Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Cancer Med. 2024 Sep;13(18):e70236. doi: 10.1002/cam4.70236.
In the phase 3 EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 study, cemiplimab significantly improved overall survival (OS) versus chemotherapy for patients with recurrent or metastatic cervical cancer who progressed after first-line platinum-based chemotherapy. We present a post hoc subgroup analysis of patients enrolled in Japan.
Patients were enrolled regardless of programmed cell death-ligand 1 status and randomized 1:1 to cemiplimab 350 mg intravenously every 3 weeks or investigator's choice single-agent chemotherapy for up to 96 weeks. Primary endpoint was OS. Key secondary endpoints were progression-free survival (PFS) and objective response rate (ORR).
Overall, 608 patients were randomized, of whom 56 (9.2%) were in Japan (cemiplimab, n = 29; chemotherapy, n = 27). The median (range) duration of follow-up was 13.6 (6.0-25.3) versus 18.2 (6.0-38.2) months for patients in Japan and for the overall population, respectively. Median OS (95% confidence interval [CI]) was 8.4 (7.0-not evaluable) and 9.4 (5.4-14.9) months for cemiplimab versus chemotherapy (hazard ratio [HR]: 0.86; 95% CI: 0.43-1.68). Median PFS (95% CI) was 4.0 (1.4-8.2) versus 3.7 (1.8-4.2) months with cemiplimab and chemotherapy (HR: 0.90; 95% CI: 0.50-1.61), respectively. ORR was 17.2% for cemiplimab and 7.4% for chemotherapy (odds ratio, 2.47; 95% CI, 0.44-13.99). Incidence of treatment-emergent adverse events at any grade was 79.3% for cemiplimab and 100% for chemotherapy. Grade ≥3 adverse events were 37.9% versus 66.7% with cemiplimab and chemotherapy, respectively.
While acknowledging limitations inherent to a small subgroup analysis, the HR of 0.86 observed in Japanese patients suggests an emerging survival benefit despite a 4.6-month shorter median duration of follow-up versus the overall study population.
在 3 期 EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 研究中，与化疗相比，西普立单抗显著改善了复发或转移性宫颈癌患者的总生存期（OS），这些患者在一线含铂化疗后进展。我们报告了在日本入组患者的事后亚组分析结果。
患者入组时无论程序性死亡配体 1 状态如何，均按 1:1 随机分组，接受西普立单抗 350mg 静脉输注，每 3 周 1 次或研究者选择的单药化疗，最长 96 周。主要终点为 OS。关键次要终点为无进展生存期（PFS）和客观缓解率（ORR）。
总体而言，608 例患者被随机分组，其中 56 例（9.2%）来自日本（西普立单抗组 n=29；化疗组 n=27）。日本患者和总体人群的中位（范围）随访时间分别为 13.6（6.0-25.3）个月和 18.2（6.0-38.2）个月。西普立单抗组和化疗组的中位 OS（95%CI）分别为 8.4（7.0-无法评估）和 9.4（5.4-14.9）个月（风险比[HR]：0.86；95%CI：0.43-1.68）。西普立单抗组和化疗组的中位 PFS（95%CI）分别为 4.0（1.4-8.2）和 3.7（1.8-4.2）个月（HR：0.90；95%CI：0.50-1.61）。西普立单抗组和化疗组的 ORR 分别为 17.2%和 7.4%（优势比，2.47；95%CI，0.44-13.99）。西普立单抗组任何级别治疗相关不良事件发生率为 79.3%，化疗组为 100%。西普立单抗组和化疗组的≥3 级不良事件发生率分别为 37.9%和 66.7%。
虽然承认这是一项小型亚组分析固有的局限性，但与总体研究人群相比，日本患者的 HR 为 0.86，提示尽管中位随访时间缩短了 4.6 个月，但仍存在生存获益的趋势。
