Objectives EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 is an open-label, randomized (1:1), multi-center, Phase 3 trial of cemiplimab vs investigator’s choice (IC) chemotherapy (chemo) in recurrent/metastatic (R/M) cervical cancer that has progressed after first-line (1L) platinum-based treatment (tx).
Methods Patients (pts) were enrolled regardless of PD-L1 expression; received cemiplimab 350 mg IV Q3W or IC chemo (pemetrexed, vinorelbine, gemcitabine, irinotecan, or topotecan), up to 96 weeks; and were stratified by histology (squamous cell carcinoma [SCC]/adenocarcinoma or adenosquamous [AC]). Primary endpoint was OS, analyzed hierarchically in pts with SCC followed by total population (SCC + AC). Additional endpoints included PFS, ORR, QoL, and safety. Interim analysis was scheduled when 85% events occurred among SCC pts.
Results 608 pts were randomized: median age, 51 years (range, 22–87); 477 SCC, 131 AC; ECOG performance status: 0 (46.5%), 1 (53.5%). Median cemiplimab exposure was 15 weeks (range, 1.4–100.7). At interim analysis, OS (table 1), PFS, ORR in overall and SCC populations, and mean change from baseline QoL in SCC, favored cemiplimab. Most common tx emergent AEs of any grade for cemiplimab vs IC chemo were anemia (25% vs 45%), nausea (18% vs 33%), and vomiting (16% vs 23%). Discontinuation due to AEs occurred in 8% (cemiplimab) and 5% (IC chemo).
Conclusions Cemiplimab significantly improves OS over single agent chemo for pts with R/M cervical cancer after 1L platinum-based tx regardless of histology and despite not having been selected by PD-L1 status. No new safety signals were observed.
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