Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People with NTRK Fusion-Positive Solid Tumors

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today 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.

“These data demonstrate the potential of entrectinib to treat a range of difficult-to-treat and rare cancers regardless of their site of origin,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Entrectinib has the potential to redefine personalized medicine, which can utilize tests such as next-generation sequencing to find the right treatment for each individual patient. People with NTRK fusion-positive solid tumors need more options, and we look forward to working with health authorities to bring this potential treatment to patients as soon as possible.”

Genentech is leveraging its expertise in developing personalized medicines and advanced diagnostics, in conjunction with Foundation Medicine, to develop a novel diagnostics approach using next-generation sequencing that will help identify people with NTRK gene fusions likely to benefit from entrectinib.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) 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.