Nivolumab

A multicenter, placebo-controlled, double-blind, randomized, phase III trial (CONFIRM [NCT03063450]) included 332 patients with malignant pleural or peritoneal mesothelioma and disease progression after previous first-line platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either nivolumab, an anti–programmed death 1 (PD-1) antibody, at a flat dose of 240 mg intravenously every 2 weeks (n = 221), or placebo (n = 111) until disease progression or a maximum of 12 months. Co-primary end points were investigator-assessed PFS and OS.[12]

A multicenter, placebo-controlled, double-blind, randomized, phase III trial (CONFIRM [NCT03063450]) included 332 patients with malignant pleural or peritoneal mesothelioma and disease progression after previous first-line platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either nivolumab, an anti–programmed death 1 (PD-1) antibody, at a flat dose of 240 mg intravenously every 2 weeks (n = 221), or placebo (n = 111) until disease progression or a maximum of 12 months. Co-primary end points were investigator-assessed PFS and OS.[12]

The median OS was 10.2 months (95% CI, 8.5–12.1) in the nivolumab group and 6.9 months (95% CI, 5.0–8.0) in the placebo group (HR, 0.69; 95% CI, 0.52–0.91; P = .0090). Programmed death-ligand 1 (PD-L1) expression was not predictive of response to treatment for either OS or PFS based on a positivity threshold of 1%.

A multicenter, placebo-controlled, double-blind, randomized, phase III trial (CONFIRM [NCT03063450]) included 332 patients with malignant pleural or peritoneal mesothelioma and disease progression after previous first-line platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either nivolumab, an anti–programmed death 1 (PD-1) antibody, at a flat dose of 240 mg intravenously every 2 weeks (n = 221), or placebo (n = 111) until disease progression or a maximum of 12 months. Co-primary end points were investigator-assessed PFS and OS.[12]

At a median follow-up of 11.6 months, the median PFS was 3.0 months (95% CI, 2.8–4.1) in the nivolumab group and 1.8 months (95% CI, 1.4–2.6) in the placebo group (HR, 0.67; 95% CI, 0.55–0.85; P = .0012).[12][Level of evidence A1]

A multicenter, placebo-controlled, double-blind, randomized, phase III trial (CONFIRM [NCT03063450]) included 332 patients with malignant pleural or peritoneal mesothelioma and disease progression after previous first-line platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either nivolumab, an anti–programmed death 1 (PD-1) antibody, at a flat dose of 240 mg intravenously every 2 weeks (n = 221), or placebo (n = 111) until disease progression or a maximum of 12 months. Co-primary end points were investigator-assessed PFS and OS.[12]

The overall response rate was 11% in the nivolumab group and 1% in the placebo group (odds ratio, 14.0; 95% CI, 2.4–not estimable; P = .00086).

A multicenter, placebo-controlled, double-blind, randomized, phase III trial (CONFIRM [NCT03063450]) included 332 patients with malignant pleural or peritoneal mesothelioma and disease progression after previous first-line platinum-based chemotherapy. Patients were randomly assigned (2:1) to receive either nivolumab, an anti–programmed death 1 (PD-1) antibody, at a flat dose of 240 mg intravenously every 2 weeks (n = 221), or placebo (n = 111) until disease progression or a maximum of 12 months. Co-primary end points were investigator-assessed PFS and OS.[12]

Serious adverse events occurred in 41% of patients in the nivolumab group and 44% of patients in the placebo group. There were no treatment-related deaths in either group.