Bristol Myers' Investigational Lung Cancer Candidate Shows High Response Rates

Bristol Myers Squibb & Co BMY announced updated results from a TRIDENT-1 study, demonstrating that repotrectinib — a next-generation ROS1/TRK tyrosine kinase inhibitor (TKI) — continued to show high response rates and durable responses in patients with metastatic non-small cell lung cancer.

Updated results will be featured in an oral presentation at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.

Based on results from the TRIDENT-1 trial, the U.S. Food and Drug Administration accepted the New Drug Application for repotrectinib for patients with ROS1-positive locally advanced or metastatic NSCLC and granted Priority Review; a Prescription Drug User Fee Act goal date of Nov. 27 was assigned.

In TKI-naïve patients (n=71) with a median follow-up of 24.0 months, the confirmed objective response rate (cORR) by Blinded Independent Central Review (BICR) was 79%, median DOR, and PFS were 34.1 months and 35.7 months, respectively. 

In patients with measurable brain metastases at baseline (n=9), intracranial ORR per BICR was 89%, and responses were prolonged.

In patients previously treated with one TKI and no chemotherapy (n=56) with a median follow-up of 21.5 months, cORR by BICR was 38%, and median DOR and PFS were 14.8 months and nine months, respectively. 

In this subset of patients with measurable brain metastases at baseline (n=13), intracranial ORR per BICR was 38%.

At the recommended dose for Phase 2, the safety profile of repotrectinib was manageable and remained consistent with previous reports.

The study remains ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors. 

Price Action: BMY shares are down 0.7% at $61.32 on the last check Wednesday.