Repotrectinib in NTRK fusion–positive advanced solid tumors: a phase 1/2 trial

Abstract Early-generation TRK tyrosine kinase inhibitors (TKIs) approved for treating NTRK fusion–positive ( NTRK + ) solid tumors provide clinical benefit; however, resistance emerges. Repotrectinib is a next-generation ROS1/TRK TKI with a compact macrocyclic structure designed to improve durability of response. TRIDENT-1 is a registrational phase 1/2 trial assessing repotrectinib, a next-generation ROS1/TRK TKI, in adults with advanced solid tumors, including NTRK + disease. The primary endpoint was confirmed objective response; secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival and safety. Median follow-up ranged between 21.3 months and 25.7 months. In…

• BS
  Bristol-Myers Squibb
• NI
  National Institutes of Health

  Awards: 1R01CA251591001A1, P30CA008748, 1R01CA273224, 1R01CA273224-01
• NC
  National Cancer Institute

  Awards: P30CA008748, 1R01CA251591001A1, 1R01CA273224-01