Zimberelimab

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.

DelveInsight's report on PD-1 Non-Small Cell Lung Cancer Market (2020-2034) highlights market growth, approvals, prevalence, therapies, and companies like Merck, Bristol-Myers Squibb, Genentech, and others. Key therapies include KEYTRUDA, OPDIVO, TECENTRIQ, and TIZVENI. Market drivers include premium-priced targeted agents and therapy expansion, while barriers include premium pricing of emerging therapies.

The National Reimbursement Drug List (NRDL) faces budget pressure and competition, with 445 drugs passing formal review in 2024. Oncology, immunology, neurology, and rare diseases see strategic positioning and comparator choices as key. Contract renewals and re-negotiations are under pressure, emphasizing clear messaging and data preparation for NRDL success.

Domvanalimab/zimberelimab improved overall survival (OS) and progression-free survival (PFS) vs. zimberelimab monotherapy and platinum-based chemotherapy in phase 3 ARC-10 study for first-line advanced NSCLC with PD-L1 ≥50%. Median OS not reached with domvanalimab/zimberelimab, 24.4 months with zimberelimab, and 11.9 months with chemotherapy. Median PFS was 11.5 months with domvanalimab/zimberelimab, 6.2 months with zimberelimab, and 9.6 months with chemotherapy. Full results to be presented at SITC 2024.

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.

Arcus Biosciences and AstraZeneca collaborate on a clinical trial to evaluate the combination of Arcus's HIF-2a inhibitor casdatifan and AstraZeneca's PD-1/CTLA-4 bispecific antibody volrustomig in clear cell renal cell carcinoma patients. This is their second collaboration, following the 2020 PACIFIC-8 trial. Arcus also shares positive results from the Phase II EDGE-Gastric study, showing improved progression-free survival with domvanalimab plus zimberelimab and chemotherapy in upper GI cancers.

Arcus Biosciences partners with AstraZeneca for a clinical trial to assess the safety and efficacy of combining casdatifan (HIF-2a inhibitor) and volrustomig (PD-1/CTLA-4 bispecific antibody) in clear cell renal cell carcinoma patients.

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.

DelveInsight's 'Non-Small-Cell Lung Cancer Pipeline Insight 2024' covers 135+ companies and 150+ pipeline drugs, highlighting key players like BridgeBio Pharma, Daiichi Sankyo, and Merck. Prominent therapies include Trastuzumab deruxtecan, DS-1062a, and Pembrolizumab. Recent studies by Merck, AstraZeneca, and Gilead focus on Phase 3 trials for V940, Durvalumab, and Zimberelimab, respectively.