Patients
PD
MULTIPLE MYELOMA, DISEASE, DEL(17P), T(4;14), ONCOLOGY, DISEASE CHARACTERISTIC, T(14;16)
A total of three patients were enrolled in Phase 1 at a dose of Isa + CemiQ2W. Two patients were male, all were between 63 and 68 years of age, and all had an ECOG PS of 0 or 1. Two patients discontinued study treatment due to progressive disease (PD); the other patient withdrew from the study after the first cycle (patient withdrawal). For Phase 2, 106 patients were randomized: 34 patients to isatuximab alone, 36 to Isa + CemiQ2W, and 36 to Isa + CemiQ4W. Overall, patient demographics and baseline disease characteristics were similar between all arms, with some differences observed mostly in the Isa + CemiQ2W arm with more prevalent high‐risk cytogenetics and International Staging System (ISS) stage III (Table Summary of patient demographics and other baseline characteristics (ITT/randomized population).Abbreviations: Cemi, cemiplimab; ECOG PS, Eastern Cooperative Oncology Group performance status; Ig, immunoglobulin; IMiD, immunomodulatory drug; Isa, isatuximab; ISS, International Staging System; ITT, intent‐to‐treat; MM, multiple myeloma; PI, proteasome inhibitor; Q2W, every 2 weeks; Q4W, every 4 weeks.High‐risk defined as presence of del(17p) (10% cutoff), and/or t(4;14) (15% cutoff), and/or t(14;16) (15% cutoff).Patients (Patients were heavily pretreated. The median number of prior lines of therapy was 4 in each arm (up to 9 and 11), 37.7% of patients received ≥5 previous lines of therapy, and 84.0% were refractory to the last regimen. The vast majority was treated with alkylating agents, PIs, and IMiDs. The majority was double refractory to PIs and IMiDs. Overall, 28 patients (26.4%) had received previous daratumumab treatment, four of whom received daratumumab as the last line of therapy. The median time from last dose of daratumumab to first dose of isatuximab was 9 (range, 2.1–22.1) months; some patients received the first dose of isatuximab after a shorter washout period than recommended.At the data cutoff date (October 9, 2019), 14 patients remained on treatment, including five patients each in the Isa and Isa + CemiQ2W arm and four patients in the Isa + CemiQ4W arm. Across all arms, the most common reason for definitive treatment discontinuation was PD (Isa, 82.4%; Isa + CemiQ2W, 72.2%; Isa + CemiQ4W, 66.7%) (Table 