Results of the
Dr. Merrick I. Ross
IMMUNED was a multicenter German double-blind, placebo-controlled, phase 2 trial conducted by the Dermatologic Cooperative Oncology Group. It included 167 patients with resected stage IV melanoma and no evidence of disease who were randomized to adjuvant nivolumab (Opdivo) plus placebo, nivolumab plus ipilimumab (Yervoy), or double placebo, with relapse-free survival as the primary outcome, Merrick I. Ross, MD, explained at a forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.
“The patients who received adjuvant ipilimumab and nivolumab had amazing 24-month outcomes: a relapse-free survival of 70% versus 42% with nivolumab and 14% with placebo,” observed Dr. Ross, professor of surgical oncology and chief of the melanoma section at the University of Texas M.D. Anderson Cancer Center, Houston.
“It’s not a long-term survival outcome, but we’ll see what happens long term. This could be a very interesting approach to move forward with,” he commented.
By way of background, the cancer surgeon noted that nivolumab has achieved standard-of-care status as adjuvant immunotherapy in patients with resected stage IIIB-C and stage IV melanoma, largely on the strength of the CheckMate-238 trial, which randomized 906 such patients at 130 academic centers in 25 countries to 1 year of adjuvant therapy with either intravenous nivolumab or ipilimumab. In the study, nivolumab emerged as the clear winner, with a 4-year recurrence-free survival of 51.7%, compared with 41.2% for ipilimumab, for a 29% relative risk reduction. Ipilimumab was associated with greater toxicity.
The between-group difference in relapse-free survival in the overall study population also held true in the subgroup comprised of 169 CheckMate 238 participants with resected stage IV melanoma and no evidence of disease at enrollment, Dr. Ross noted.
In the IMMUNED trial, the superior outcome achieved with adjuvant nivolumab plus ipilimumab came at the cost of significantly greater toxicity than with nivolumab alone. Treatment-related adverse events led to medication discontinuation in 62% of the dual-adjuvant therapy group, compared with 13% of those on adjuvant nivolumab.
IMMUNED was funded by Bristol-Myers Squibb.
Dr. Ross reported having no financial conflicts regarding his presentation.
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