AUGTYROTM (repotrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Median follow-up for ORR data (primary endpoint): 18.1 months.6 Median follow-up for DOR data: 24.0 months.7
Durable response is based on objective response rate and median duration of response for AUGTYRO.1
CR, n=4/71; PR, n=52/71.6
AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Data from the TKI-naïve cohort of the pivotal TRIDENT-1 study, a Phase 1/2 multicenter, single-arm, open-label, multicohort clinical trial of AUGTYRO (160 mg orally once daily for 14 days, then increased to 160 mg twice daily until disease progression or unacceptable toxicity) in adult patients with locally advanced or metastatic ROS1+ NSCLC. The major efficacy outcome measures were ORR and DOR (assessed by BICR per RECIST v1.1). Efficacy population included patients who received at least 1 dose of AUGTYRO.1
BICR=blinded independent central review; CR=complete response; DOR=duration of response; mDOR=median duration of response; NE=not evaluable, endpoint not yet reached; NSCLC=non-small cell lung cancer; ORR=objective response rate; PR=partial response; RECIST=Response Evaluation Criteria In Solid Tumors; ROS1=proto-oncogene C-Ros1, receptor tyrosine kinase; TKI=tyrosine kinase inhibitor.