FDA approves Augtyro for treatment of certain patients with non-small cell lung cancer
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The FDA approved repotrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Repotrectinib (Augtyro, Bristol Myers Squibb) is a next-generation tyrosine kinase inhibitor designed to target ROS1 oncogenic fusions. The agent was previously granted fast track designation and review by the FDA.
“While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” Samit Hirawat, MD, executive vice president and chief medical officer at Bristol Myers Squibb, said in a company-issued press release. “As the only approved next-generation TKI for ROS1-positive NSCLC patients, Augtyro builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”
FDA based approval on results from the multicenter phase 1/phase 2 TRIDENT-1 trial. The single-arm study evaluated the safety and efficacy of repotrectinib in adults with locally advanced or metastatic NSCLC whose tumors harbor ROS1 gene fusions.
The trial included adults previously treated with TKIs (n = 56) and those who had not received previous TKIs (n = 71). Overall response rate served as the primary efficacy endpoint for the phase 2 portion of the trial.
Results from the TRIDENT-1 study showed an ORR of 79% (95% CI, 68-88) among TKI-naive patients, with a median duration of response of 34.1 months. Patients previously treated with a TKI had a reported ORR of 38% (95% CI, 25-52), with a median duration of response of 14.8 months.
The most common adverse events related to the use of repotrectinib included dizziness (63%), dysgeusia (48%), peripheral neuropathy (47%) and constipation (36%). Serious adverse events occurred in 33% of patients who received repotrectinib during the TRIDENT-1 study, the most common being pneumonia (5.7%), dyspnea (3.8%), pleural effusion (3.4%) and hypoxia (3%).
The agent’s prescribing label contains warnings about the possibility of central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures and embryo-fetal toxicity related to the use of repotrectinib.
“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital, said in the release. “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”
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