GENFIT: Positive Phase 1b Data for GNS561 in Cholangiocarcinoma
GENFIT announced positive Phase 1b data for GNS561 in combination with a MEK inhibitor in patients with KRAS-mutated cholangiocarcinoma, previously treated with one or two standard treatment lines. The experimental drug showed a favorable safety and tolerance profile, with no reported dose-limiting toxicity, and initial signs of antitumor activity. The company plans to continue the study with additional cohorts at higher doses, while aiming for a Phase 2 entry in the second half of 2026.
Positive Clinical Signal in a Difficult-to-Treat Population
The Phase 1b study evaluates GNS561 in combination with trametinib, a MEK inhibitor, in patients with advanced KRAS-mutated cholangiocarcinoma. According to GENFIT, the first part of the study was conducted as planned, with 19 patients included in four cohorts of increasing doses. No cases of dose-limiting toxicity were observed. The company also notes that about half of the patients showed disease stabilization at the sixth week, including one patient with stabilization maintained until the thirtieth week. While these data remain preliminary, they support the continued clinical development of the program.
Phase 2 Still Targeted for the Second Half of 2026
GENFIT plans to expand Phase 1b with additional cohorts at higher dose levels to strengthen the clinical data set. According to the company, this extension does not alter the planned schedule for moving into Phase 2, still expected in the second half of 2026. The recommended dose for Phase 2 and the study design are to be finalized during the summer. At this stage, GNS561 remains an experimental drug: the translation of these initial clinical signals into regulatory approval or future revenues will depend on the next development steps.
GENFIT Also Continues the Deployment of NASHnext
This announcement follows the launch of NASHnext via Labcorp OnDemand, announced on June 8, 2026. This non-invasive diagnostic test, developed by Labcorp and based on GENFIT's proprietary NIS4 technology, aims to identify at-risk patients with MASH. GENFIT states that Labcorp OnDemand allows patients to access the test online in a pathway supervised by a healthcare professional, with blood sampling at a Labcorp center and consultation of results via the MyLabcorp app.
