Genentech Announces Results From Integrated Analysis Of Phase II STARTRK-2

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), 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 (objective response rate; ORR) in more than half (57.4 percent) of people with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive solid tumors.

Objective responses to entrectinib were seen across 10 different solid tumor types (median duration of response [DoR] = 10.4 months), including in people with and without central nervous system (CNS) metastases at baseline. Importantly, entrectinib shrank tumors that had spread to the brain in over half of people (intracranial response; IC ORR=54.5 percent), 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.

Genentech also recently presented positive results at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) that showed entrectinib shrank tumors (ORR) in 77.4 percent of people with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). In addition, entrectinib demonstrated a durable response of more than two years (DoR = 24.6 months). Importantly, entrectinib was shown to shrink tumors in more than half of people with cancer in the CNS (IC ORR: 55.0 percent). The safety profile of entrectinib was consistent with that seen in previous analyses.

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.