Entrectinib shrank tumors in people with NTRK fusion-positive solid tumors
Genentech, a member of the Roche, announced results from an integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials that showed the investigational personalized medicine entrectinib shrank tumors in more than half of people with neurotrophic tropomyosin receptor kinase fusion-positive solid tumors. Objective responses to entrectinib were seen across 10 different solid tumor types, including in people with and without central nervous system metastases at baseline. Importantly, entrectinib shrank tumors that had spread to the brain in over half of people, with more than a quarter of these people having a complete response. The safety profile of entrectinib was consistent with that seen in previous analyses. Entrectinib has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. Genentech plans to submit results from these integrated analyses to global health authorities for the treatment of NTRK fusion-positive solid tumors and ROS1-positive NSCLC.