Melanoma Coverage from Every Angle

ESMO 2019: 5-Year Survival Data on Nivolumab Plus Ipilimumab in Advanced Melanoma

By: Susan Reckling
Posted: Monday, October 7, 2019

The 5-year outcomes with nivolumab plus ipilimumab and nivolumab alone in patients with advanced melanoma from the CheckMate 067 trial confirm a long-term survival benefit with both nivolumab-containing arms versus ipilimumab. Moreover, the combination of immunotherapies did not appear to be associated with a loss of quality of life. These findings were presented by James M. Larkin, MD, PhD, of the Royal Marsden Hospital, London, and colleagues at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract LBA68).

“This 5-year analysis represents the longest phase III follow-up for checkpoint inhibitor combination therapy,” the investigators noted.

A total of 945 treatment-naive patients with stage III or IV melanoma were randomly assigned to one of three groups: nivolumab plus ipilimumab (n = 316), nivolumab alone (n = 315), and ipilimumab alone (n = 314). They were stratified by metastatic stage, PD-L1 status, and BRAF mutation status.

With at least 60-month follow-up, improvements in overall survival, progression-free survival, and response were seen in those who received nivolumab versus ipilimumab. Specifically, the median overall survival with the combination therapy was more than 60 months, compared with 36.9 months for nivolumab alone and 19.9 months for ipilimumab alone. The 5-year overall survival rates were 52%, 44%, and 26%, respectively. The 5-year progression-free survival rates also favored the combination therapy (36%, 29%, and 8%, respectively). Furthermore, during or after treatment with nivolumab, no sustained deterioration of health-related quality of life was reported; also, no new late toxic effects were observed.

Moving forward, the investigators plan to address why some patients benefit from immunotherapy and others do not. How best to select patients for immunotherapy, in melanoma as well as other tumor types, is a top focus of future research.

Disclosure: For full disclosures of the study authors, visit

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