Dr Wang on Updated Efficacy and Safety Data With First-Line Ivonescimab Plus Chemotherapy in TNBC

"[Based on these updated] study results, we find that this regimen is very efficacy and [has a] good safety [profile] for this patient [population]."

Xiaojia Wang, MD, an oncologist in the Department of Breast Medical Oncology at the Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital; as well as a key researcher at the Institute of Cancer and Basic Medicine (IBMC) at the Chinese Academy of Sciences in Hangzhou, China, discusses findings from an ongoing phase 2 trial (NCT05227664) evaluating ivonescimab (SMT112) in combination with paclitaxel or nab-paclitaxel (Abraxane) in patients with locally advanced unresectable or metastatic triple-negative breast cancer (TNBC).

Updated findings from this study demonstrated the efficacy and safety of ivonescimab in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic TNBC, Wang said. As of the data cutoff on September 30, 2024, 35 patients evaluable for efficacy achieved an objective response rate (ORR) of 80.0% (95% CI, 63.1%-91.1%) and a disease control rate (DCR) of 100.0% (95% CI, 90.0%-100.0%). The median duration of response (DOR) was 7.49 months (95% CI, 5.32-not evaluable [NE]).

When patients were stratified by PD-L1 combined positive score (CPS), the ORR was 83.3% (95% CI, 35.9%-99.6%) in the subgroup with a CPS of 10 or greater and 79.3% (95% CI, 60.3%-92.0%) in the subgroup with a CPS of less than 10. The median progression-free survival (PFS) across the full cohort was 9.36 months (95% CI, 6.24-NE), with a 9-month PFS rate of 61.3% (95% CI, 39.7%-77.1%); this outcome included patients with a CPS less than 10 and less than 1, he added.

Treatment-related adverse effects (TRAEs) were reported in all patients (100%), with 50.0% of patients (n = 18) experiencing grade 3 or higher TRAEs. No TRAEs led to treatment discontinuation or death. The most common TRAEs were decreased white blood cell and neutrophil counts.

Overall, this updated analysis, which included additional patients enrolled after the prior data cutoff, demonstrated an improved ORR in the overall population, Wang emphasized. These results support further investigation of ivonescimab plus chemotherapy as a potential first-line treatment option for patients with advanced TNBC, he concluded.