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Gritstone bio Announces Interim Phase 2 Data for GRANITE Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer
Gritstone bio announced encouraging interim Phase 2 data for GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC).
The study showed a 21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79). In the low ctDNA subgroup, there was a 38% relative risk reduction (HR=0.62). The strength of neoantigen-specific T cell responses in GRANITE patients appears to associate with progression-free survival. GRANITE was generally well-tolerated with no treatment discontinuations due to adverse events. Overall survival data is expected in 2H 2025.
The study included 104 randomized patients, with 69 in the treated analysis. GRANITE demonstrated a favorable safety profile, with common adverse events being mild systemic and local effects associated with potent vaccines.
Gritstone plans to review the PFS data with FDA and discuss next steps, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria
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