Vibostolimab

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.

BioAge Labs halted azelaprag trials due to safety concerns; Biohaven's taldefgrobep alfa showed muscle-preserving effects in failed SMA trial, prompting obesity study. Roche's tiragolumab failed phase 3, dimming anti-TIGIT drug prospects; Gilead/Arcus' domvanalimab shows promise. AbbVie's emraclidine failed schizophrenia trials, impacting market cap. Cassava's simufilam failed Alzheimer's phase 3, amid SEC investigation.

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.

The phase 3 KEYVIBE-008 trial found that co-formulated vibostolimab and pembrolizumab plus etoposide and platinum did not meet the primary end point of overall survival (OS) in extensive-stage small cell lung cancer (ES-SCLC) compared to atezolizumab plus EP. Median OS was 11.5 months vs 12.9 months, and median progression-free survival (PFS) was 5.3 months vs 4.5 months. The trial was discontinued due to the benefit/risk profile, though investigation continues in non–small cell lung cancer (NSCLC).

Recent Phase II data from iTeos and GSK's anti-TIGIT therapy belrestotug plus anti-PD-1 Jemperli shows promising response rates in NSCLC patients, despite high-profile failures in the TIGIT space. Despite setbacks, companies like Roche and Merck continue TIGIT studies, emphasizing trial design's impact on outcomes. Insights suggest anti-TIGIT therapy may benefit patients with high CD-155 expression, potentially as combination therapy. Recent positive results from iTeos/GSK and Gilead/Arcus indicate a possible turning tide in TIGIT therapeutics.

GSK and iTeos Therapeutics' Phase II GALAXIES Lung-201 study showed Jemperli and belrestotug, an anti-TIGIT therapy, achieved a 60% objective response rate in non-small cell lung cancer patients, with a 30% improvement over Jemperli alone. The combination also led to significant reductions in circulating tumor DNA and was presented at ESMO 2024.

GSK and iTeos presented belrestotug + Jemperli data at ESMO 2024, showing doubled ORR in NSCLC, but lacking survival insights. Belrestotug 400mg is the RP3D for Phase III trial vs. Keytruda. TIGIT inhibitors face competition from Roche, Arcus/Gilead, and AstraZeneca, with market potential of $871m by 2030.