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DRUG CLASS:

PD1 inhibitor

Related drugs:
1d
Concordance Among Three Programmed Death-Ligand 1 (PD-L1) Scoring Methods and Their Association With Clinical Outcomes of Tislelizumab (TIS) Monotherapy in Esophageal Squamous Cell Carcinoma (ESCC) (AIOM 2024)
OS subgroup analysis showed comparable treatment effect by TAP score at 10% cutoff, CPS at cutoff 10, and TC score at 1% cutoff. TAP score and CPS at these cutoffs exhibited substantial concordance. Results indicate that the quicker, visually estimated TAP score and CPS may be interchangeable for clinical measurement of PD-L1 expression in patients with ESCC.
Clinical • Clinical data • PD(L)-1 Biomarker • IO biomarker • Discordant
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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VENTANA PD-L1 (SP263) Assay
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Tevimbra (tislelizumab-jsgr)
1d
Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer. (PubMed, J Immunother Cancer)
Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab.
Journal
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FOXP3 (Forkhead Box P3) • TLR3 (Toll Like Receptor 3) • IFNA1 (Interferon Alpha 1)
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Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Ampligen (rintatolimod) • celecoxib oral
1d
Role of Immunotherapy in Conjunction With the Surgical Treatment of Breast Cancer: Preoperative and Postoperative Applications. (PubMed, Cureus)
Fourteen different articles showed that the use of cytokines and cancer vaccines revealed new possibilities to treat breast cancer with antibodies against PD-1/PD-L1 (pembrolizumab), PI3K/Akt/mTOR (alpelisib and everolimus), CAR T-cell (chimeric antigen receptor), PARP (poly ADP-ribose polymerase), and CTLA4 (cytotoxic T-lymphocyte-associated protein 4), and with representative relevance of changing in tumor microenvironment. Estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) targets show also a high effectivity. In recent years, the release of new strategies has become promising, for changing the microenvironment and de-escalation of therapy based on tumor biology, novel biomarkers, and tumor spread.
Review • Journal • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
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Keytruda (pembrolizumab) • everolimus • Piqray (alpelisib)
1d
Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. (PubMed, JAMA Oncol)
To evaluate the efficacy and safety of toripalimab plus etoposide and platinum-based chemotherapy (EP) vs placebo plus EP as a first-line treatment for patients with ES-SCLC. The treatment exhibited an acceptable safety profile, supporting this combination regimen as a new treatment option for patients with ES-SCLC. ClinicalTrials.gov Identifier: NCT04012606.
Clinical • P3 data • Journal
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KMT2D (Lysine Methyltransferase 2D)
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HLA-A*11
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Loqtorzi (toripalimab-tpzi) • etoposide IV
2d
CAF-macrophage crosstalk in tumour microenvironments governs the response to immune checkpoint blockade in gastric cancer peritoneal metastases. (PubMed, Gut)
Our findings provide a new molecular portrait of cell compositions associated with ICB resistance in patients with GCPM and aid in the prioritisation of therapeutic candidates to potentiate immunotherapy.
Journal • Checkpoint inhibition • Checkpoint block
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SPP1 (Secreted Phosphoprotein 1) • THBS2 (Thrombospondin 2)
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Tyvyt (sintilimab)
2d
Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study. (PubMed, Med)
Neoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.
P2 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
2d
Efficacy and Safety of a Therapy Combining Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Nonsquamous Non-Small Cell Lung Cancer: Protocol for a Phase II, Pilot, Single-Arm, Single-Center Study. (PubMed, JMIR Res Protoc)
This study will provide evidence for the efficacy and safety of the combination of immunochemotherapy and cryoablation as a first-line treatment for advanced NSCLC. Although it has a limited sample size, the findings of this study will be used in the future to inform the design of a fully powered, 2-arm, larger-scale study.
