Nivolumab With Relatlimab Continues to Show Benefit in Patients With Advanced Melanoma

For immediate release
March 14, 2022


Rachel Facci

ASCO Expert Perspective
“The updated data from RELATIVITY-047 further support the use of nivolumab plus relatlimab over single agent anti-PD-1 therapy for patients who have previously untreated advanced melanoma. Combination therapy demonstrated higher overall response rate and continued to show superior progression-free survival compared to nivolumab in exchange for only a modest increase in side effects. If approved, I expect that nivolumab plus relatlimab will become a standard first-line regimen for the treatment of unresectable or metastatic melanoma.”
Allison Betof Warner, MD, PhD, ASCO Expert in Melanoma

In patients with previously untreated metastatic or unresectable melanoma, the combination of nivolumab and relatlimab (NIVO + RELA) continued to demonstrate a progression-free survival (PFS) benefit compared to nivolumab (NIVO) alone. The combination also demonstrated for the first time a higher overall response rate (ORR) according to follow-up data from the RELATIVITY-047 trial. These data will be presented during an ASCO Plenary Series session taking place March 15, 2022, at 5:00 p.m. ET.

In this phase II/III trial, 714 patients were randomized 1:1 to receive NIVO + RELA (355 patients) or NIVO (359 patients). After a median follow up of 19.3 months, updated median PFS was 10.2 months with NIVO + RELA compared to 4.6 months with NIVO.

The OS benefit with RELA + NIVO vs. NIVO was not statistically significant however was clinically meaningful:

  • 77% vs. 71.6% at 12 months
  • 63.7% vs. 58.3% at 24 months
  • 55.8% vs. 48.8% at 36 months

Median OS was not yet reached with NIVO + RELA compared to 34.1 months with NIVO.

More grade 3 and 4 treatment-related adverse events were observed in the RELA + NIVO group (21.1%) compared to the NIVO group (11.1%). There were four (1.1%) treatment-related deaths in the NIVO + RELA group and two (0.6%) in the NIVO group. Treatment-related adverse events leading to treatment discontinuation were observed in 15.2% of patients treated with RELA + NIVO and 7.2% of patients treated with NIVO. According to the authors, the types of adverse events associated with RELA + NIVO are similar to those seen with other immune-oncology agents and no new information on any new or known adverse events were observed.

“These findings provide additional evidence of the benefit of two checkpoint inhibitors over only one and supports the combination of nivolumab and relatlimab, which had a manageable safety profile, as a potential new treatment option for patients with advanced melanoma,” said Georgina V. Long, MD, FRACP, PhD, chair of melanoma medical oncology and translational research at the Melanoma Institute Australia at the University of Sydney.

This research was funded by Bristol Myers Squibb.

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