Adjuvant nivolumab provides benefit

Patients with melanoma who have successfully undergone resection but who are at high risk for relapse have substantially better outcomes with adjuvant nivolumab than the current standard-of-care ipilimumab [1].

The new results, presented by Prof. Jeffrey S. Weber (NYU Langone Medical Center, New York City, USA), come from the phase 3 CheckMate 238 trial, which was stopped early owing to benefit. The primary endpoint was recurrence-free survival (RFS) in the intention-to-treat population, with overall survival, safety, side-effect profiles, and RFS relative to tumour PD-L1 expression. Adjuvant nivolumab increased RFS by a significant 35% compared with adjuvant ipilimumab while also reducing the rate of grade ≥3 adverse effects by approximately a third (see Figure).

Figure. Sustained long-term improvement in recurrence-free survival with nivolumab vs ipilimumab as adjuvant treatment for resected stage IIIB/IIIC or IV melanoma.



© Jeffrey S. Weber (provided by ESMO).

CheckMate 238 was a randomised, double-blind, phase 3 trial that included 906 patients who had undergone complete resection for stage IIIB, IIIC, or IV melanoma, who were randomly allocated to receive either nivolumab 3 mg/kg (n=453) every 3 weeks for 4 doses or ipilimumab 10 mg/kg every 3 weeks for 4 doses and then once every 12 weeks (n=453). At 3 years of follow-up, nivolumab continued to demonstrate superior RFS compared with ipilimumab, the active control, with RFS rates of 58% and 45%, respectively (HR 0.68; 95% CI 0.56–0.82; P<0.0001). Distant-metastasis-free survival also continued to be significantly longer for nivolumab, with 36-month rates of 66% and 58%, respectively (HR 0.78; 95% CI 0.62–0.99; P=0.044). Both RFS and distant-metastasis-free survival benefit continued to be observed across key subgroups, including disease stages, BRAF mutation status and PD-L1 expression. No new safety data were generated as part of the 36-month analysis.

1. Weber J et al. ESMO Congress 2019. Abstract 1310O.

Posted on 26 November 201918 March 2021