Repotrectinib monotherapy resulted in high objective response rates (ORR) in a cohort of patients with advanced ROS1 fusion-positive non-small cell lung cancer (NSCLC), according to updated results from the phase 2 expansion 1 (EXP-1) cohort of the  TRIDENT-1 study. The data were presented at the 2020 World Conference on Lung Cancer in Singapore.

“Preliminary TRIDENT-1 data support repotrectinib as a potential best-in-class treatment in ROS1-positive advanced NSCLC,” said lead author Byuong Chul Cho, MD, PhD, who presented the findings.

In the phase 1/2 TRIDENT-1 study (NCT03093116), investigators administered repotrectinib to patients with advanced ROS1-positive NSCLC across 4 cohorts. Previously reported phase 1 data demonstrated an ORR of 91% and a median duration of response (DOR) of 23.1 months with the monotherapy. The updated analysis included 15 patients who received the phase 2 dose of repotrectinib.

At baseline, the median patient age was 58 years and 60% of patients had an Eastern Cooperative Oncology Group performance status of 1. Twenty percent of the cohort received prior chemotherapy.


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At the data cutoff of December 31, 2020, the confirmed ORR was 93% (95% CI, 68-100), which included 1 unconfirmed partial response (PR). A second post-baseline scan is awaited to confirm the PR.

Repotrectinib was found to be well-tolerated. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2 in nature, and the most common TRAEs were dizziness (58.4%, all grades) and dysgeusia (43.2%, all grades). There were no grade 5 TEAEs. TEAEs led to the discontinuation of the study drug among 8.6% of patients; 17.8% required a dose reduction.

On December 8, 2020, Turning Point Therapeutics Inc., repotrectinib’s developer, announced that the U.S. Food and Drug Administration had granted the agent a breakthrough therapy designation for patients with metastatic, ROS1-positive NSCLC who had not received prior tyrosine kinase inhibitor therapy.

The “updated phase 2 data continues to support strong clinical activity in TKI-naïve patients,” Cho concluded.

Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.

Reference

Cho BC, Doebele RC, Lin JJ, et al. Phase 1/2 TRIDENT-1 study of repotrectinib in patients with ROS1+ or NTRK+ advanced solid tumors. Presented at: 2020 World Conference on Lung Cancer Singapore; January 28-31, 2020. Abstract MA11.07.

This article originally appeared on Cancer Therapy Advisor