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Turning Point Therapeutics to Discuss Repotrectinib NSCLC Data With FDA

NEW YORK – Turning Point Therapeutics on Friday said it plans to discuss interim data from the Phase II portion of the TRIDENT-1 study of its investigational drug repotrectinib in ROS1-positive non-small cell lung cancer with the US Food and Drug Administration.

In the Phase I/II TRIDENT-1 trial, Turning Point is exploring the activity of repotrectinib in patients with advanced solid tumors characterized by ALK, ROS1, and NTRK1/2/3 rearrangements. In the Phase II cohort involving tyrosine kinase inhibitor-naive patients with ROS1-postive NSCLC, the objective response rate was 93 percent among 15 enrolled patients, with one patient having a complete response.

The duration of response ranged from 1.3 months to 7.4 months. Researchers also found that repotrectinib was well tolerated based on data from 185 patients from the Phase I and Phase II portions.

There were 22 patients in the Phase I and Phase II portions of the study who received repotrectinib at the Phase II dose, and among them the objective response rate was 91 percent.

The latest response analysis, which was conducted after the last December 31 cutoff, showed an improved response rate compared to data presented in August, where 86 percent of participants had a confirmed objective response.

"To date, we have enrolled approximately 40 ROS1-positive TKI-naive patients in the Phase I and II portions of the TRIDENT-1 study dosed at or above the Phase II dose — an encouraging increase in enrollment following our data update from last August — and we look forward to discussing next steps towards registration of repotrectinib in this patient population at a Type B meeting with the FDA anticipated in the first half of the year," Mohammad Hirmand, Turning Point's chief medical officer, said in a statement.

The company is presenting the updated data from TRIDENT-1 at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer starting on Friday.

Turning Point is also conducting preclinical studies of repotrectinib in combination with other drugs to increase the effectiveness of KRAS-G12C and MEK inhibitors.