Expert: Anti-PD-1 monoclonal antibody blocking immune checkpoint

Everyday: Helps immune system recognize and attack cancer

Targets: ["PD-1"]

Primary EP: [{"id":"lung1-os","name":"Overall Survival (OS)","type":"CO_PRIMARY","unit":"months","results":[{"notes":"Median OS 26.1 months","value":26.1,"arm_id":"cemiplimab-lung1","arm_name":"Cemiplimab"},{"val

Efficacy: OS 26.1 vs 13.3 months (HR 0.57, p=0.0002). PFS 8.2 vs 5.7 months (HR 0.54, p<0.0001). Strong monotherapy activity in PD-L1 ≥50% NSCLC.

Safety: EMPOWER-Lung 1 (n=710): Typical PD-1 profile. Pneumonitis 5%, hypothyroidism 12%.

Primary EP: [{"id":"cscc1-orr","name":"Objective Response Rate (ORR)","type":"PRIMARY","unit":"%","results":[{"notes":"47% ORR (95% CI 40-54%). CR 17%, PR 30%.","value":47,"arm_id":"cemiplimab-mcscc","arm_name":"

Efficacy: EMPOWER-CSCC-1: 47% ORR (95% CI 40-54%) with 17% CR. Median DOR 41 months — durable responses. First systemic therapy showing activity in advanced CSCC.

Safety: EMPOWER-CSCC-1 (n=193, open-label): Fatigue 38%, rash 34%, MSK pain 33%, diarrhea 26%. SAEs 41%. Discontinuation due to AEs 12%. Typical PD-1 inhibitor safety profile.

REGN took back full global rights from Sanofi (2022). +19% YoY. First PD-1 approved for advanced CSCC (first-in-class for this cancer). Also approved in BCC and 1L NSCLC (PD-L1≥50%). Key pipeline role: backbone for fianlimab (LAG-3) combination in melanoma and other tumors.

{"keyRisks":[{"category":"Immune-mediated adverse reactions","description":"Pneumonitis, colitis, hepatitis, nephritis, endocrinopathies, skin reactions. Standard PD-1 class risk. Require corticosteroid management.","incidenceRate":"1-10% each"},{"category":"Infusion-related reactions","description":"Occurred in 2% of patients. Grade 3-4 in <1%.","incidenceRate":"2%"}],"monitoring":["LFTs before each dose","Thyroid function Q6W","Signs of pneumonitis, colitis, hepatitis"],"classWarnings":["PD-1 inhibitor class: immune-mediated adverse reactions can affect any organ system","Requires monitoring of liver, thyroid, renal, and adrenal function"],"hasBoxedWarning":false}