Arcus Biosciences and Gilead Halt Phase 3 STAR-221 Cancer Study Due to Lack of Efficacy
Discontinuation of STAR-221 Study: Arcus Biosciences has halted the Phase 3 STAR-221 study, which evaluated a domvanalimab-based treatment for upper gastrointestinal cancers, due to a lack of efficacy as determined by an interim analysis.
Comparison of Treatment Efficacy: The interim analysis revealed that the domvanalimab combination did not improve overall survival compared to nivolumab plus chemotherapy, with similar safety profiles for both treatments.
Focus on Casdatifan Development: Following the study's discontinuation, Arcus is shifting its focus to the development of casdatifan, a HIF-2a inhibitor, with multiple data readouts anticipated in 2026.
Financial Stability: Arcus has approximately $1 billion in cash and investments, which is expected to support its operations through at least the second half of 2028, while also pursuing new programs targeting inflammatory and autoimmune diseases.
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- Job Data Expectations: The U.S. is expected to add 60,000 jobs in January, up from 50,000 in December, which could influence the Fed's monetary policy direction amidst ongoing economic uncertainty.
- Inflation Metrics Analysis: The January Consumer Price Index is projected to rise by 0.29% month-over-month and 2.5% year-over-year, showing improvement but still falling short of the Fed's 2% target, potentially affecting investor rate expectations.
- Market Reaction and Risks: Recent signs of labor market weakness, including an ADP report indicating only 22,000 new private sector jobs, may heighten expectations for further Fed rate cuts, although investors remain optimistic about economic resilience.
- Stock Market Rotation Trend: A significant rotation within the stock market is underway, with the Dow Jones Industrial Average rising over 2% this week, reflecting confidence in economic recovery, despite ongoing weakness in tech stocks.
- FDA Approval Update: Gilead's Kite unit announced that the FDA has approved a label update for its CAR-T therapy Yescarta, removing usage limitations for patients with relapsed or refractory primary central nervous system lymphoma, significantly broadening the therapy's applicability.
- First Unrestricted Therapy: Yescarta becomes the first CAR-T therapy for relapsed or refractory large B-cell lymphoma to have these restrictions lifted, which will help more patients access treatment and enhance the company's competitive position in this field.
- Clinical Data Support: The FDA's decision is backed by favorable safety data from a Phase 1 study that tested the autologous T cell immunotherapy in lymphoma patients, including those with relapsed or refractory primary central nervous system lymphoma, demonstrating good safety and efficacy.
- Market Potential Boost: This label update not only opens new market opportunities for Gilead but may also drive sales growth for Yescarta, further solidifying its leadership position in the CAR-T therapy market.
- FDA Approval Update: Gilead Sciences' Kite announced on Friday that its new treatment has received approval from the U.S. Food and Drug Administration (FDA), marking a significant advancement in the company's cell therapy portfolio that could drive future sales growth.
- Positive Market Reaction: This FDA approval is expected to boost investor confidence, potentially leading to a positive impact on Gilead's stock price, reflecting market recognition of its innovative treatment solutions.
- Strategic Implications: The approval not only strengthens Kite's position in the highly competitive biopharmaceutical market but also opens up new revenue streams for the company, further solidifying its leadership in the cell therapy sector.
- Future Outlook: With FDA approval, Kite is poised to accelerate its product launch process, addressing the growing patient demand while laying the groundwork for the company's expansion in global markets.
- FDA Approval Update: The FDA has approved an update to Yescarta's prescribing information, removing limitations for use in patients with relapsed or refractory primary central nervous system lymphoma, marking a significant advancement in treatment options for this rare and aggressive lymphoma.
- Reinforced Safety Data: The updated label highlights the safety profile of Yescarta in eligible patients, with 85% experiencing neurologic toxicities and 31% reporting Grade 3 toxicities, indicating the need for careful assessment of treatment risks versus benefits.
- Addressing Clinical Needs: With a five-year survival rate of only 30% for primary CNS lymphoma, the FDA's decision provides new treatment options for this underserved patient population, potentially improving survival outcomes.
- Research-Backed Decision: The FDA's approval is based on positive results from a Phase 1 study conducted by Dana-Farber Cancer Institute, emphasizing Yescarta's unique position in this therapeutic area and potentially increasing clinical research and patient acceptance.
- FDA Approval Update: Kite announced that the FDA has approved an update to Yescarta's prescribing information, removing use limitations for patients with relapsed or refractory primary central nervous system lymphoma, a significant advancement based on positive clinical trial results from Dana-Farber Cancer Institute.
- Safety Data Emphasis: The updated label highlights Yescarta's robust safety profile in patients with relapsed or refractory CNS lymphoma, where 85% experienced neurologic toxicities, yet the FDA deemed the risks manageable, underscoring Yescarta's unique position in this treatment landscape.
- Urgent Market Need: With a five-year survival rate of only 30% for primary CNS lymphoma and over half of patients relapsing after initial treatment, the FDA's decision provides much-needed new treatment options, addressing the urgent demand for effective therapies in this underserved market.
- Clinical Study Results: In the Phase 1 study, 18 patients were enrolled, with 13 having relapsed or refractory CNS lymphoma, demonstrating Yescarta's safety and efficacy, thus providing clinicians with critical evidence to support its clinical application and broaden patient access.

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