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Roche's Rozlytrek Garners Conditional Authorization in Europe for Cancers With NTRK, ROS1 Fusions

NEW YORK – Roche said on Monday that the European Commission granted conditional marketing authorization to entrectinib (Rozlytrek) for patients with advanced, metastatic, or unresectable NTRK fusion-positive solid cancers, who have not been previously treated with an NTRK inhibitor and have no other treatment options. The EC also conditionally authorized entrectinib for ROS1-positive, advanced non-small cell lung cancer patients who have not received other ROS1 inhibitors.

The US Food and Drug Administration approved entrectinib in these same two indications last year.

Roche said it is developing a companion diagnostic that will identify patients who harbor NTRK and ROS1 gene fusions. Roche subsidiary Foundation Medicine markets the next-generation sequencing panel FoundationOne CDx, which can detect rearrangements in NTRK and ROS1.

The EC made its decision based on the combined data from the Phase II STARTRK-2 trial, the Phase I STARTRK-1 trial, the Phase I ALKA-373-001 trial, and the Phase I/II STARTRK-NG trial. The data showed that entrectinib produced durable responses in patients with NTRK fusion-positive solid tumors, including sarcoma, NSCLC, salivary mammary analogue secretory carcinoma, secretory and non-secretory breast cancer, thyroid cancer, colorectal cancer, neuroendocrine cancer, pancreatic cancer, ovarian cancer, endometrial cancer, cholangiocarcinoma, gastrointestinal cancer, and neuroblastoma.

Across 74 patients spanning 14 tumor types, entrectinib had an overall response rate of 63.5 percent, with a median duration of response of 12.9 months.

Additionally, entrectinib shrank tumors in 73.4 percent of the 94 patients with ROS1-positive NSCLC. The median duration of response in this population was 16.5 months.

Entrectinib also showed efficacy in patients with brain metastases. NTRK fusion-positive patients with central nervous system metastases at baseline had an overall response rate of 62.5 percent and ROS1-positive NSCLC patients with CNS metastases at baseline had an overall response of 77.8 percent.

In the five NTRK fusion-positive pediatric patients who participated in the trials, entrectinib shrank tumors in all patients. Two patients achieved a complete response.