Photo Credit: Mohammed Haneefa Nizamudeen
The following is a summary of “First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial,” published in the November 2024 issue of Oncology by Marth et al.
Lenvatinib plus pembrolizumab (len+ pembro) showed improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy in advanced or recurrent endometrial cancer (aEC) in the phase III study 309/KEYNOTE-775.
Researchers conducted a prospective study evaluating len+pembro versus chemotherapy in the first-line treatment of advanced or recurrent aEC in the phase III European Network of Gynecological Trial-en9/LEAP-001 study.
They randomly assigned patients with stage III to IV or recurrent, radiographically apparent endometrial cancer who had not received previous chemotherapy or had disease progression at least 6 months after platinum-based chemotherapy to either lenatinib 20 mg daily plus pembrolizumab every 3 weeks or paclitaxel (175 mg/m2) plus carboplatin (AUC 6 mg/mL/min) every 3 weeks. The primary endpoints were PFS and OS in both the mismatch repair-proficient (pMMR) and all-comers populations. Noninferiority for OS was assessed at the final analysis (FA).
The results showed that a total of 842 patients were randomly assigned (len + pembro, n=420 [pMMR population, n=320]; chemotherapy, n=422 [pMMR population, n=322]). At the final analysis (data cutoff, October 2, 2023), median PFS was 9.6 (8.2 to 11.9) vs. 10.2 (8.4 to 10.5) months in the pMMR population (HR, 0.99 [95% CI: 0.82 to 1.21]) and 12.5 (10.3 to 15.1) vs. 10.2 (8.4 to 10.4) months in all-comers (HR, 0.91 [95% CI, 0.76 to 1.09]). Median OS in pMMR was 30.9 (25.4 to 37.7) vs. 29.4 (26.2 to 35.4) months (HR, 1.02 [95% CI: 0.83 to 1.26]) and in all-comers was 37.7 (32.2 to 43.6) vs. 32.1 (27.2 to 35.7) months (HR, 0.93 [95% CI, 0.77 to 1.12]). Grade ≥3 treatment-related adverse events occurred in 79% (331/420) vs. 67% (274/411) of patients.
Investigators concluded that first-line len + pembro did not meet the prespecified statistical criteria for PFS or OS compared to chemotherapy in patients with mismatch repair-proficient aEC.
Source: ascopubs.org/doi/10.1200/JCO-24-01326
