Cemiplimab-rwlc plus chemotherapy

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

The median OS was 21.9 months (95% CI, 15.5–not evaluable [NE]) in the cemiplimab-rwlc-plus-chemotherapy group and 13 months (95% CI, 11.9–16.1) in the placebo-plus-chemotherapy group (HR, 0.71; 95% CI, 0.53–0.93; P = .014).

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

The secondary end point of median PFS was 8.2 months (95% CI, 6.4–9.3) in the cemiplimab-rwlc-plus-chemotherapy group and 5.0 months (95% CI, 4.3–6.2) in the placebo-plus-chemotherapy group (HR, 0.56; 95% CI, 0.44–0.70; P < .0001).

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

Another secondary end point, the estimated proportion of patients alive at 12 months, was 65.7% (95% CI, 59.9%–70.9%) in the cemiplimab-rwlc-plus-chemotherapy group and 56.1% (95% CI, 47.5%–63.8%) in the placebo-plus-chemotherapy group.

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

Grade 3 or greater adverse events occurred in 43.6% (136 of 312) of patients who received cemiplimab-rwlc plus chemotherapy and 31.4% (48 of 153) of patients who received placebo plus chemotherapy.

A phase III, double-blind, placebo-controlled trial (EMPOWER-Lung 3 [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemotherapy and had no EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomly assigned (2:1) to receive cemiplimab-rwlc 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks along with four cycles of platinum-doublet chemotherapy. Patients also received pemetrexed maintenance as indicated. The primary end point was OS. The trial met preset OS efficacy criteria and was stopped early on the recommendation of the independent data monitoring committee.[94][Level of evidence A1]

The most common (≥15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.