than the control mice, indicating the fundamental role of hepatic Bcrp in M - 5 disposition. This is the first application of AAV-knockdown strategy to clarify the pharmacokinetic role of xenobiotic efflux transporters in the liver.

1 year ago

Preclinical • Journal

CRP (C-reactive protein)

Stivarga (regorafenib)

1year

ReDOS: Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=123, Completed, Academic and Community Cancer Research United | Trial completion date: Jun 2025 --> Mar 2023 | Active, not recruiting --> Completed

1 year ago

Trial completion • Trial completion date • Metastases

KRAS (KRAS proto-oncogene GTPase)

KRAS wild-type • RAS wild-type

Stivarga (regorafenib)

1year

Efficacy of third-line anti-EGFR-based treatment versus regorafenib or trifluridine/tipiracil according to primary tumor site in RAS/BRAF wild-type metastatic colorectal cancer patients. (PubMed, Front Oncol)

Our results demonstrated a different benefit from third-line anti-EGFR-based therapy according to primary tumor site, confirming the role of L-sided tumor in predicting benefit from third-line anti-EGFR vs R/T. At the same time, no difference was observed in R-sided tumor.

1 year ago

Journal • Metastases

BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)

BRAF wild-type

Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)

1year

EGFR and Lyn inhibition augments regorafenib induced cell death in sorafenib resistant 3D tumor spheroid model. (PubMed, Cell Signal)

Patients with unresectable HCC receive systemic therapies, traditionally sorafenib or lenvatinib as first line therapy. Importantly, combined inhibition of EGFR and Lyn kinase in sorafenib resistant tumor spheroids are effective in inducing cell death. Our model proved to be an affordable and useful model to mimic drug resistant tumor microenvironment in HCC and provided novel insights into candidates for new combinational therapies.

1 year ago

Journal

EGFR (Epidermal growth factor receptor) • LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase) • CD24 (CD24 Molecule)

sorafenib • Lenvima (lenvatinib) • Stivarga (regorafenib)

1year

Use of Novel m6A Regulator-mediated Methylation Modification Patterns in Distinct Tumor Microenvironment Profiles to Identify and Predict Glioma Prognosis and Progression, T-cell Dysfunction, and Clinical Response to ICI Immunotherapy. (PubMed, Curr Pharm Des)

Glioma m6A clusters and gene signatures have distinctive TME features. The m6A gene signature may guide prognostic assessments and promote the use of effective strategies.

1 year ago

Journal • Tumor mutational burden • IO biomarker

TMB (Tumor Mutational Burden)

Avastin (bevacizumab) • Stivarga (regorafenib)

1year

Efficacy and Safety of Regorafenib Plus Immune Checkpoint Inhibitors with or Without TACE as a Second-Line Treatment for Advanced Hepatocellular Carcinoma: A Propensity Score Matching Analysis. (PubMed, J Hepatocell Carcinoma)

The difference in the incidence of TRAEs between the two groups was not statistically significant (P> 0.05). Compared to regorafenib plus ICIs, regorafenib plus ICIs with TACE was tolerated and improved survival as the second-line treatment for patients with advanced HCC.

1 year ago

Journal • Checkpoint inhibition • Metastases

AFP (Alpha-fetoprotein)

Stivarga (regorafenib)

1year

Baseline Cytokine Profile Identifies a Favorable Outcome in a Subgroup of Colorectal Cancer Patients Treated with Regorafenib. (PubMed, Vaccines (Basel))

This report suggests that the analysis of multiple cytokines might identify a cytokine signature related to a patient's outcome that is able to recognize patients who will benefit from treatment. If confirmed, future studies, also based on different drugs, using this approach and including larger patient populations, might identify a signature allowing the a priori identification of patients to be treated.

1 year ago

Journal

IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL10 (Interleukin 10) • CCL2 (Chemokine (C-C motif) ligand 2) • TGFB1 (Transforming Growth Factor Beta 1) • IL13 (Interleukin 13) • IL21 (Interleukin 21)

Stivarga (regorafenib)

1year

Insights into the medical management of gastrointestinal stromal tumours: lessons learnt from a dedicated gastrointestinal stromal tumour clinic in North India. (PubMed, Ecancermedicalscience)

The most common change was the use of sunitinib and regorafenib in patients with SDH-deficient GIST. The mutation testing rates at primary care centres continue to be low. Despite the hurdles, a large percentage of our patients underwent molecular testing, aiding in therapeutic decision-making.

