Single-center phase 2 trial of neoadjuvant anthracycline followed by toripalimab plus nab-paclitaxel for stage II or III triple-negative breast cancer

The preferred treatment approach for stage II or III triple-negative breast cancer (TNBC) is neoadjuvant chemotherapy followed by surgery. The phase 2 NeoTENNIS trial at Fudan University (Shanghai, China) evaluated toripalimab (anti-PD-1) integrated in the neoadjuvant regimen for early-stage TNBC. Patients received neoadjuvant epirubicine-cyclophosphamide followed by toripalimab plus nab-paclitaxel followed by surgery. The percentage of patients with total pathological complete response was 55.7% (95% CI 43.3-67.6) and the percentage of patients with breast pathological complete response was 58.6% (95% CI 46.2-70.2). Grade ≥ 3 adverse events were seen in 22.9%. The most common immune-related adverse event was hypothyroidism (7.1%; all grade 1 or 2). The authors conclude that toripalimab included in a neoadjuvant chemotherapy regimen conferred encouraging activity with manageable toxicity in patients with early TNBC.