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Patients with advanced, untreated melanoma who took a combination of two immunotherapies, nivolumab and ipilimumab, experienced statistically significantly longer progression-free survival than those who took either drug alone. In this 945-patient phase III randomized, double-blind study, patients taking the combination had a median progressionfree survival of 11.5 months, compared with 6.9 months for nivolumab alone, and 2.9 months for patients taking ipilimumab. Researchers discussed the new phase III trial at a plenary session at the American Society of Clinical Oncology (ASCO) meeting in late May, and results were published simultaneously in the New England Journal of Medicine (online May 31, 2015; doi:10.1056/NEJMoa1504030). The trial, known as CheckMate 067, confirms and strengthens safety and efficacy findings of a recent phase II study that compared the combination with ipilimumab alone (N. Engl. J. Med. 2015;372:2006–2017, May 21, 2015; doi:10.1056/NEJMoa1414428). Nivolumab inhibits PD-1, and ipilimumab inhibits CTLA-4, which are checkpoint molecules that dampen the body’s normal immune response to cancer. “In patients with PD-L1 expression of at least 5%, the median [progressionfree survival (PFS)] was the same in combination and nivolumab-only groups, 14 months, and 3.9 months with ipilimumab,” said Jedd Wolchok, M.D., Ph.D., chief, melanoma and immunotherapeutics service and Lloyd J. Old Chair for clinical investigation at Memorial Sloan–Kettering Cancer Center. “This means that sicker patients could take nivolumab alone with similar outcomes as with combination therapy,” he said. While about a third of patients stopped treatment because of side effects, there were no drug-related deaths in the combination group, and researchers now know when to stop treatment because of toxic effects, Wolchok said. At the plenary, researchers hailed the results as a breakthrough in melanoma treatment, and worthy of establishing a new standard of care for advanced disease. At the same time, discussant Leonard Saltz, M.D., chief, gastrointestinal oncology service and head, colorectal cancer section provided some real-world grounding in a discussion on the cost of these new immunotherapies. Commenting on the discussion, he said that “it is clear that these drugs offer substantial benefit to a significant number of patients, but they also carry price tags that are very high. This is a problem we have to confront because as a society the dissection can very strongly confer prognostic information.” Earlier studies dating back to the mid1960s lacked the statistical power needed to resolve this debate over the two alternatives. The studies generated divergent results, and so practice standards varied around the world, with proponents of watch and wait insisting that neck nodes could be removed later without compromising survival.

ASCO Reveals Additional Promising Results With Immunotherapies: