TOPLINE:

The final, 10-year results of the international randomised clinical trial known as CheckMate 067 report that the median overall survival with advanced melanoma is nearly 72 months with the combination of nivolumab + ipilimumab, nearly 37 months with nivolumab monotherapy, and only 20 months with ipilimumab monotherapy. Both agents are immune checkpoint inhibitors, but their immune targets differ.

METHODOLOGY:

• A double-blinded, phase 3, randomised clinical trial (CheckMate 067) comparing nivolumab + ipilimumab (n = 314) vs monotherapy with either nivolumab (n = 316) or ipilimumab (n = 315) and comparing one monotherapy to the other.
• The primary outcomes were overall survival and progression-free survival.

TAKEAWAY:

• At 10 years, the median overall survival for nivolumab + ipilimumab, nivolumab, and ipilimumab was 71.9, 36.9, and 19.9 months, respectively.
• At 10 years, the median progression-free survival for nivolumab + ipilimumab, nivolumab, and ipilimumab was 11.5, 6.9, and 2.9 months, respectively.
• At 10 years, the median melanoma-specific survival for nivolumab + ipilimumab, nivolumab, and ipilimumab was not reached, 49.4 months, and 21.9 months, respectively.
• The overall survival for patients who had been alive and progression-free at 3 years for nivolumab + ipilimumab (n = 100), nivolumab (n = 78), and ipilimumab (n = 21) was not reached in all groups.

IN PRACTICE:

The authors concluded that “as compared with ipilimumab monotherapy, nivolumab-containing therapies have continued to show a prolonged survival benefit in patients with advanced melanoma, with no new safety signals. These 10-year data underscore how immune checkpoint inhibitor therapy has helped to change the long-term prognosis for patients with advanced melanoma and highlight the potential for a cure in patients who have response to this type of treatment.”

SOURCE:

The lead and corresponding author is Jedd D Wolchok of the Sandra and Edward Meyer Cancer Center, Weill Cornell Medicine, New York. The study appeared online in The New England Journal of Medicine.

LIMITATIONS:

Approximately 40% of patients did not respond to treatment.

DISCLOSURES:

Multiple authors declared competing interests. The study received funding from Bristol Myers Squibb, among others.