The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs鈥� (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC).
Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC.
The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib.
Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median DOR of 34.1 months. Repotrectinib鈥檚 safety profile is consistent with previous reports. The primary endpoint of this study was ORR.
Scheduled for a US market debut in mid-December, Augtyro will enter an already crowded NSCLC drug league dominated by a number of seasoned competitors. TKIs like 鈥檚 Lorbrena (lorlatinib) and Xalkori (crizotinib), and Roche鈥檚 Roxlytrek (entrectinib) are currently used to treat ROS1+ NSCLC.
Hot on the heels of these heavy hitters is ArriVent Biopharma, a clinical stage biopharmaceutical company, looking to introduce its own targeted treatment 鈥攆or exon 20 insertion mutations鈥攖hat received FDA breakthrough therapy designation in October.
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By GlobalDataData from TRIDENT-1 informed the FDA鈥檚 decision to give priority review to BMS鈥檚 new drug application (NDA) for repotrectinib back in May. In addition, China鈥檚 National Medical Products Administration Centre for Drug Evaluation awarded a breakthrough therapy designation to BMS for repotrectinib鈥檚 treatment of NTRK-positive advanced solid tumours in August.
