Rare Disease Report

New Data Shows Potential of Entrectinib in NSCLC

OCTOBER 18, 2017
Mathew Shanley
This morning at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohoma, Japan, Ignyta announced results from a study of entrectinib in patients with ROS1-positive non-small cell lung cancer (NSCLC).

The newly-released data from the STARTRK-2 trial of entrectinib confirmed that patients administered the drug demonstrated a 78% confirmed overall response rate (ORR) by Investigator and a 69% ORR by Blinded Independent Central Review in 32 patients with locally advanced or metastatic NSCLC.

The STARTRK-2 study is an open-label, multicenter, global Phase 2 with a basket design that screens patient tumor samples for the relevant targets in an attempt to take advantage of the drug’s confirmed preliminary clinical activity across an array of tumor types and molecular targets.

Across 3 different studies (ALKA, STARTRK-1 and STARTRK-2), Ignyta has treated a total of more than 70 ROS1 fusion-positive NSCLC subjects with entrectinib across 3 studies, making it one of the largest clinical datasets evaluating efficacy in this patient population.

"Based on these data, we believe that entrectinib has the potential to be a best-in-class therapeutic option as a first-line targeted therapy for patients with ROS1-positive NSCLC,” said Jonathan Lim, M.D., chairman and CEO of Ignyta in a press release. “The extended duration of response and progression free survival times observed in these interim data are particularly compelling, and we believe may be driven by entrectinib’s CNS activity. Entrectinib was designed to cross the blood-brain barrier, allowing it to both address preexisting CNS lesions and have the potential to prevent or delay the onset of metastases to the brain, a common site of progression, particularly in NSCLC.”

Studies evaluating the safety of entrectinib have exhibited consistent data, with more than 200 patients treated at the recommended phase 2 dose and most adverse events (AEs) being Grade 1-2 and reversible. The most common Grade 3 treatment-related AEs were increased weight, anemia and fatigue, and there have been no Grade 4 vents occurring in more than 1% of patients and absolutely no Grade 5 events.

“ROS1 fusions occur in approximately two percent of all cases of NSCLC and, given the propensity for these tumors to metastasize to the brain, the CNS activity of entrectinib is a critical differentiating feature of the compound and may be contributing to the impressive duration and progression free survival it has demonstrated thus far,” said study author Myung-Ju Ahn, Professor in the Department of Hematology and Oncology at the Samsung Medical Center in Seoul Korea.

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