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Cited by 240Lung Cancer Treatments and MutationsLung Cancer Research StudiesLung Cancer Diagnosis and Treatment

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

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Drilon, Alexander, Camidge, D. Ross, Lin, Jessica J., Kim, Sang-We, Solomon, Benjamin J., Dziadziuszko, Rafal, Besse, Benjamin, Goto, Koichi, de Langen, Adrianus Johannes, Wolf, Jürgen, Lee, Ki Hyeong, Popat, Sanjay, Springfeld, Christoph, Nagasaka, Misako, Felip, Enriqueta, Yang, Nong, Velcheti, Vamsidhar, Lu, Shun, Kao, Steven, Dooms, Christophe, Krebs, Matthew G., Yao, Wenxiu, Beg, Muhammad Shaalan, Hu, Xiufeng, Moro-Sibilot, Denis, Cheema, Parneet, Stopatschinskaja, Shanna, Mehta, Minal, Trone, Denise, Graber, Armin, Sims, Gregory, Yuan, Yong, Cho, Byoung Chul·2024·New England Journal of Medicine
DOI 10.1056/nejmoa2302299PMC PMC11702311
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Abstract

The early-generation ROS1 tyrosine kinase inhibitors (TKIs) that are approved for the treatment of ROS1 fusion–positive non–small-cell lung cancer (NSCLC) have antitumor activity, but resistance develops in tumors, and intracranial activity is suboptimal. Repotrectinib is a next-generation ROS1 TKI with preclinical activity against ROS1 fusion–positive cancers, including those with resistance mutations such as ROS1 G2032R. Download a PDF of the Research Summary. In this registrational phase 1–2 trial, we assessed the efficacy and safety of repotrectinib in patients with advanced solid tumors, including ROS1 fusion–positive NSCLC. The primary efficacy end point in the phase 2 trial was confirmed objective response; efficacy analyses included patients from phase 1 and phase 2. Duration of response, progression-free survival, and safety were secondary end points in phase 2. On the basis of results from the phase 1 trial, the recommended phase 2 dose of repotrectinib was 160 mg daily for 14 days, followed by 160 mg twice daily. Response occurred in 56 of the 71 patients (79%; 95% confidence interval [CI], 68 to 88) with ROS1 fusion–positive NSCLC who had not previously received a ROS1 TKI; the median duration of response was 34.1 months (95% CI, 25.6 to could not be estimated), and median progression-free survival was 35.7 months (95% CI, 27.4 to could not be estimated). Response occurred in 21 of the 56 patients (38%; 95% CI, 25 to 52) with ROS1 fusion–positive NSCLC who had previously received one ROS1 TKI and had never received chemotherapy; the median duration of response was 14.8 months (95% CI, 7.6 to could not be estimated), and median progression-free survival was 9.0 months (95% CI, 6.8 to 19.6). Ten of the 17 patients (59%; 95% CI, 33 to 82) with the ROS1 G2032R mutation had a response. A total of 426 patients received the phase 2 dose; the most common treatment-related adverse events were dizziness (in 58% of the patients), dysgeusia (in 50%), and paresthesia (in 30%), and 3% discontinued repotrectinib owing to treatment-related adverse events. Repotrectinib had durable clinical activity in patients with ROS1 fusion–positive NSCLC, regardless of whether they had previously received a ROS1 TKI. Adverse events were mainly of low grade and compatible with long-term administration. (Funded by Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb; TRIDENT-1 ClinicalTrials.gov number, NCT03093116.) QUICK TAKE VIDEO SUMMARYRepotrectinib in ROS1 Fusion–Positive Lung Cancer 02:17

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  1. Li W Yang N Li K et al. Updated efficacy and safety of taletrectinib in patients with ROS1 non small cell lung cancer. In: Proceedings and abstracts of the 2023 European Lung Cancer Congress March 29–April 1 2023. Copenhagen: European Society for Medical Oncology 2023.

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Metadata

Authors
Drilon, A., Camidge, D. R., Lin, J. J., Kim, S.-W., Solomon, B. J., Dziadziuszko, R., Besse, B., Goto, K., de Langen, A. J., Wolf, J., Lee, K. H., Popat, S., Springfeld, C., Nagasaka, M., Felip, E., Yang, N., Velcheti, V., Lu, S., Kao, S., Dooms, C., Krebs, M. G., Yao, W., Beg, M. S., Hu, X., Moro-Sibilot, D., Cheema, P., Stopatschinskaja, S., Mehta, M., Trone, D., Graber, A., Sims, G., Yuan, Y., & Cho, B. C.
Affiliations
  • Memorial Sloan Kettering Cancer Center (US)
  • From 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, Am...
  • Royal Marsden NHS Foundation Trust (GB)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2024-01-11
Volume
390
Issue
2
Pages
118-131
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2302299
PMC
PMC11702311
OpenAlex
W4390690905
Cited by
240
References
19
Citations by year
2026: 94 · 2025: 91 · 2024: 54
FWCI
69.02
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
  • Research Explorer (The University of Manchester) (submittedVersion, other-oa)
  • Lirias (KU Leuven) (submittedVersion)
Funders
  • Manchester Biomedical Research Centre
  • National Cancer Institute (1R01CA273224-01, P30 CA008748)
  • Bristol-Myers Squibb
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords
repotrectinib, ROS1 rearrangement, non-small cell lung cancer, ROS1 tyrosine kinase inhibitors, acquired resistance, intracranial activity, progression-free survival, objective response rate, treatment-related adverse events, advanced solid tumors, recommended phase 2 dose, duration of response, dizziness
MeSH terms
Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Pyrazoles, Treatment Outcome, Macrocyclic Compounds

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