Define durability*

  • 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
  • Intracranial response according to modified RECIST v1.1 was assessed by BICR. Among 71 patients in the TKI-naïve cohort, 8 had measurable CNS metastases at baseline (as assessed by BICR). icORR is a secondary endpoint of the pivotal trial of AUGTYRO.1
  • The ROS1+ NSCLC safety population included 264 patients from the Phase 2 study cohort, who received the recommended dose of AUGTYRO.1

BICR=blinded independent central review; CNS=central nervous system; CR=complete response; DOR=duration of response; icORR=intracranial objective response rate; mDOR=median duration of response; mPFS=median progression-free survival; NE=not evaluable, endpoint not yet reached; NSCLC=non-small cell lung cancer; ORR=objective response rate; PFS=progression-free survival; PR=partial response; RECIST=Response Evaluation Criteria In Solid Tumors; ROS1=proto-oncogene C-Ros1, receptor tyrosine kinase; TKI=tyrosine kinase inhibitor.


1. AUGTYRO [package insert]. Princeton, NJ. Bristol-Myers Squibb Company. 2. Yun MR, Kim DH, Kim SY, et al. Repotrectinib exhibits potent antitumor activity in treatment-naïve and solvent-front-mutant ROS1-rearranged non-small cell lung cancer. Clin Cancer Res. 2020;26(13):3287-3295. 3. Murray BW, Rogers E, Zhai D, et al. Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and resistant mutations. Mol Cancer Ther. 2021;20(12):2446-2456. 4. Drilon A, Ou SI, Cho BC, et al. Repotrectinib (TPX-0005) is a next-generation ROS1/TRK/ALK inhibitor that potently inhibits ROS1/TRK/ALK solvent-front mutations. Cancer Discov. 2018;8(10):1227-1236. 5. Cho BC, Lin JJ, Camidge DR, et al. Pivotal topline data from the phase 1/2 TRIDENT-1 trial of repotrectinib in patients with ROS1+ advanced non-small cell lung cancer (NSCLC). Eur J Cancer. 2022;174(suppl1):S1–S2. 6. Cho BC, Camidge DR, Lin JJ, et al. Repotrectinib in patients with ROS1 fusion-positive non-small cell lung cancer: update from the pivotal phase 1/2 TRIDENT-1 trial. Presented at: 2023 World Conference on Lung Cancer; September 9-12, 2023; Singapore.

To learn more about a next-generation TKI for your patients with ROS1+ NSCLC,

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