Benmelstobart Plus Chemotherapy and Anlotinib Improves Outcomes in Advanced Endometrial Cancer
According to results from a phase 2 trial, benmelstobart plus chemotherapy and anlotinib, followed by maintenance benmelstobart and anlotinib, improved outcomes among previously untreated patients with advanced or recurrent endometrial cancer.
These data were first presented by Xiaojun Chen, MD, Shanghai Tenth People's Hospital, Shanghai, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this open-label study, 71 patients with primary stage III or IV recurrent endometrial cancer who had not received systemic anticancer therapy in the first-line setting were randomized on a 1-to-1 basis to receive 1200 mg of benmelstobart plus carboplatin (AUC 5 mg/mL) and paclitaxel (175 mg/m2) once every 3 weeks for 6 to 8 cycles with (n = 38) or without (n = 33) 8 mg of daily anlotinib (for 2 weeks on and 1 week off) followed by maintenance benmelstobart with or without maintenance anlotinib. Patients were stratified based on mismatch repair status. The primary end point was objective response rate (ORR). Key secondary end points included progression-free survival (PFS), overall survival (OS), and safety.
At analysis, ORR was 86.1% in the benmelstobart plus anlotinib arm and 80.6% in the benmelstobart arm. Median PFS was not reached in the benmelstobart plus anlotinib arm and 8.41 months in the benmelstobart arm. PFS benefit was also observed in patients with proficient mismatch repair (pMMR) tumors. Median OS was not reached in either treatment arm. Grade ≥ 3 treatment-emergent adverse events occurred in 81.58% of patients in the benmelstobart plus anlotinib arm and 75.76% of patients in the benmelstobart arm. The most frequent grade ≥ 3 treatment-emergent adverse events occurring in ≥ 20% of patients included decreased white blood cell count, thrombocytopenia, and anemia.
“The regimen was particularly helpful in improving outcomes for patients with pMMR tumors, potentially providing a new treatment option,” concluded Dr Chen et al.
Source:
Chen X, Zhang K, Wang K, et al. Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract 5508
