Efficacy
Cemi
The median follow‐up duration was 9.99 months (95% CI, 8.542–10.875) across all study arms (Response rates (ITT/randomized population).Abbreviations: Cemi, cemiplimab; CI, confidence interval; CR, complete response; Isa, isatuximab; ITT, intent‐to‐treat; MR, minimal response; PR, partial response; Q2W, every 2 weeks; Q4W, every 4 weeks; sCR, stringent complete response; VGPR, very good partial response.Estimated using Clopper–Pearson method.One‐sided significance level of 0.1.No responses were observed in 28 (26%) patients previously treated with daratumumab (anti‐CD38 monoclonal antibody targeting a different CD38 epitope than Isa) across the three arms. The ORR among patients not previously treated with daratumumab was 17.4% in the Isa arm, 30.0% in the Isa + CemiQ2W arm, and 32.0% in the Isa + CemiQ4W arm (Table Median PFS (95% CI) was similar between arms, at 2.89 months (1.97–3.81) for the Isa arm, 3.75 months (1.97–5.88) for the Isa + CemiQ2W arm, and 3.02 months (2.79–5.16) for the Isa + CemiQ4W arm (Figure Progression‐free survival across treatment arms (ITT/Randomized group). Cemi, cemiplimab; Isa, isatuximab; Q2W, every 2 weeks; Q4W, every 4 weeks.Across arms, median PFS was consistently higher among patients without versus with previous daratumumab exposure. For patients not previously treated with daratumumab, median PFS (95% CI) was 3.32 months (2.00–5.88) for the Isa arm, 3.75 months (2.00–6.28) for the Isa + CemiQ2W arm, and 4.07 months (2.89–14.55) for the Isa + CemiQ4W arm. For patients previously treated with daratumumab, median PFS (95% CI) was 2.14 months (0.92–3.25) for the Isa arm, 1.97 months (0.95–not reached [NR]) for the Isa + CemiQ2W arm, and 2.87 months (1.12–3.02) for the Isa + CemiQ4W arm.At the time of updated OS analysis (cutoff date: April 9, 2020; median follow‐up: Isa—16.79 months; Isa + CemiQ2W—16.16 months; Isa + CemiQ4W—15.74 months), OS was similar among arms, with largely overlapping OS curves. Median OS (95% CI) was NR for the Isa arm (8.936–NR), 18.96 (6.932–NR) months for the Isa + CemiQ2W arm, and 14.75 (9.04–NR) months for patients in the Isa + CemiQ4W arm (Figure Overall survival across treatment arms (ITT/randomized population). Cemi, cemiplimab; Isa, isatuximab; NR, not reached; Q2W, every 2 weeks; Q4W, every 4 weeks.