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

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机构： [1]Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College,New York [2]the NYU Perlmutter Cancer Center,New York [3]the University of Colorado, Anschutz Medical Campus, Aurora [4]Massachusetts General Hospital, Harvard Medical School, Boston [5]Asan Medical Center,Seoul [6]Yonsei Cancer Center, Yonsei University College of Medicine,Seoul [7]Chungbuk National University Hospital, Cheongju-si,South Korea [8]Peter MacCallum Cancer Center, Melbourne, VIC [9]the Chris O’Brien Lifehouse, Camperdown, NSW [10]Department of Oncology and Radiotherapy and Early Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland [11]Paris-Saclay University, Gustave Roussy Cancer Center, Villejuif [12]Centre Hospitalier Universitaire de Grenoble–Alpes, La Tronche [13]National Cancer Center Hospital East, Kashiwa, Japan [14]Netherlands Cancer Institute, Amsterdam [15]Center for Integrated Oncology, University Hospital of Cologne, Cologne [16]the Department of Medical Oncology, Heidelberg University Hospital, National Center for Tumor Diseases, Heidelberg [17]Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London [18]the University of Manchester and the Christie NHS Foundation Trust, Manchester [19]the University of California, Irvine, School of Medicine, Orange [20]Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb, San Diego [21]Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona [22]Hunan Cancer Hospital, Hunan [23]Department of Oncology, Shanghai Chest Hospital, Shanghai [24]Sichuan Cancer Hospital and Institute, Chengdu [25]Henan Cancer Hospital, Zhengzhou [26]the Respiratory Oncology Unit, University Hospitals Leuven, Leuven, Belgium [27]UT Southwestern Medical Center, Dallas [28]William Osler Health System, University of Toronto, Toronto [29]Bristol Myers Squibb, Princeton, NJ

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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.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.).Copyright © 2024 Massachusetts Medical Society.

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大类 | 1 区

医学

小类 | 1 区医学：内科

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Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 96.3 最新[2023版] 94.3 最新五年平均 96.3 出版当年[2023版] 0 出版当年五年平均 96.3 出版前一年[2023版]

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第一作者机构： [1]Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College,New York

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