This phase 3, randomized, open-label trial compared the efficacy and safety of benmelstobart (TQB2450), a programmed death-ligand 1–targeting monoclonal antibody, combined with anlotinib, an anti-angiogenic tyrosine kinase inhibitor, versus nab-paclitaxel as first-line treatment for recurrent or metastatic triple-negative breast cancer (TNBC). A total of 147 patients were randomized, with 75 receiving benmelstobart plus anlotinib and 72 receiving nab-paclitaxel. The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR) per RECIST V1.1, and secondary endpoints included investigator-assessed PFS, objective response rate, duration of response, time to response, clinical benefit rate, overall survival (OS), and safety.
Baseline characteristics were well balanced between the 2 arms. Median PFS was 7.85 months for benmelstobart plus anlotinib versus 5.55 months for nab-paclitaxel (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.46-1.06; P=.1687). Median OS was 35.81 months for benmelstobart plus anlotinib compared with 21.03 months for nab-paclitaxel (HR, 0.78; 95% CI, 0.49-1.24; P=.2625).
Grade ≥3 drug-related adverse events (AEs) occurred in 58.7% of patients in the study group versus 36.6% in the control group. The most common grade ≥3 AEs in the benmelstobart plus anlotinib group were hypertension (28.0%) and hypertriglyceridemia (13.3%).
The combination of benmelstobart and anlotinib demonstrated a numerical improvement in PFS and OS compared with nab-paclitaxel in patients with recurrent or metastatic TNBC, though statistical significance was not achieved. The safety profile aligned with known toxicities of the agents, and further research is required to validate the clinical benefit of this combination therapy.
Source: Wang J, et al. ETER901: a randomized, open-label, phase III trial of anlotinib in combination with anti-PD-L1 antibody benmelstobart (TQB2450) versus nab-paclitaxel in first-line treatment of recurrent or metastatic triple-negative breast cancer. Presented at: 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract 1104.