Tempest Therapeutics Advances Liver Cancer Program with Roche Collaboration and FDA Agreement
• Tempest Therapeutics has secured a drug supply agreement with Roche for its Phase 3 study in first-line Hepatocellular Carcinoma (1L HCC).
• The FDA has agreed to Tempest's Phase 3 study plan, including dosing and overall survival (OS) as the primary endpoint, potentially shortening the timeline with an early efficacy analysis.
• Tempest Therapeutics estimates the Phase 3 study will cost around $100 million, but the Roche agreement is expected to reduce expenses by $30-50 million.
• Despite positive clinical advancements, Tempest Therapeutics acknowledges the need for significant funding to support the Phase 3 study.
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