Treatment with repotrectinib in patients with ROS1-positive non–small cell lung cancer (NSCLC) demonstrates anti-cancer activity according to updated results from the early phase TRIDENT-1 clinical trial presented at the 2023 World Conference on Lung Cancer. Based on the trial results the FDA accepted the new drug application for repotrectinib to treat patients with ROS1-positive, locally advanced or metastatic NSCLC and granted approval in November, 2023.2,3
All patients with lung cancer should undergo genomic biomarker testing at the time of diagnosis in order to determine if they have a mutation that can be treated with a precision cancer medicine, are eligible for participation in a clinical trial evaluating newer precision cancer medicines or undergo surveillance with sequential liquid biopsies to assess the effectiveness of treatment – the effectiveness of treatment can be monitored by following cancer specific DNA in the blood.
Importance of NGS-Biomarker Testing in NSCLC
About Augtyro (repotrectinib)
Repotrectinib is a precision cancer medicine that targets solid tumors that harbor ROS 1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Repotrectinib is designed to cross the blood-brain barrier, and preclinical studies show that the agent achieves high CNS concentrations.
The TRIDENT-1 clinical trial evaluated the safety, tolerability, and anti-tumor activity of repotrectinib as treatment for patients with advanced solid tumors.2 To be eligible for the phase trial, patients had to have locally advanced or metastatic solid tumors harboring ROS1 or NTRK1-3 gene fusions; asymptomatic central nervous system metastases were allowed. Both TKI-naïve and individuals who were previously treated were allowed in the study.
After a median follow-up of 24 months 79% of patients who had not previously been treated with a TKI had a median duration of response of 34 months. The 12, and 18-month survival rates without cancer progression were 77% and 70%, respectively and 88% of patients survived greater than 18-months.
In the patients who previously received 1 TKI the overall response rate was 38% with a median response duration of 15 months. Intracranial response rates were similar to the overall response rates. The most common side effect was dizziness, but this did not result in discontinuation of treatment. These results led to US Food and Drug Administration approval.
Connect With Others for Support and information
CancerConnect was the first social network created for people with lung cancer. Founded by oncologists to support cancer patients and their caregivers, over 40 million individuals have accessed CancerConnect programs since 1997. CancerConnect is used by leading cancer centers like Dana Farber, Roswell Park and The James at Ohio State to support their patients. Join the conversation, ask questions, share your experience, and learn how the best cancer centers are treating cancer from others. Share your experience, ask a question, or start a conversation by posting on CancerConnect.
References
- Cho BC, Camidge DR, Lin JJ, et al. Repotrectinib in patients with ROS1 fusion-positive (ROS1+) NSCLC: Update from the pivotal phase 1/2 TRIDENT-1 trial. Presented at: 2023 World Conference on Lung Cancer; September 10-12, 2023; Singapore. Abstract OA03.06.
- Repotrectinib continued to demonstrate high response rates and durable responses, including robust intracranial responses, in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer who were TKI-naïve or previously treated with one TKI and no chemotherapy. News Release. Bristol Myers Squibb. August 16, 2023. Accessed September 10, 2023. https://bit.ly/44QZ6u6
- US Food and Drug Administration approves Augtyro™ (repotrectinib), a next-generation Tyrosine Kinase Inhibitor (TKI), for the treatment of Locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). News release. Bristol Myers Squibb. November 15, 2023. Accessed November 15, 2023. https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Approves-Augtyro-repotrectinib-a-Next-Generation-Tyrosine-Kinase-Inhibitor-TKI-for-the-Treatment-of-Locally-Advanced-or-Metastatic-ROS1-Positive-Non-Small-Cell-Lung-Cancer-NSCLC/default.aspx
