In the longest follow-up results from a clinical trial of combination immunotherapy for metastatic melanoma, investigators report that nearly half the patients who received the drugs nivolumab and ipilimumab were alive at a median of 6.5 years after treatment. These long-term results from the CheckMate 067 clinical trial, presented at the 2021 ASCO Annual Meeting by Jedd D. Wolchok, MD, PhD, FASCO, represent a new landmark in survival rates for patients with melanoma treated with immune checkpoint inhibitors (Abstract 9506).
Jedd D. Wolchok, MD, PhD, FASCO
CheckMate 067 Details
The clinical trial compared nivolumab and ipilimumab, alone and in combination, in patients with previously untreated stage III or IV melanoma that could not be removed surgically. Both drugs target proteins on T cells known as immune checkpoints, which some cancer cells exploit to spare themselves from an attack by the T cells. By interfering with these proteins, the drugs essentially release the brakes on such an attack. Nivolumab targets the PD-1 checkpoint protein, and ipilimumab targets the CTLA-4 checkpoint protein.
In the trial, patients were randomly assigned to receive nivolumab and ipilimumab in combination, nivolumab plus a placebo, or ipilimumab alone. Six and a half years after treatment, participants who received the nivolumab/ipilimumab combination were more likely to be alive and to have had no advance of their disease than those who received either drug alone. At the 6.5-year mark, 49% of participants treated with the combination therapy were alive, compared to 42% of those treated with nivolumab alone and 23% of those treated with ipilimumab alone. Progression-free survival was 34% for the combination therapy group, 29% for the nivolumab-only group, and 7% for the ipilimumab-only group.
Median survival followed the same pattern. For patients treated with nivolumab and ipilimumab, median survival was 72.1 months, or just over 6 years. For those treated with just nivolumab, median survival was 36.9 months, and for those treated with just ipilimumab, it was 19.9 months.
The study authors concluded, “This 6.5-year analysis represents the longest follow-up from a phase III melanoma trial in the modern checkpoint inhibitor combination therapy and targeted therapy era. The results show durable improved outcomes with nivolumab/ipilimumab and nivolumab vs ipilimumab in patients with advanced melanoma. We observed improvement in overall survival, progression-free survival, and objective response rate with nivolumab/ipilimumab over nivolumab alone.”
Disclosure: The clinical trial was supported by Bristol Myers Squibb. For full disclosures of the study authors, visit coi.asco.org.