P2 data • Journal • Metastases
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NECTIN1 (Nectin Cell Adhesion Molecule 1)
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Tyvyt (sintilimab)
2d
Inhibition of Bruton's tyrosine kinase with PD-1 blockade modulates T cell activation in solid tumors. (PubMed, JCI Insight)
BACKGROUNDInhibition of Bruton's tyrosine kinase with ibrutinib blocks the function of myeloid-derived suppressor cells (MDSC). The addition of nivolumab significantly increased circulating NK and CD8+ T cells and increased CD8+ T cell proliferation. Exploratory analyses suggest that MDSC and T cell gene expression and TCR repertoire diversity were differentially affected by BTK inhibition according to patient response.CONCLUSIONIbrutinib and nivolumab were well tolerated and affected MDSC and T cell function in patients with solid metastatic tumors.TRIAL REGISTRATIONClinicalTrials.gov NCT03525925.FUNDINGNIH; National Cancer Institute Cancer; National Center for Advancing Translational Sciences; Pelotonia.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • TIMP1 (Tissue inhibitor of metalloproteinases 1) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL3 (C-C Motif Chemokine Ligand 3)
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Opdivo (nivolumab) • Imbruvica (ibrutinib)
2d
Analysis of the treatment efficacy and prognostic factors of PD-1/PD-L1 inhibitors for advanced gastric or gastroesophageal junction cancer: a multicenter, retrospective clinical study. (PubMed, Front Immunol)
Factors for improved PFS include early treatment, lower T stage, fewer metastatic sites, and lower pre-IBIL, post-GLOB, and post-CA125 levels. Nomogram models can help identify patients who may benefit from immunotherapy, providing valuable clinical guidance.
Retrospective data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MUC16 (Mucin 16, Cell Surface Associated) • CA 19-9 (Cancer antigen 19-9)
2d
Clinical significance of early kinetics of C‑reactive protein in patients with advanced urothelial carcinoma treated with pembrolizumab: Flare response and baseline levels predict oncological outcomes. (PubMed, Oncol Lett)
Notably, there was no difference in the incidence of immune-related AEs. In patients with mUC who received pembrolizumab, CRP flare-responders showed favorable oncological outcomes; therefore, BL CRP levels could predict oncological outcomes in CRP flare-responders.
Journal • Metastases
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CRP (C-reactive protein)
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Keytruda (pembrolizumab)
3d
Triple negative breast cancer: Current status and perspectives (PubMed, Bull Cancer)
Dose-dense chemotherapy regimens and the addition of carboplatin have been associated with an improvement in these response rates. Furthermore, immunotherapy, particularly pembrolizumab, has shown significant benefits in terms of recurrence-free survival...In conclusion, despite recent progress, TNBC remains a major clinical challenge. A better understanding of its biology and a personalized therapeutic approach are essential to improve clinical outcomes for patients with this aggressive form of breast cancer.
Review • Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset)
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HER-2 overexpression • BRCA mutation
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Keytruda (pembrolizumab) • carboplatin
3d
The addition of PD-1 inhibitor overcame trastuzumab resistance in patients with HER2 positive, PD-L1 negative metastatic gastric cancer: Case report and review of literature. (PubMed, Front Pharmacol)
His resistance to trastuzumab was overcome after the addition of a PD-1 inhibitor, after which he received a durable response for more than 8 months. In HER2-positive, PD-L1-negative metastatic GC, the addition of PD-1 inhibitors after first-line chemotherapy and trastuzumab treatment resistance may be an option.
Review • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • HER-2 positive • PD-L1 negative
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Herceptin (trastuzumab)
3d
Special entities of the head and neck region: cancers of the nasopharynx, (para)nasal cavities, salivary glands, and the thyroid gland : Post ASCO 2024 (PubMed, HNO)
In the treatment of locally advanced NPC, a randomized phase III study showed equivalence of induction (ICT) and adjuvant therapy (AT; NCT03306121). PD-1 inhibitors have become established in the palliative therapy of NPC in recent years and could now also play an increasing role in curation: the phase III study "Dipper" showed a significantly better 3‑year event-free survival in patients adjuvantly treated with camrelizumab versus placebo after IT and definitive platinum-containing chemoradiotherapy (dRCT; 89% vs. 80%; NCT03427827). The phase III study "Beacon" showed complete remission in 30.5% of patients after IT with gemcitabine/cisplatin and the PD‑1 inhibitor tislelizumab (three cycles), a rate almost twice as high as with gemcitabine/cisplatin alone (NCT05211232). Intensification of dRCT in NPC using EGFR and VEGF inhibitors appears promising (NCT04447326). Abstracts on salivary gland and nasal and sinus cancers emphasize the importance of targeted therapies. In anaplastic thyroid carcinoma, the combination of a PD‑1 inhibitor and a CTLA4 inhibitor showed a 50% response.
Review • Journal
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EGFR (Epidermal growth factor receptor)
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cisplatin • gemcitabine • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
3d
Comparative efficacy of combined CTLA-4 and PD-1 blockade vs. PD-1 monotherapy in metastatic melanoma: a real-world study. (PubMed, BJC Rep)
Our real-world data indicate that combined CTLA-4 and PD-1 blockade is most beneficial for patients with multi-organ metastasis, while those with oligo-organ metastasis fare better with PD-1 monotherapy. The underlying reasons for these observations-whether they are due to differences in the characteristics of multi- and oligo-metastatic melanomas or the risk-benefit profile of the therapies-remain to be elucidated. These findings underscore the need for a nuanced approach to treatment regimens for stage IV melanoma patients.
Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
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BRAF (B-raf proto-oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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BRAF mutation
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
3d
Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe. (PubMed, Cancers (Basel))
The results of this study offer insights into the real-world use of pembrolizumab as an adjuvant therapy for melanoma in Europe.
Journal • Real-world evidence • Real-world
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BRAF (B-raf proto-oncogene)
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Keytruda (pembrolizumab)
3d
PERCEPTION: Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer (clinicaltrials.gov)
P2, N=33, Recruiting, North Eastern German Society of Gynaecological Oncology | Trial primary completion date: Nov 2024 --> Apr 2025
Trial primary completion date
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Keytruda (pembrolizumab) • carboplatin
3d
Neoadjuvant Camrelizumab with Palbociclib for Resectable Esophageal Squamous Cell Carcinomas (clinicaltrials.gov)
P1, N=6, Recruiting, West China Hospital | Trial primary completion date: Oct 2024 --> Oct 2025
Trial primary completion date
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Ibrance (palbociclib) • AiRuiKa (camrelizumab)
3d
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
P1, N=98, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: May 2025 --> Dec 2024
Trial primary completion date • Combination therapy • Metastases
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spartalizumab (PDR001) • DKY709
3d
New P2 trial • Metastases
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sorafenib • Loqtorzi (toripalimab-tpzi) • Inlyta (axitinib) • tifcemalimab (TAB004)
3d
EPOC2001: An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients with Gastric Cancer (clinicaltrials.gov)
P2, N=43, Active, not recruiting, National Cancer Center Hospital East | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2025 --> Aug 2026
Enrollment closed • Trial primary completion date
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Keytruda (pembrolizumab) • docetaxel • 5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • levoleucovorin calcium
3d
APiTOXMM: Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management (clinicaltrials.gov)
P=N/A, N=160, Recruiting, University Hospital, Montpellier | Not yet recruiting --> Recruiting
Enrollment open
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
3d
Enrollment open • Surgery
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Keytruda (pembrolizumab)
3d
Enrollment change
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Keytruda (pembrolizumab) • carboplatin • paclitaxel
3d
KEYNOTE-E64: Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (clinicaltrials.gov)
P1/2, N=316, Recruiting, Simcha IL-18, Inc. | Active, not recruiting --> Recruiting | Trial completion date: Jan 2025 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Jun 2025
Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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TMB-H • MSI-H/dMMR • ALK positive • ALK mutation
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Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • vevoctadekin (ST-067)
3d
Nivolumab with or Without Ipilimumab in Treating Patients with Recurrent or High Grade Gynecologic Cancer with Metastatic Peritoneal Carcinomatosis (clinicaltrials.gov)
P1, N=26, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Nov 2024 | Trial primary completion date: Apr 2025 --> Nov 2024
Trial completion • Trial completion date • Trial primary completion date • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab)
3d
Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer (clinicaltrials.gov)
P1, N=78, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
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CD8 (cluster of differentiation 8) • HGF (Hepatocyte growth factor) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • FGF (Fibroblast Growth Factor) • MLANA (Melan-A)
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Keytruda (pembrolizumab) • Zaltrap (ziv-aflibercept IV)
3d
PSMA Therapy and Immunotherapy in Kidney Cancer (clinicaltrials.gov)
P1/2, N=37, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2031 --> Jan 2032 | Initiation date: Nov 2024 --> May 2025 | Trial primary completion date: Jul 2030 --> Jan 2031
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
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Keytruda (pembrolizumab) • lutetium zadavotide guraxetan (PNT2002)
3d
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01) (clinicaltrials.gov)
P2, N=30, Recruiting, First Affiliated Hospital of Zhejiang University | N=50 --> 30 | Trial completion date: Oct 2029 --> Jun 2029 | Initiation date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2026 --> Jun 2026
Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin
3d
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) (clinicaltrials.gov)
P2, N=15, Active, not recruiting, National Cancer Institute (NCI) | N=40 --> 15 | Trial completion date: Sep 2027 --> Nov 2025 | Trial primary completion date: Sep 2027 --> Sep 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD69 (CD69 Molecule) • TFE3 (Transcription Factor Binding To IGHM Enhancer 3) • CD14 (CD14 Molecule) • CD24 (CD24 Molecule) • ITGAM (Integrin, alpha M) • FOXP3 (Forkhead Box P3)
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PD-L1 expression • PD-1 expression • TFEB translocation
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Opdivo (nivolumab) • Inlyta (axitinib) • ABP 206 (nivolumab biosimilar)
3d
Survival outcomes of patients with gastric cancer treated with first-line nivolumab plus chemotherapy based on claudin 18.2 expression. (PubMed, Gastric Cancer)
The efficacy of nivolumab plus chemotherapy did not vary according to claudin 18.2 positivity. The clinical benefit of nivolumab plus chemotherapy over chemotherapy was consistently observed in claudin 18.2-positive and -negative gastric cancer cases.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
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Opdivo (nivolumab)
3d
Enrollment open
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carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • goserelin acetate
3d
New P1 trial
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cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
3d
Trial completion
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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Keytruda (pembrolizumab) • Lenvima (lenvatinib)
3d
New P2 trial
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Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel
3d
Enrollment open • Metastases
3d
Iparomlimab (QL1604) in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic solid tumors: a pivotal, single-arm, multicenter, phase II trial. (PubMed, J Hematol Oncol)
No iparomlimab-related death occurred. Iparomlimab presented encouraging antitumor activity with durable response and tolerable safety profile.Trial registration ClinicalTrials.gov Identifier: NCT04326829.
