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PMID
Authors B.J. Solomon A. Drilon J.J. Lin L. Bazhenova K. Goto J. De Langen D-W. Kim J. Wolf C. Springfeld S. Popat D.W-T. Lim C.S. Baik A. Hervieu V. Moreno Garcia N. Yang S. Thamake F. Ades D. Trone B. Besse
Title 1372P Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase I/II TRIDENT-1 trial
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 34 Suppl 2 Oct 2023 S787-S788 Ann Oncol
URL https://www.annalsofoncology.org/article/S0923-7534(23)03242-8/fulltext
Abstract Text Background Repotrectinib, a next-generation ROS1 and TRK tyrosine kinase inhibitor (TKI), has shown clinical activity and manageable safety in pts with ROS1+ NSCLC or NTRK+ locally advanced/metastatic solid tumors in the pivotal phase 1/2 TRIDENT-1 trial (NCT03093116). This is the first report of repotrectinib efficacy by Blinded Independent Central Review (BICR), with 8.7 mo minimum follow-up in pts with TKI-naïve and -pretreated NTRK+ solid tumors, including NSCLC, and safety in all pts treated at the recommended phase 2 dose (RP2D). Methods. Pts with NTRK+ solid tumors were enrolled in TKI-naïve and -pretreated cohorts. RP2D was 160 mg QD for 14 d, then 160 mg BID. Phase 2 primary endpoint: confirmed objective response rate (cORR) by BICR. Results At data cutoff (19 Dec 2022), median follow-up was 17.8 mo (range, 8.7–64.6) in the TKI-naïve cohort (n = 40), and 20.1 mo (8.7–69.4) in the TKI-pretreated cohort (n = 48). The table shows efficacy in pts with NTRK+ solid tumors and subgroups of interest. NSCLC was the most common tumor (TKI-naïve, 52%; TKI-pretreated, 29%). In TKI-naïve NTRK+ NSCLC, cORR was 62% (95% CI, 38–82) and estimated 12-mo duration of response (DOR) and progression-free survival (PFS) was 92% (95% CI, 76–100) and 64% (43–86), respectively. In TKI-pretreated NTRK+ NSCLC, cORR was 42% (18–71) and estimated 12-mo DOR and PFS was 44% (1–88) and 23% (0–49), respectively. In all pts treated at RP2D in TRIDENT-1 (n = 426), dizziness (62%; grade ≥3, 3%) was the most common treatment-emergent adverse event (TEAE). Grade ≥3 TEAEs occurred in 51% of pts (29% treatment-related AEs). Treatment discontinuation rate due to TEAEs was 7% (3% due to treatment-related AEs). Conclusions In TRIDENT-1, with 8.7 mo minimum follow-up, repotrectinib showed robust responses and durable clinical activity in both TKI-naïve and -pretreated pts with NTRK+ solid tumors, including NSCLC. Repotrectinib safety at RP2D was manageable, consistent with prior reports.

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