Colorectal Cancer
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Zanzalintinib Plus Immune Checkpoint Inhibitor Shows Promise in Metastatic Colorectal Cancer: Detailed Results from the STELLAR-303 Trial, Presented at ESMO 2025 and Published in The Lancet
The STELLAR-303 phase 3 trial evaluated zanzalintinib plus atezolizumab versus regorafenib in previously treated metastatic colorectal cancer. The combination significantly improved median overall survival (10.9 vs. 9.4 months) and reduced the risk of death by 20% in the ITT population. Consistent benefits were observed across subgroups. Exelixis plans to submit a new drug application for zanzalintinib in the U.S. in 2025, potentially offering a new chemotherapy-free option for patients. The safety profile was consistent with prior observations.
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Incyte Reports Phase 1 Data on TGFβR2×PD-1 Bispecific Antibody in Advanced CRC and KRAS G12D Inhibitor in Advanced PDAC
Incyte presented promising data at ESMO 2025 for INCA33890, a TGFβR2×PD-1 bispecific antibody, showing potential efficacy in microsatellite stable (MSS) colorectal cancer with a manageable safety profile. A registrational program is planned for 2026. Also, INCB161734, a KRAS G12D inhibitor, demonstrated a favorable safety profile and clinical benefit in heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients. Further development plans for INCB161734 are under evaluation.
