KEY TAKEAWAYS
- The LEAP-001 phase 3 trial aimed to compare lenvatinib plus pembro to chemo in advanced/recurrent endometrial cancer patients, excluding prior chemo or neo/adjuvant progression.
- The dual primary endpoints are PFS and OS. Recruitment is ongoing, data will be presented upon completion.
In the randomized phase 3 Study 309/KEYNOTE-775 trial, lenvatinib plus pembrolizumab (pembro) showed superior progression-free survival (PFS) and overall survival (OS) in patients with advanced endometrial cancer.
Christian Marth and the team conducted a study that aimed to assess lenvatinib plus pembro versus chemotherapy (chemo) in advanced or recurrent endometrial cancer patients.
About 842 patients across 22 countries were enrolled. Eligible patients have advanced (stage III-IV) or recurrent endometrial cancer with radiographically visible disease, either untreated with chemo (hormonal therapy and chemoradiation allowed) or progressed ≥6 months after neo/adjuvant chemo. Patients were randomized 1:1 to receive pembro 200 mg every 3 weeks plus lenvatinib 20 mg daily or paclitaxel 175 mg/m2 every 3 weeks plus carboplatin AUC 6 every 3 weeks.
Stratification for randomization was based on proficient versus deficient mismatch repair (pMMR vs dMMR) status. Within the pMMR population (N=642), further stratification occurs based on prior adjuvant chemo/chemoradiation, measurable disease, and ECOG performance status. Treatment continued for up to 35 cycles of pembro, 7 cycles of chemo, or until disease progression, initiation of a new anticancer treatment, unacceptable toxicity, or withdrawal of consent.
The primary endpoints are PFS and OS in the pMMR and intention-to-treat groups, assessed per RECIST version 1.1 by blinded independent central review. Secondary endpoints include objective response rate (ORR), health-related quality-of-life (HRQoL), and safety and tolerability. Duration of response is an exploratory endpoint. PFS and OS between treatment arms will be compared using a stratified log-rank test. The study is ongoing, results will be presented upon completion.
The trial is sponsored by Merck Sharp & Dohme LLC.
Source: https://sgo.planion.com/Web.User/AbstractDet?ACCOUNT=SGO&ABSID=586489&CONF=AM2024&CKEY=
Clinical Trial: https://clinicaltrials.gov/study/NCT03884101
Marth C, Moore RG, Bidzinski M, et al. (2024) “Lenvatinib plus pembrolizumab versus chemotherapy as first-line therapy for advanced or recurrent endometrial cancer: Primary results of the phase III ENGOT-En9/LEAP-001 study.” Presented at SGO 2024.
