Cemiplimab-rwlc alone

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

At 35 months of follow-up, in patients with PD-L1 expression ≥50%, the median OS was 26.1 months with cemiplimab-rwlc and 13.3 months with chemotherapy (HR, 0.57; P < .0001).

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

The median PFS was 8.1 months for patients who received cemiplimab-rwlc and 5.3 months for patients who received chemotherapy (HR, 0.51; P < .0001).

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

The objective response rate was 46% for patients who received cemiplimab-rwlc and 21% for patients who received chemotherapy (OR, 3.264; P < .0001).

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

Benefits were greater in patients with PD-L1 expression ≥90% versus 50% to 89%.

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

Among 64 patients who received cemiplimab-rwlc plus chemotherapy after initial progression while receiving cemiplimab-rwlc alone, the median PFS was 6.6 months, the objective response rate was 31%, and the OS was 15.1 months.

A phase III open-label study (EMPOWER-Lung 1 [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1) to receive cemiplimab-rwlc 350mg every 3 weeks for up to 108 weeks or platinum-doublet chemotherapy. Patients could cross over from chemotherapy to cemiplimab-rwlc in the event of disease progression. There was also the option to cross over to continue cemiplimab-rwlc plus four cycles of chemotherapy in the event of progression with cemiplimab alone. Primary end points were OS and PFS per blinded independent central review. The median follow-up was 37 months for the ITT population.[95,96][Level of evidence A1]

The most common adverse reactions (>10%) with cemiplimab-rwlc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough. The safety profile of cemiplimab-rwlc was consistent over longer follow-up.