InxMed reports positive trial results for KRAS-mutant colorectal cancer

The phase Ib/II study evaluated the combination therapy across two cohorts. In the randomized portion, patients receiving both drugs achieved an objective response rate of 38.9%, compared to 16.7% for those treated with garsorasib alone. This regimen also extended median progression-free survival to 7.7 months against 4.0 months for the monotherapy group. Data indicated a consistent benefit, with median overall survival reaching 14.3 months in the single-arm study.

Safety profiles remained manageable throughout the trial, with no grade 4 adverse events or treatment-related deaths reported. While 97% of the 33 combination-therapy patients experienced some treatment-related adverse events, these were primarily grade 1 or 2, consisting mainly of diarrhea, proteinuria, and nausea. Researchers believe that inhibiting the FAK–YAP signaling pathway helps prevent the adaptive resistance typically triggered by KRAS G12C inhibitors, effectively sensitizing tumor cells to treatment.

Following these results, InxMed has submitted an Investigational New Drug application in China to initiate a phase III trial. The company intends to compare this combination against standard care to further validate its clinical utility. Ifebemtinib continues to be tested as a potential backbone therapy in various combinations for RAS-mutant cancers, aiming to provide a more convenient alternative to existing intravenous anti-EGFR antibody treatments.