1 year ago

Journal • Stroma

KIT (KIT proto-oncogene, receptor tyrosine kinase) • NTRK (Neurotrophic receptor tyrosine kinase)

sunitinib • Stivarga (regorafenib)

1year

Emerging Data on the Safety and Efficacy of Ripretinib for the Treatment of Gastrointestinal Stromal Tumors. (PubMed, Clin Exp Gastroenterol)

Sunitinib and regorafenib are approved in the second- and third-line setting, respectively, with activity against certain secondary mutations with comparatively much lower response rates and survival increment compared to imatinib. Although the efficacy of ripretinib in this unselected patient population was not significantly different from that of sunitinib, the tolerability profile was better. This review article aims to review the efficacy and tolerability profile of ripretinib, together with its role in the setting of unresectable or metastatic GIST.

1 year ago

Clinical • Review • Journal • Stroma

ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)

imatinib • sunitinib • Stivarga (regorafenib) • Qinlock (ripretinib)

1year

Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=0, Withdrawn, CytoDyn, Inc.

1 year ago

New P2 trial • Combination therapy • Metastases

RAS wild-type

Stivarga (regorafenib) • Vyrologix (leronlimab)

over1year

Survival improvement for patients with metastatic colorectal cancer over twenty years. (PubMed, NPJ Precis Oncol)

Notably, survival improved for patients with BRAF mutant as well as microsatellite unstable (MSI-H) tumors. Multivariate regression analysis identified surgical resection of liver metastasis (HR = 0.26, 95% CI, 0.19-0.37), use of immunotherapy (HR = 0.44, 95% CI, 0.29-0.67) and use of third line chemotherapy (regorafenib or trifluridine/tipiracil, HR = 0.74, 95% CI, 0.58-0.95), but not year of diagnosis (HR = 0.99, 95% CI, 0.98-1), as associated with better survival, suggesting that increased use of these therapies are the drivers of the observed improvement in survival.

over 1 year ago

Journal • MSi-H Biomarker • IO biomarker • Metastases

BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)

MSI-H/dMMR • BRAF mutation

Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)

over1year

Regorafenib is suitable for advanced colorectal cancer patients who have previously received trifluridine/tipiracil plus bevacizumab. (PubMed, Sci Rep)

The major grade 3 and4 toxicities were proteinurea (29%), hypertension (26%), hand-foot syndrome(15%), and platelet decrease (6%). Regorafenib after TFTD plus bevacizumab showed efficacy similar to that of the previous study, and no new adverse events were observed.

over 1 year ago

Journal • Metastases

BRAF (B-raf proto-oncogene)

BRAF V600E • BRAF V600 • RAS mutation

Avastin (bevacizumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)

over1year

Clinical activity of regorafenib in elderly patients with recurrent glioblastoma. (PubMed, Mol Clin Oncol)

MGMT methylation appeared to influence OS. To the best of our knowledge, this was the first report of regorafenib activity in older patients and, while the results were statistically significant, these should be confirmed in further studies.

over 1 year ago

Journal

MGMT (6-O-methylguanine-DNA methyltransferase)

Stivarga (regorafenib)

over1year

Updated Efficacy and Safety of Taletrectinib in Patients (pts) with ROS1+ Non-Small Cell Lung Cancer (NSCLC) (ELCC 2023)

CRZ, crizotinib; DCR, disease control rate; NE, not evaluable; ORR, overall response rate; PFS, progression-free survival; TKI, tyrosine kinase inhibitor. Conclusions With additional follow-up, taletrectinib continued to demonstrate meaningful efficacy outcomes including high response rates, prolonged PFS, robust intracranial activity, activity against G2032R, and tolerable safety with low incidence of neurological AEs.

over 1 year ago

Clinical

ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)

ROS1 G2032R

Xalkori (crizotinib) • taletrectinib (AB-106)

over1year

REPROGRAM-01: Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=49, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Trial primary completion date: Jan 2023 --> Jul 2023

over 1 year ago

Trial primary completion date • Combination therapy • Metastases

KRAS (KRAS proto-oncogene GTPase)

RAS wild-type • NRAS wild-type

capecitabine • cyclophosphamide • Stivarga (regorafenib)

over1year

MegaMOST: A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (clinicaltrials.gov)

