GENFIT: Positive Phase 1b Data with GNS561 in Combination Therapy in Heavily Pretreated Patients with Cholangiocarcinoma

GENFIT announced positive Phase 1b results for GNS561, an investigational drug targeting autophagy, in combination with a MEK inhibitor for treating advanced KRAS-mutated cholangiocarcinoma. The study of 19 patients showed a favorable safety profile with no dose-limiting toxicities and early signs of antitumor activity, with approximately half achieving stable disease. Phase 2 initiation is planned for the second half of 2026.