Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma

Caroline Robert, Georgina V. Long, Benjamin Brady, Caroline Dutriaux, Anna Maria Di Giacomo, Laurent Mortier, Piotr Rutkowski, Jessica C. Hassel, Catriona M. McNeil, Ewa Anna Kalinka, Céleste Lebbé, Julie Charles, Micaela M. Hernberg, Kerry J. Savage, Vanna Chiarion-Sileni, Catalin Mihalcioiu, Cornelia Mauch, Ana Arance, Francesco Cognetti, Lars NyHenrik Schmidt, Dirk Schadendorf, Helen Gogas, Jesús Zoco, Sandra Re, Paolo A. Ascierto, Victoria Atkinson

Research output: Contribution to journalArticlepeer-review


PURPOSE The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated BRAF wild-type advanced melanoma. Five-year results are presented herein. PATIENTS AND METHODS In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. RESULTS Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n 5 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report. CONCLUSION Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.
Original languageEnglish
Pages (from-to)3937-3946
Number of pages10
JournalJournal of Clinical Oncology
Issue number33
Publication statusPublished - Nov 20 2020


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