Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001 |
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| Institution: | 1. Medical Oncology, The Angeles Clinic and Research Institute, Los Angeles, USA;2. Department of Dermatology, Gustave Roussy, Villejuif;3. Department of Medicine, University of Paris-Sud, Paris, France;4. Department of Medicine, University of California, San Francisco, San Francisco;5. Medical Oncology, Dana-Farber Cancer Institute, Boston;6. Department of Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA;7. Medical Oncology, Westmead Hospital, Westmead;8. Medical Oncology, Melanoma Institute Australia, Sydney;9. Medical Oncology, Macquarie University, Macquarie Park;10. Medical Oncology, University of Sydney, Sydney, Australia;11. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA;12. Department of Medicine, Centenary Institute, Sydney, Australia;13. Medical Oncology, Mayo Clinic Cancer Center–Florida, Jacksonville;14. Department of Medicine, Perlmutter Cancer Center, NYU Langone Health, New York;15. Division of Hematology Oncology, Abramson Cancer Center, Perelman Center for Advanced Medicine, University of Pennsylvania, Philadelphia;16. Medical Oncology, South Texas Accelerated Research Therapeutics, San Antonio;17. Department of Immunology, University of Pittsburgh Cancer Institute, Pittsburgh, USA;18. Kinghorn Cancer Centre, St. Vincent’s Hospital, Medical Oncology, Garvan Institute of Medical Research, Sydney;19. Medical Oncology, University of New South Wales, Sydney, Australia;20. Merck & Co., Inc., Kenilworth;21. Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA |
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| Abstract: | BackgroundPembrolizumab demonstrated robust antitumor activity and safety in the phase Ib KEYNOTE-001 study (NCT01295827) of advanced melanoma. Five-year outcomes in all patients and treatment-naive patients are reported herein. Patients whose disease progressed following initial response and who received a second course of pembrolizumab were also analyzed.Patients and methodsPatients aged ≥18 years with previously treated or treatment-naive advanced/metastatic melanoma received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks until disease progression, intolerable toxicity, or patient/investigator decision to withdraw. Kaplan–Meier estimates of overall survival (OS) and progression-free survival (PFS) were calculated. Objective response rate and PFS were based on immune-related response criteria by investigator assessment (data cut-off, September 1, 2017).ResultsKEYNOTE-001 enrolled 655 patients with melanoma; median follow-up was 55 months. Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients; median OS was 23.8 months (95% CI, 20.2–30.4) and 38.6 months (95% CI, 27.2–not reached), respectively. Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months (95% CI, 5.8–11.1) and 16.9 months (95% CI, 9.3–35.5), respectively. Median response duration was not reached; 73% of all responses and 82% of treatment-naive responses were ongoing at data cut-off; the longest response was ongoing at 66 months. Four patients all with prior response of complete response (CR)] whose disease progressed during observation subsequently received second-course pembrolizumab. One patient each achieved CR and partial response (after data cut-off). Treatment-related AEs (TRAEs) occurred in 86% of patients and resulted in study discontinuation in 7.8%; 17% experienced grade 3/4 TRAE.ConclusionsThis 5-year analysis of KEYNOTE-001 represents the longest follow-up for pembrolizumab to date and confirms the durable antitumor activity and tolerability of pembrolizumab in advanced melanoma.Clinical Trial RegistryClinicalTrials.gov, NCT01295827. |
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