On April 27, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported a comprehensive program update on entrectinib – an investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions – currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2 (Press release, Ignyta, APR 27, 2017, View Source [SID1234518716]). Schedule your 30 min Free 1stOncology Demo! "Today’s update is the result of our team’s diligent efforts to advance entrectinib through the clinic for the benefit of patients with TRK and ROS1 fusion-positive cancers," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We are proud to announce substantial progress towards dual entrectinib NDA submissions for both TRK and ROS1, and are excited by the opportunity to serve two distinct groups of patients with cancer."
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Entrectinib development highlights:
TRK –
Based on written feedback from FDA, Ignyta intends to pursue an NDA submission for entrectinib to support a TRK fusion-positive, tissue agnostic indication.
Ignyta’s entrectinib program is more than 85% enrolled to goal for the primary efficacy analysis for a TRK tissue agnostic NDA submission, and is on track to complete enrollment by the 3rd quarter of 2017.
Within STARTRK-2, several dozens of patients with TRK fusions have been enrolled, across more than 15 different tumor types; and investigators in approximately a dozen different countries on four continents currently have experience treating patients with entrectinib.
Ignyta plans to announce top-line NDA registration-enabling data from STARTRK-2, after consultation with FDA, in the first half of 2018.
ROS1 –
Ignyta is simultaneously pursuing an NDA submission for entrectinib to support a ROS1 fusion-positive NSCLC indication.
More than 50 ROS1 fusion-positive NSCLC patients have been enrolled to support a potential ROS1 NSCLC NDA for entrectinib, greater than the number that formed the basis of crizotinib’s approval in this setting.
Ignyta reported interim data from 32 patients with ROS1 fusion-positive NSCLC, including new patients from STARTRK-2 who were enrolled as of December 16, 2016.
24 out of the 32 patients had confirmed RECIST responses, for an objective response rate (ORR) of 75%.
The median duration of response (DOR) was 17.2 months among the responder patients, and the median progression free survival (PFS) was 19.1 months among all patients.
11 out of the 32 patients, or 34%, had CNS metastases at baseline.
Of these 11 patients with CNS disease, 7 had confirmed RECIST responses, for an ORR of 64% in ROS1 NSCLC patients with CNS metastases.
When aggregated with Ignyta’s Phase 1 data set of patients with primary and secondary CNS disease, a total of 10 out of 16 patients had confirmed RECIST responses, for an ORR of 63% in TRK, ROS1 or ALK patients with CNS disease.
Entrectinib commercial highlights:
Based upon analysis of more than 120,000 cancer patient samples from internal and external sources, Ignyta believes that in the US each year there are approximately 1,000-2,000 new patients with TRK fusion-positive advanced solid tumors, and 2,000 new patients with ROS1 fusion-positive NSCLC.
Entrectinib is simultaneously tracking towards TRK tissue agnostic NDA and ROS1 NSCLC NDA submissions in 2018, with anticipated US launch in 2019.
Based upon these dual indications, Ignyta believes the total addressable market for entrectinib could be in excess of $1B annually in the US alone.
A conference call and webcast is being held on April 27, 2017 at 4:30 p.m. Eastern/1:30 p.m. Pacific to discuss the entrectinib program update. To participate in the conference call, please dial (877) 548-7906 (U.S.) or (719) 325-4765 (International) and provide Conference ID 2028635. To access the live webcast, go to View Source." target="_blank" title="View Source." rel="nofollow">View Source
A replay of the presentation will be available shortly after the conclusion of the live call in the Investors section of the company’s website at View Source, and will be archived and available at that site for 14 days.