Favezelimab

Merck is discontinuing clinical development of vibostolimab (anti-TIGIT) and favezelimab (anti-LAG-3) antibodies due to futility in phase 3 trials. KeyVibe-003 and KeyVibe-007 met futility criteria for overall survival in non-small cell lung cancer, while KEYFORM-008 for relapsed/refractory Hodgkin lymphoma is ending enrollment. No new safety signals were identified, but immune-related adverse events were more common with dual checkpoint inhibitor therapy.

Merck has discontinued the KeyVibe and KEYFORM programs investigating vibostolimab and favezelimab, citing data analysis and prioritization of other programs. KeyVibe-003 and KeyVibe-007 trials met futility criteria for overall survival, while KEYFORM-007 failed to meet its primary endpoint. Data analyses continue, with results to be shared with the scientific community.

Merck discontinues clinical development of vibostolimab and favezelimab, citing futility in Phase 3 trials. KeyVibe-003 and KeyVibe-007 met futility criteria for overall survival in non-small cell lung cancer. Safety profiles were consistent with prior studies. KEYFORM-008 enrollment halted for relapsed or refractory Hodgkin lymphoma. Merck prioritizes other oncology candidates.

Merck discontinues vibostolimab and favezelimab clinical programs due to futility in Phase 3 trials, prioritizing other oncology candidates.

Dr. Shilpa Gupta presented the study design of Cohort C of the phase II KEYNOTE-057 trial, comparing co-formulations of Vibostolimab/pembrolizumab and Favezelimab/pembrolizumab for BCG-unresponsive, high-risk NMIBC at the 2024 SUO annual meeting. The study aims to evaluate the efficacy and safety of these combinations in 60 patients with BCG-unresponsive CIS +/- papillary disease.

Merck's Phase 3 KEYNOTE-689 trial of Keytruda met its primary endpoint of event-free survival (EFS) as a perioperative treatment for stage III or IVA resected, locally advanced head and neck squamous cell carcinoma, showing statistically significant improvements in EFS and major pathological response (mPR). The safety profile remained consistent with previous studies, and a trend toward improved overall survival (OS) was observed, though OS results did not reach statistical significance at the first interim analysis.

A phase 3 trial comparing an investigational combination with standard care for advanced colorectal cancer failed to meet its primary endpoint of OS. The trial included 441 patients with PD-L1-positive, microsatellite stable metastatic colorectal cancer. The experimental combination of favezelimab and pembrolizumab showed no OS improvement compared to standard care, with a safety profile consistent with prior reports.

The phase 3 KEYFORM-007 trial found no improvement in overall survival with favezelimab plus pembrolizumab vs standard care in PD-L1-positive, microsatellite stable metastatic colorectal cancer. Safety remained consistent with prior studies.

Merck's Keytruda combined with favezelimab failed to improve survival in Phase III KEYFORM-007 study for metastatic colorectal cancer, despite confirming safety profiles. Merck plans to continue evaluating Keytruda-based combinations for colorectal cancer.

Merck's Phase 3 KEYFORM-007 trial of favezelimab and pembrolizumab for PD-L1 positive MSS mCRC did not meet OS primary endpoint, with no new safety signals. Ongoing studies include KEYFORM-008 for relapsed or refractory classical Hodgkin lymphoma.