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In ICI-naïve metastatic melanoma, 6-year data showed nivolumab plus ipilimumab improved overall and melanoma-specific survival versus nivolumab alone.

Nivolumab (NIVO) plus ipilimumab (IPI) combination provides longer overall survival (OS) compared with NIVO monotherapy in patients with immune checkpoint inhibitor (ICI) treatment–naïve unresectable/metastatic melanoma, according to findings published in the Journal of Clinical Oncology.

For the nonrandomized, retrospective analysis, Georgina V. Long, PhD, and colleagues pooled long-term patient-level data from six CheckMate studies in ICI treatment–naïve patients. The study included 1,375 patients receiving NIVO plus IPI (NIVO 1 mg/kg + IPI 3 mg/kg, or NIVO 3 mg/kg + IPI 1 mg/kg, once every 3 weeks for four doses) or NIVO monotherapy (3 mg/kg once every 2 weeks).

The researchers assessed OS for each treatment, as well as in select subgroups. Clinical factors associated with survival were also evaluated. Median follow-up for OS was 45.0 months for patients treated with NOVO plus IPI (n=839) and 35.8 months for patients treated with NIVO alone (n=536).

Compared with monotherapy, NIVO plus IPI was associated with longer OS (HR, 0.78; 95% CI, 0.67-0.91), with 6-year OS rates of 41% versus 52%, respectively. Similarly, in the pooled analysis of median melanoma-specific survival (MSS), combination therapy was associated with longer MSS compared with monotherapy (HR, 0.70; 95% CI, 0.60-0.83) with 6-year MSS rates of 58% and 45%, respectively. Additionally, the researchers observed consistent benefit in OS improvements in the NIVO plus IPI group regardless of BRAF mutation status or lactate dehydrogenase (LDH) expression levels.

Numerical OS benefit was also seen across PD-L1 expression levels but was more prominent with no/low PD-L1 expression. Clinical factors significant for better survival in both, or either, treatment arm were identified in multivariate and classification and regression tree analyses, which may help in clinical decision-making. Clinical factors associated with decreased survival in both analyses were LDH greater than the upper limit of normal with either treatment, age 65 and older with NIVO plus IPI, and the presence of liver metastases with NIVO monotherapy.

“These results add to the growing knowledge necessary to help inform treatment decisions regarding dual ICI combination versus monotherapy for metastatic melanoma and highlight a data gap regarding identification of patient characteristics for optimal ICI treatment,” the researchers concluded.