39MO Phase III ENGOT-En9/LEAP-001 study: Lenvatinib + pembrolizumab (LEN/PEMBRO) vs chemotherapy (chemo) as first-line (1L) therapy for advanced or recurrent endometrial cancer

彭布罗利珠单抗 伦瓦提尼 医学 肿瘤科 化疗 内科学 子宫内膜癌 妇科 癌症 免疫疗法 甲状腺癌
作者
S. Pignata,C Marth,R.G. Moore,Mariusz Bidziński,Asude Ayhan,María Jesús Rubio Pérez,Mario Beiner,Marcia Hall,Christof Vulsteke,Elena Ioana Braicu,Kenzo Sonoda,Xiang Wu,S. Frentzas,André Mattar,J. McKenzie,Lan Yao,Vivek Khemka,Lucy Gilbert,V. Makker
出处
期刊:ESMO open [Elsevier BV]
卷期号:9: 103539-103539
标识
DOI:10.1016/j.esmoop.2024.103539
摘要

LEN/PEMBRO following prior systemic therapy in any setting, including neo/adjuvant, is a standard of care for advanced endometrial cancer (EC). The phase 3 ENGOT-en9/LEAP-001 trial (NCT03884101) compared 1L LEN/PEMBRO vs chemo in patients (pts) with advanced/recurrent EC. Eligible pts had stage III–IV or recurrent, measurable/non-measurable, radiographically apparent EC, with no prior chemo or PD ≥6 mo after neo/adjuvant platinum-based chemo. Pts were randomized 1:1 (stratified by proficient vs deficient mismatch repair status [pMMR/dMMR] and, in the pMMR stratum, by ECOG PS [0/1], measurable disease [yes/no], and chemo/chemoradiation [yes/no]) to lenvatinib 20 mg QD plus pembrolizumab 200 mg Q3W or paclitaxel 175 mg/m2 Q3W plus carboplatin AUC 6 Q3W. Dual primary endpoints were PFS (RECIST v1.1, blinded independent central review) and OS in the pMMR population and among all-comers. Secondary endpoints included ORR and safety; duration of response (DOR) was an exploratory endpoint; and efficacy outcomes assessed by tumor histology was a prespecified exploratory analysis. 842 pts were randomized. At final analysis (data cutoff, 2 Oct 2023), after median follow-up of 38.4 (range, 30.3–52.9) mo, statistical significance for noninferiority (NI) OS endpoint was not achieved for LEN/PEMBRO vs chemo in the pMMR population (HR, 1.02 [95% CI, 0.83–1.26]; NI P = 0.2459875; Table). PFS and OS results for LEN/PEMBRO vs chemo by histological subtype will be presented for the pMMR population and all-comers. Treatment-related AEs occurred in 411/420 (97.9%) vs 398/411 (96.8%) treated pts in the LEN/PEMBRO vs chemo groups.Table: 39MOpMMRAll-comersLEN/PEMBRO n = 320Chemo n = 322LEN/PEMBRO n = 420Chemo n = 422OS HR (95% CI)1.02 (0.83–1.26)a0.93 (0.77–1.12)PFS HR (95% CI)0.99 (0.82–1.21)0.91 (0.76–1.09)ORR (95% CI), %50.6 (45.0–56.2)54.7 (49.0–60.2)55.7 (50.8–60.5)55.5 (50.6–60.3)Median DOR (range), mo16.1 (1.0+ to 48.7+)10.6 (1.1+ to 43.8+)23.2 (1.0+ to 49.0+)10.9 (1.1+ to 46.9+)a1-sided NI P = 0.2459875 (nonsignificant), not crossing prespecified OS NI boundary, P = 0.0158890, so no further statistical testing of efficacy endpoints was performed per prespecified multiplicity strategy for type 1 error control. Open table in a new tab a1-sided NI P = 0.2459875 (nonsignificant), not crossing prespecified OS NI boundary, P = 0.0158890, so no further statistical testing of efficacy endpoints was performed per prespecified multiplicity strategy for type 1 error control. The prespecified statistical criteria for OS and PFS in pts with pMMR IL advanced/recurrent EC were not met. Subgroup analyses identifying pts who may benefit most from LEN/PEMBRO will be presented. The safety profile was manageable and consistent with prior experience.
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