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Turning Point Therapeutics' NDA Submission for Repotrectinib in Sight Based on Registrational Data

NEW YORK – Turning Point Therapeutics said on Tuesday that it will soon meet with the FDA to discuss its new drug application plans for repotrectinib based on positive results from the registrational TRIDENT-1 trial in ROS1-positive, advanced non-small cell lung cancer patients.

Based on a blind independent central review of the pooled analysis of 71 tyrosine kinase inhibitor (TKI)-naïve NSCLC patients in the Phase I and Phase II portions of the trial, 79 percent responded to repotrectinib. At a median follow-up of 10.2 months, the duration of response was between 1.4 months to 35.1 months and progression-free survival ranged from zero to 40.4 months.

In those who received one prior TKI and platinum-based chemotherapy, 11 out of 26 patients, or 42 percent, responded to repotrectinib. Meanwhile, five out of 18, or 28 percent, of patients on two prior TKIs, and 20 out of 56 patients, or 36 percent, on one prior TKI and no chemo responded to repotrectinib. Lastly, 10 out of 17 patients, or 59 percent, previously on a TKI and harboring a ROS1 G2032R solvent front mutation responded to Turning Point's drug.

"We … continue to believe repotrectinib is a potentially best-in-class drug candidate for patients with ROS1-positive advanced NSCLC," Turning Point CEO Athena Countouriotis said in a statement. "We believe a differentiated profile is built upon a strong objective response rate and durability of response that could improve upon the current standard of care."

ROS1-positive advanced NSCLC patients have a number of targeted treatment options including Pfizer's Xalkori (crizotinib) and Genentech's Rozlytrek (entrectinib).

Turning Point said it will discuss this data with the FDA at a pre-NDA meeting this quarter. The firm will also present detailed study results, including data on repotrectinib's intracranial activity in TRIDENT-1, at a medical conference in the second half of the year.