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Gilead Sciences/Arcus Biosciences' Investigational Cancer Drug Shows Overall Survival Of Around 27 Months
Benzingaยท 2025-10-13 14:33
Core Insights - Arcus Biosciences Inc. announced the first overall survival results from Arm A1 of the Phase 2 EDGE-Gastric study for patients with advanced gastric cancer [1] - The study evaluates the safety and efficacy of domvanalimab plus zimberelimab and chemotherapy [1][2] Study Details - The Phase 2 EDGE-Gastric study is a multi-arm global trial conducted in partnership with Gilead Sciences Inc. [2] - Patients in Arm A1 received a regimen of domvanalimab (1600mg IV every four weeks), zimberelimab (480mg IV every four weeks), and FOLFOX chemotherapy every two weeks [3] - The cohort demonstrated a median overall survival of 26.7 months [3] Efficacy Results - The study reported a confirmed overall response rate of 59% and a median progression-free survival of 12.9 months [4] - Richard Markus, chief medical officer of Arcus, emphasized the differentiated efficacy and safety of the anti-TIGIT-based combinations [4] Safety Profile - No unexpected safety signals were observed, and the treatment regimen was generally well tolerated [5] Market Reaction - Following the announcement, Arcus Biosciences' stock increased by 6.58%, reaching $15.56 [5]
Arcus Biosciences (NYSE:RCUS) 2025 R&D Day Transcript
2025-10-06 15:02
Summary of Arcus Biosciences Investor Event - October 2025 Company Overview - **Company**: Arcus Biosciences - **Focus**: Development of innovative cancer therapies, particularly in renal cell carcinoma (RCC) and immunology - **Key Programs**: Castadafen (HIF2 inhibitor), domvanalimab (anti-TIGIT), quemliclustat (CD73 inhibitor) - **Financial Position**: Over $900 million in funding to support late-stage programs and clinical trials [7][8][14] Key Points on Castadafen - **Priority Program**: Castadafen is the highest priority program due to its scientific, clinical, and commercial validation [3][4] - **Market Potential**: The clear cell RCC market opportunity is estimated at approximately $5 billion, with additional potential in other cancers leading to a total market exceeding $10 billion [15][18] - **Clinical Data**: - Castadafen shows approximately twice the progression-free survival (PFS) compared to belzutifan, with a 50% lower rate of primary progression [17][43] - Confirmed overall response rate (ORR) for castadafen is 35%, compared to 22% for belzutifan [32][43] - Median PFS for castadafen is projected to exceed 12 months, with 60% of patients remaining progression-free at 12 months [40][41] - **Safety Profile**: Castadafen has a comparable safety profile to belzutifan, with serious adverse events (SAEs) at 31% and treatment-related SAEs at 6% [43][44] Other Programs - **Domvanalimab**: Focused on upper GI cancers, with an oral presentation at ESMO expected to provide overall survival data [5][6] - **Quemliclustat**: CD73 inhibitor showing unprecedented overall survival of 16.4 months in combination with gemcitabine/nab-paclitaxel [6][14] Clinical Trials and Collaborations - **PEAK-1 Study**: Ongoing phase 3 study for castadafen in frontline clear cell RCC, with strong enrollment expected due to investigator enthusiasm [12][14] - **Collaboration with AstraZeneca**: Cost-sharing arrangement while maintaining 100% commercial rights to castadafen [13][14] - **Taiho Collaboration**: Potential decision from Taiho regarding participation in the castadafen program [13] Market Competition - **Competitive Landscape**: Competing against major players like Merck and Roche, with a focus on addressing significant medical needs in large markets [14][15] - **Strategic Positioning**: Arcus aims to leverage its well-funded status and strong data to capture market share in the competitive landscape of RCC treatments [14][15] Insights from Key Opinion Leaders - **Dr. Raina McKay**: Emphasized the need for improved treatment options in RCC, highlighting the limitations of current therapies like belzutifan [48][52] - **Patient Journey**: Discussed the typical RCC patient journey and the importance of long-term treatment strategies [49][50] Conclusion - **Future Outlook**: Arcus Biosciences is well-positioned to capitalize on its innovative therapies, particularly castadafen, with strong clinical data and a robust financial foundation to support ongoing and future studies [7][8][15]