Nivolumab + Ipilimumab Tops Ipilimumab Alone in Metastatic Melanoma

WEDNESDAY, Aug. 23, 2023 (HealthDay News) -- For patients with metastatic melanoma who receive frontline anti-programmed death protein 1 (PD-1) or therapy against programmed cell death 1 ligand 1 and whose tumors progressed with cytotoxic T-lymphocyte protein 4 (CTLA-4) blockade alone, continued blockade of PD-1 and CTLA-4 resulted in improved progression-free survival over CTLA-4 blockade alone, according to a study published online Aug. 17 in Nature Medicine.

Ari VanderWalde, M.D., from The West Clinic-Wolf River in Germantown, Tennessee, and colleagues conducted a randomized phase 2 trial to compare blockade of CTLA-4 to continuation of PD-1 blockade in patients with metastatic melanoma who had received frontline anti-PD-1 or therapy against programmed cell death 1 ligand 1 and whose tumors progressed with CTLA-4 blockade alone. Ninety-two patients were randomly assigned to the combination of ipilimumab and nivolumab or ipilimumab alone (3:1 ratio).

The researchers found that compared with ipilimumab alone, the combination of nivolumab and ipilimumab resulted in a significant improvement in progression-free survival (hazard ratio, 0.63). Objective response rates were 28 and 9 percent, respectively, for the combination of nivolumab and ipilimumab and ipilimumab alone. In 57 and 35 percent of patients, grade 3 or higher treatment-related adverse events occurred, consistent with known toxicity profiles.

"On the basis of these results, the combination of nivolumab and ipilimumab should be considered the preferred regimen over ipilimumab alone to treat patients with advanced melanoma not responding to previous anti-PD-1, although patients and physicians should consider the corresponding increase in toxicity," the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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