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Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer.

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  • 1From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College (A.D.) and the NYU Perlmutter Cancer Center (V.V.) - all in New York; the University of Colorado, Anschutz Medical Campus, Aurora (D.R.C.); Massachusetts General Hospital, Harvard Medical School, Boston (J.J.L.); Asan Medical Center (S.-W.K.) and Yonsei Cancer Center, Yonsei University College of Medicine (B.C.C.), Seoul, and Chungbuk National University Hospital, Cheongju-si (K.H.L.) - all in South Korea; the Peter MacCallum Cancer Center, Melbourne, VIC (B.J.S.), and the Chris O'Brien Lifehouse, Camperdown, NSW (S.K.) - both in Australia; the Department of Oncology and Radiotherapy and Early Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland (R.D.); Paris-Saclay University, Gustave Roussy Cancer Center, Villejuif (B.B.), and Centre Hospitalier Universitaire de Grenoble-Alpes, La Tronche (D.M.-S.) - both in France; National Cancer Center Hospital East, Kashiwa, Japan (K.G.); the Netherlands Cancer Institute, Amsterdam (A.J.L.); the Center for Integrated Oncology, University Hospital of Cologne, Cologne (J.W.), and the Department of Medical Oncology, Heidelberg University Hospital, National Center for Tumor Diseases, Heidelberg (C.S.) - both in Germany; the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London (S.P.), and the University of Manchester and the Christie NHS Foundation Trust, Manchester (M.G.K.) - all in the United Kingdom; the University of California, Irvine, School of Medicine, Orange (M.N.), and Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb, San Diego (S.S., M.M., D.T., A.G., G.S.) - both in California; Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (E.F.); Hunan Cancer Hospital, Hunan (N.Y.), the Department of Oncology, Shanghai Chest Hospital, Shanghai (S.L.), Sichuan Cancer Hospital and Institute, Chengdu (W.Y.), and Henan Cancer Hospital, Zhengzhou (X.H.) - all in China; the Respiratory Oncology Unit, University Hospitals Leuven, Leuven, Belgium (C.D.); UT Southwestern Medical Center, Dallas (M.S.B.); William Osler Health System, University of Toronto, Toronto (P.C.); and Bristol Myers Squibb, Princeton, NJ (Y.Y.).

The New England Journal of Medicine
|January 10, 2024
PubMed
Summary

Repotrectinib shows durable clinical activity in ROS1 fusion-positive non-small-cell lung cancer (NSCLC), even with resistance mutations. This next-generation tyrosine kinase inhibitor (TKI) offers a promising treatment option for patients with advanced NSCLC.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Early-generation ROS1 tyrosine kinase inhibitors (TKIs) for ROS1 fusion-positive non-small-cell lung cancer (NSCLC) exhibit antitumor activity but face challenges with resistance and suboptimal intracranial efficacy.
  • Repotrectinib, a next-generation ROS1 TKI, demonstrates preclinical efficacy against ROS1-positive cancers, including those with resistance mutations like ROS1 G2032R.

Purpose of the Study:

  • To assess the efficacy and safety of repotrectinib in patients with advanced solid tumors, with a focus on ROS1 fusion-positive NSCLC.
  • To evaluate repotrectinib's performance in patients with and without prior ROS1 TKI treatment, including those with specific resistance mutations.

Main Methods:

  • A registrational phase 1-2 clinical trial involving patients with advanced solid tumors, including ROS1 fusion-positive NSCLC.
  • Primary efficacy endpoint: confirmed objective response. Secondary endpoints: duration of response, progression-free survival, and safety.
  • Efficacy analyses included data from both phase 1 and phase 2 of the trial.

Main Results:

  • In treatment-naïve ROS1-positive NSCLC patients, repotrectinib achieved a 79% objective response rate with a median duration of response of 34.1 months and median progression-free survival of 35.7 months.
  • In patients previously treated with one ROS1 TKI (and no chemotherapy), the objective response rate was 38%, with a median duration of response of 14.8 months and median progression-free survival of 9.0 months.
  • Among patients with the ROS1 G2032R mutation, 59% showed a response. Common adverse events included dizziness, dysgeusia, and paresthesia, with a low discontinuation rate due to treatment-related adverse events.

Conclusions:

  • Repotrectinib demonstrates durable clinical activity in patients with ROS1 fusion-positive NSCLC, irrespective of prior ROS1 TKI treatment history.
  • The adverse event profile of repotrectinib is generally low-grade and manageable, supporting its potential for long-term administration.
  • The study, TRIDENT-1 (NCT03093116), was funded by Turning Point Therapeutics.