P2 data • Journal • Mismatch repair • Microsatellite instability • Metastases
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MSI (Microsatellite instability)
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MSI-H/dMMR
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iparomlimab (QL1604)
3d
Systemic therapy for non-clear cell renal cell carcinomas: A systematic review. (PubMed, J Oncol Pharm Pract)
While combination therapies, including immunotherapies, have shown positive outcomes, immune checkpoint inhibitors like nivolumab and pembrolizumab have demonstrated encouraging antitumor activity. Additionally, targeting the c-MET pathway has proven effective in certain papillary RCC. Further research is warranted to establish optimal treatment strategies and improve outcomes for patients with non-clear cell RCC. Systemic therapy for non-clear cell RCC is complex and evolving. Further research is needed to delineate optimal treatment strategies for different histological subtypes and improve patient outcomes.
Review • Journal
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MET (MET proto-oncogene, receptor tyrosine kinase)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • sunitinib • Torisel (temsirolimus)
3d
Trial primary completion date • Metastases
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Opdivo (nivolumab) • Repatha (evolocumab)
3d
RELATIVITY-106: A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (clinicaltrials.gov)
P1/2, N=162, Recruiting, Bristol-Myers Squibb | Trial primary completion date: Jun 2024 --> Oct 2025
Trial primary completion date • Combination therapy • Metastases
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Opdivo (nivolumab) • Avastin (bevacizumab) • relatlimab (BMS-986016)
3d
A phase II study of induction PD-1 blockade (nivolumab) in patients with surgically completely resectable mismatch repair deficient endometrial cancer (NIVEC). (PubMed, J Gynecol Oncol)
Correlative studies include genomic characterization of tumors, assessment of immune infiltration of tumor microenvironment, and serial circulating cell-free DNA and immune biomarkers. ClinicalTrials.gov Identifier: NCT05795244.
P2 data • Journal • Mismatch repair • PD(L)-1 Biomarker • IO biomarker
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Opdivo (nivolumab)
4d
Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). (PubMed, Gynecol Oncol)
All primary and secondary efficacy assessments demonstrate the consistent benefit of dostarlimab plus carboplatin-paclitaxel. The improvements seen in survival and the manageable safety profile support the favorable benefit-risk profile for dostarlimab plus carboplatin-paclitaxel in patients with dMMR/MSI-H primary advanced or recurrent EC.
P3 data • Journal • Combination therapy • Metastases
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MSI (Microsatellite instability)
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MSI-H/dMMR
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carboplatin • paclitaxel • Jemperli (dostarlimab-gxly)
4d
Adjuvant Immune Checkpoint Inhibitors for Muscle-Invasive Urothelial Carcinoma: An Updated Systematic Review, Meta-analysis, and Network Meta-analysis. (PubMed, Target Oncol)
Our analyses demonstrated the DFS and OS benefits of adjuvant ICIs for high-risk MIUC. Furthermore, patients with bladder cancer who underwent neoadjuvant chemotherapy appeared to be the optimal candidates for adjuvant ICIs regarding prolonged DFS. Adjuvant ICIs are the standard of care for high-risk MIUC, and differential clinical behaviors and efficacy will enrich clinical decision-making.
Retrospective data • Review • Journal • Checkpoint inhibition
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab)