Updated results from the RELATIVITY-047 trial in patients with advanced melanoma show that differences in overall survival and objective response rate seen with a relatlimab/nivolumab combination over nivolumab monotherapy did not reach statistical significance.
New data presented at the ASCO March Plenary Series by Professor Georgina Long of the Melanoma Institute Australia, based on a median follow-up of 19.3 months of 714 patients, showed that the median OS was not yet reached with LAG-3 and PD-1 immune checkpoint inhibitors but was 34.1 months with nivolumab (HR 0.80; 95% CI [0.6, 1.0]; P = .0593).
The OS difference with relatlimab-nivolumab compared to nivolumab was 77% vs. 71.6% at 12 months, 63.7% vs. 58.3% at 24 months and 55.8% vs. 48.8% at 36 months.
The objective response rate at median follow up was 43.1% for patients who received relatlimab and nivolumab, as compared with 32.6% of patients who received nivolumab. Complete response rates with the combination versus monotherapy were 16.3% and 14.2%, respectively.
More grade 3 and 4 treatment-related adverse events were observed in the relatlimab and nivolumab group (21.1%) compared to the nivolumab group (11.1%).
According to the study investigators the adverse events were deemed manageable and those associated with relatlimab and nivolumab were similar to those seen with other immune-oncology agents and no new information on any new or known adverse events were observed.
While it was disappointing that the interim results did not match the statistically significant benefits previously reported in PFS with relatlimab-nivolumab, the study authors said the differences in OS were ‘clinically meaningful’