P2, N=425, Recruiting, Centre Leon Berard | Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Feb 2024 --> Feb 2026

over 1 year ago

Trial completion date • Trial primary completion date • Metastases

KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • HRAS (Harvey rat sarcoma viral oncogene homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • AXL (AXL Receptor Tyrosine Kinase) • CCND1 (Cyclin D1) • CDK4 (Cyclin-dependent kinase 4) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • SMAD4 (SMAD family member 4) • RAF1 (Raf-1 Proto-Oncogene Serine/Threonine Kinase) • FLT1 (Fms-related tyrosine kinase 1) • CDK6 (Cyclin-dependent kinase 6) • CCND3 (Cyclin D3) • TYRO3 (TYRO3 Protein Tyrosine Kinase) • NTRK (Neurotrophic receptor tyrosine kinase)

KRAS mutation • EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR1 amplification • CDKN2A deletion • HRAS mutation • PTPN11 mutation • CCND1 amplification • KRAS amplification • BRAF amplification

Mekinist (trametinib) • Tafinlar (dabrafenib) • Alecensa (alectinib) • Cabometyx (cabozantinib tablet) • Stivarga (regorafenib) • Kisqali (ribociclib) • siremadlin (HDM201)

over1year

Current therapeutic modalities and chemopreventive role of natural products in liver cancer: Progress and promise. (PubMed, World J Hepatol)

Sorafenib and lenvatinib are first-line therapies, while regorafenib and ramucirumab are second-line therapy. Drug-induced toxicity is a key obstacle in the treatment of liver cancer, necessitating the development of effective and safe medications, with natural compounds such as resveratrol, curcumin, diallyl sulfide, and others emerging as promising anticancer agents. This review highlights the current status of liver cancer research, signaling pathways, therapeutic targets, current treatment strategies and the chemopreventive role of various natural products in managing liver cancer.

over 1 year ago

Review • Journal

TGFB1 (Transforming Growth Factor Beta 1)

sorafenib • Lenvima (lenvatinib) • Stivarga (regorafenib) • Cyramza (ramucirumab)

over1year

Guardant Health and AnHeart Therapeutics Announce Collaboration to Develop Guardant360 CDx and Guardant360 TissueNext as Companion Diagnostics for Taletrectinib in Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (Businesswire)

"Guardant Health Inc...announced today a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360^®CDx and Guardant360 TissueNext™ assays as companion diagnostics for taletrectinib in the United States and European Union....The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib."

over 1 year ago

Licensing / partnership

Guardant360® CDx • Guardant360 TissueNext™

taletrectinib (AB-106)

over1year

Efficacy and Safety of Sintilimab Combined With Regorafenib and Cetuximab / Sintilimab Combined With Regorafenib in Posterior Line Therapy of Advanced Colorectal Cancer (Regosinti) (clinicaltrials.gov)

P2, N=90, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2023

over 1 year ago

Enrollment open • Trial completion date • Trial primary completion date • Metastases

BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)

Erbitux (cetuximab) • Tyvyt (sintilimab) • Stivarga (regorafenib)

over1year

Phase II Trial of Regorafenib and Oral Methotrexate in Previously Treated Advanced KRAS Mutant Non-Small Cell Lung Cancer (IASLC-TTLC 2023)

In addition, the study did not meet its primary endpoint. Analysis of circulating tumor DNA (ctDNA) dynamics during study treatment is ongoing.

over 1 year ago

P2 data • Metastases

KRAS (KRAS proto-oncogene GTPase)

KRAS mutation • KRAS G12D • KRAS G12V • KRAS G12R • KRAS G12S • KRAS A146V • KRAS Q61L

Stivarga (regorafenib) • methotrexate

over1year

An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe (clinicaltrials.gov)

P=N/A, N=300, Completed, Bayer | Active, not recruiting --> Completed

over 1 year ago

Trial completion • HEOR • Real-world evidence • Real-world • Metastases

KRAS (KRAS proto-oncogene GTPase)

KRAS mutation • NRAS mutation • RAS mutation

Stivarga (regorafenib)

over1year

REPROGRAM-01: Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer (clinicaltrials.gov)

P2, N=49, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting

over 1 year ago

Enrollment closed • Combination therapy • Metastases

KRAS (KRAS proto-oncogene GTPase)

RAS wild-type • NRAS wild-type

capecitabine • cyclophosphamide • Stivarga (regorafenib)