Long-term data from CheckMate 067

Prof. James Larkin (Royal Marsden NHS Foundation Trust, London, UK) presented the 5-year analysis of CheckMate 067, which represents the longest phase 3 follow-up for checkpoint inhibitor combination therapy and demonstrated long-term survival with both nivolumab-containing arms vs ipilimumab. In descriptive analyses, nivolumab plus ipilimumab was associated with improved survival and a higher likelihood of being alive and treatment-free compared with nivolumab alone, both without loss of quality-of-life.

The 5-year analysis is the longest phase 3 follow-up for checkpoint inhibitor combination therapy. A total of 945 patients with previously untreated stage III or IV melanoma were randomly allocated in a 1:1:1 ratio to 1) nivolumab plus ipilimumab; 2) nivolumab plus placebo; or 3) ipilimumab plus placebo until progression or unacceptable toxicity. Each nivolumab arm was compared with ipilimumab monotherapy.

The 5-year overall survival rates were 52% for nivolumab plus ipilimumab, 44% for nivolumab, and 26% for ipilimumab (see Table). The median time from randomisation to subsequent therapy was 8 months with ipilimumab monotherapy, 25.2 months with nivolumab monotherapy, and as yet unreached with combination immunotherapy. The proportion of patients alive and free from subsequent therapy at 5 years was 45% with ipilimumab, 58% with nivolumab, and 74% with combination therapy. Quality of life was preserved in both nivolumab arms. Prof. Larkin said there is currently no method to predict which patients are most likely to benefit from combination immunotherapy.

Table. Summary of key results from CheckMate-067.



© James Larkin (provided by ESMO).

1. Larkin J et al. ESMO Congress 2019. Abstract LBA68_PR.

Posted on 26 November 201918 March 2021