On September 6, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that, based on recent FDA guidance, Ignyta has completed enrollment of the NDA registration efficacy data set of over 50 patients with ROS1 fusion-positive NSCLC for entrectinib, an orally bioavailable, CNS-active, tyrosine kinase inhibitor currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2 (Press release, Ignyta, SEP 6, 2017, View Source [SID1234520387]). In total, Ignyta has treated more than 70 ROS1 fusion-positive NSCLC patients with entrectinib across its ALKA, STARTRK-1, and STARTRK-2 studies. The U.S. Food and Drug Administration’s (FDA) most recent guidance confirmed that these studies will form the basis of a registrational dataset in ROS1 fusion-positive NSCLC; no additional studies were requested by FDA.

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"We are grateful that FDA provided clear feedback on the regulatory path for Ignyta’s planned submission for entrectinib for the treatment of patients with ROS1 fusion-positive non-small cell lung cancer," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "With this feedback in hand, we remain on track to submit an NDA filing in the ROS1 NSCLC indication in the second half of 2018, to achieve 12 months of follow-up on all responders in the registrational data set."
The latest interaction with FDA has clarified the regulatory pathway for entrectinib in ROS1 NSCLC:

• Written feedback from the FDA confirmed that the NDA submission for ROS1-positive NSCLC will be based on three single arm studies, including two Phase 1 studies, ALKA and STARTRK-1, and the Phase 2 STARTRK-2 basket trial. No additional studies or confirmatory data were requested.

• Objective response rate (ORR), as assessed by blinded independent central review, was confirmed as the primary endpoint. FDA requested that all responding patients be followed for 12 months to assess durability of response.

• Entrectinib was intentionally designed to cross the blood-brain barrier and has demonstrated CNS activity. Specific guidance was provided by FDA on inclusion of entrectinib CNS efficacy data in future prescribing information.
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Interim data from STARTRK-2 on entrectinib in ROS1 lung cancer were shared in an investor update call in April 2017. An update on these data, including an additional six months of follow-up, will be presented at an upcoming medical conference in the fourth quarter of 2017.
"In our upcoming data presentation, we will further illuminate characteristics of entrectinib that may meaningfully differentiate the therapy in the eyes of prescribers, including duration of response, progression-free survival, CNS activity, and ongoing tolerability, which becomes more critical for patients as duration of response increases," said Pratik S. Multani, M.D., Chief Medical Officer of Ignyta. "We hope these updated data, along with centrally reviewed response rates, will further enhance the already compelling profile of entrectinib and its potential in ROS1 NSCLC."