Ignyta (RXDX) reports positive data for Entrectinib

Ignyta reports data for Entrectinib demonstrated a 78% and 69% confirmed ORR

• Co announced updated results from its clinical trials, including the STARTRK-2 trial, of entrectinib - an investigational, CNS-active, potent, and selective tyrosine kinase inhibitor being developed for tumors that harbor NTRK fusions or ROS1 fusions.
• In this interim analysis, entrectinib demonstrated a 78% confirmed ORR and a 69% confirmed ORR in 32 patients with locally advanced or metastatic non-small cell lung cancer that harbored ROS1 fusions.
• Entrectinib demonstrated compelling durability in these patients, with a median duration of response of 28.6 months and a median progression free survival of 29.6 months.
• Of the patients evaluated, 11 had CNS metastases at baseline as assessed by Investigator, and 83% of the patients with measurable CNS metastases at presentation had confirmed intracranial RECIST responses to treatment with entrectinib.
• Based on recent guidance from the FDA, the company is on track for dual NDA submissions in both the NTRK tissue-agnostic and the ROS1-positive NSCLC indications in 2018.