melanoma histology

Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma

In the November 20, 2020 edition of Journal of Clinical Oncology, Caroline Robert and colleagues report on Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma

PURPOSE

Patients with previously untreated BRAF wild-type advanced melanoma were treated with nivolumab monotherapy, and the CheckMate 066 trial, and investigators report on the 5-year outcomes.

PATIENTS AND METHODS

The trial was a multicenter, double-blind, phase III study, where 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomized to either nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks, in a one-to-one fashion. The primary end point was OS, and secondary end points included PFS, ORR, and safety.

RESULTS

Patients were followed for at least 5 years, randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine).  The 5-year overall survival rates were 39% with nivolumab and 17% with dacarbazine; progression free survival rates were 28% and 3%, respectively.  5-year overall survival was 38% in patients who were randomized to dacarbazine and also underwent subsequent therapy, including nivolumab (n = 37).  The overall response rate was 42% with nivolumab and 14% with dacarbazine; of the patients who were alive at 60 months, the ORR was 81% and 39%, respectively. Of the 42 patients who were treated with nivolumab and had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients who were 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.

The authors concluded “ 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 mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.”

Reference:

Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma

https://ascopubs.org/doi/full/10.1200/JCO.20.00995

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