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Safety and efficacy of pralsetinib in RET fusion–positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial : Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial
DC Field | Value | Language |
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dc.contributor.author | Griesinger, F. | - |
dc.contributor.author | Curigliano, G. | - |
dc.contributor.author | Thomas, M. | - |
dc.contributor.author | Subbiah, V. | - |
dc.contributor.author | Baik, C. S. | - |
dc.contributor.author | Tan, D. S. W. | - |
dc.contributor.author | Lee, D. H. | - |
dc.contributor.author | Misch, D. | - |
dc.contributor.author | Garralda, E. | - |
dc.contributor.author | Kim, Dong Wan | - |
dc.contributor.author | van der Wekken, A. J. | - |
dc.contributor.author | Gainor, J. F. | - |
dc.contributor.author | Paz-Ares, L. | - |
dc.contributor.author | Liu, S., V | - |
dc.contributor.author | Kalemkerian, G. P. | - |
dc.contributor.author | Houvras, Y. | - |
dc.contributor.author | Bowles, D. W. | - |
dc.contributor.author | Mansfield, A. S. | - |
dc.contributor.author | Lin, J. J. | - |
dc.contributor.author | Smoljanovic, V. | - |
dc.contributor.author | Rahman, A. | - |
dc.contributor.author | Kong, S. | - |
dc.contributor.author | Zalutskaya, A. | - |
dc.contributor.author | Louie-Gao, M. | - |
dc.contributor.author | Boral, A. L. | - |
dc.contributor.author | Mazieres, J. | - |
dc.date.accessioned | 2023-01-02T08:02:37Z | - |
dc.date.available | 2023-01-02T08:02:37Z | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.created | 2022-12-01 | - |
dc.date.issued | 2022-11 | - |
dc.identifier.citation | Annals of Oncology, Vol.33 No.11, pp.1168-1178 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://hdl.handle.net/10371/188797 | - |
dc.description.abstract | Background: RET fusions are present in 1%-2% of non-small-cell lung cancer (NSCLC). Pralsetinib, a highly potent, oral, central nervous system-penetrant, selective RET inhibitor, previously demonstrated clinical activity in patients with RET fusion -positive NSCLC in the phase I/II ARROW study, including among treatment-naive patients. We report an updated analysis from the ARROW study. Patients and methods: ARROW is a multi-cohort, open-label, phase I/II study. Eligible patients were > 18 years of age with locally advanced or metastatic solid tumours and an Eastern Cooperative Oncology Group performance status of 0-2 (later 0-1). Patients initiated pralsetinib at the recommended phase II dose of 400 mg once daily until disease progression, intolerance, consent withdrawal, or investigator's decision. The co-primary endpoints (phase II) were overall response rate (ORR) by blinded independent central review and safety. Results: Between 17 March 2017 and 6 November 2020 (data cut-off), 281 patients with RET fusion -positive NSCLC were enrolled. The ORR was 72% [54/75; 95% confidence interval (CI) 60% to 82%] for treatmentnaive patients and 59% (80/136; 95% CI 50% to 67%) for patients with prior platinum-based chemotherapy (enrolment cut-off for efficacy analysis: 22 May 2020); median duration of response was not reached for treatmentnaive patients and 22.3 months for prior platinum-based chemotherapy patients. Tumour shrinkage was observed in all treatmentnaive patients and in 97% of patients with prior platinum-based chemotherapy; median progression-free survival was 13.0 and 16.5 months, respectively. In patients with measurable intracranial metastases, the intracranial response rate was 70% (7/10; 95% CI 35% to 93%); all had received prior systemic treatment. In treatment-naive patients with RET fusion -positive NSCLC who initiated pralsetinib by the data cut-off (n = 116), the most common grade 3-4 treatment-related adverse events (TRAEs) were neutropenia (18%), hypertension (10%), increased blood creatine phosphokinase (9%), and lymphopenia (9%). Overall, 7% (20/281) discontinued due to TRAEs. Conclusions: Pralsetinib treatment produced robust efficacy and was generally well tolerated in treatment-naive patients with advanced RET fusion -positive NSCLC. Results from the confirmatory phase III AcceleRET Lung study (NCT04222972) of pralsetinib versus standard of care in the first-line setting are pending. | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Safety and efficacy of pralsetinib in RET fusion–positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial | - |
dc.title.alternative | Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.annonc.2022.08.002 | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.wosid | 000883334100008 | - |
dc.identifier.scopusid | 2-s2.0-85136839824 | - |
dc.citation.endpage | 1178 | - |
dc.citation.number | 11 | - |
dc.citation.startpage | 1168 | - |
dc.citation.volume | 33 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | MULTI-COHORT | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | ALK | - |
dc.subject.keywordPlus | ROS1 | - |
dc.subject.keywordAuthor | RET fusion | - |
dc.subject.keywordAuthor | non-small-cell lung cancer | - |
dc.subject.keywordAuthor | RET inhibition | - |
dc.subject.keywordAuthor | pralsetinib | - |
dc.subject.keywordAuthor | frontline therapy | - |
dc.subject.keywordAuthor | targeted therapy | - |
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