Benefits of immunotherapy combination persist for more than six years in advanced melanoma

A higher percentage of patients treated with nivolumab and ipilimumab in clinical studies achieved the six and a half year survival rate than those treated with either drug alone.

BOSTON – In the longest follow-up results of a clinical trial of combination immunotherapy for metastatic melanoma, researchers report that nearly half of the patients who received the drugs nivolumab and ipilimumab were alive an average of six and a half years after treatment. The results, from the CheckMate 067 clinical trial, represent a new milestone in survival rates for patients with melanoma treated with immune checkpoint inhibitors.

F. Stephen Hodi, MD, the director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute is a co-senior author on the study. The findings will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2021, which will be held nearly June 4-8.

The clinical study compared nivolumab and ipilimumab, alone and in combination, in patients with previously untreated stage III or IV melanoma that could not be removed by surgery. Both drugs target proteins on T cells known as immune checkpoints, which some cancer cells use to protect themselves from an attack by the T cells. By disrupting these proteins, the drugs essentially release the brakes on such an attack. Nivolumab targets the PD-1 checkpoint protein, ipilimumab targets the CTLA-4 checkpoint protein.

In the study, patients were randomly assigned to receive nivolumab and ipilimumab in combination, nivolumab plus 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 no progression of their disease than those who received either drug alone.

At six and a half years, 49% of the participants treated with the combination therapy were alive, compared with 42% of those treated with nivolumab alone and 23% of those treated with ipilimumab alone. Progression-free survival – the percentage of patients who were alive and whose cancer had not progressed – was 34% for the combination therapy group, 29% for the nivolumab-only group, and 7% for the ipilimumab-only group.

The median survival – the length of time that at least half of the patients were alive – followed the same pattern. For patients treated with nivolumab and ipilimumab, the median survival was 72.1 months or slightly over 6 years. For those treated with nivolumab alone, the median survival was 36.9 months and for those treated with ipilimumab alone it was 19.9 months.

“This is the longest follow-up of a phase III clinical trial of advanced melanoma, including nivolumab plus ipilimumab,” said Hodi. “It confirms a lasting sustainable benefit for the combination.”


The clinical trial was supported by Bristol Myers Squibb.

CheckMate 067: 6.5-year results in patients (pts) with advanced melanoma (abstract 9506) will be virtually presented at the Melanoma / Skin Cancer Oral Abstract Session on Sunday, June 6, 2021, 8 am-11am.

For all ASCO related media inquiries, please call or email Victoria Warren, 617-939-5531, Follow the meeting live on Twitter with the hashtag # ASCO21 and follow Dana-Farber on Twitter at @DanaFarberNews.

About the Dana-Farber Cancer Institute

The Dana-Farber Cancer Institute is one of the world’s leading centers for cancer research and care. Dana-Farber’s mission is to reduce the burden of cancer through scientific research, clinical care, education, community involvement and advocacy. The institute offers the latest cancer treatments for adults through Dana-Farber / Brigham and Women’s Cancer Center and for children through Dana-Farber / Boston Children’s Cancer and Blood Disorders Center.

Dana-Farber is the only hospital in the entire country with a US News & World Report Top 6 Best Cancer Hospital in both adult and pediatric care.

As a world leader in oncology, Dana-Farber is committed to a unique and equal balance between cancer research and care, translating the results of discoveries into new treatments for patients locally and around the world, with more than 1,100 therapeutic and clinical trials.

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