Neoadjuvant Anthracycline Followed by Toripalimab Combined with Nab-paclitaxel in Patients with Early Triple-negative Breast Cancer (NeoTENNIS): a Single-arm, Phase II Study

Overview

Journal EClinicalMedicine

Specialty General Medicine

Date 2024 Jul 24

PMID 39045544

Authors

Min He

Shuang Hao

LinXiaoxi Ma

Bingqiu Xiu

Benlong Yang

Zehao Wang

Jingyan Xue

Yayun Chi

Min Xiong

Jiajian Chen

Xiaoyan Huang

Xiyu Liu

Songyang Wu

Qin Xiao

Yan Huang

Ruohong Shui

AYong Cao

Junjie Li

Genhong Di

Wentao Yang

Xin Hu

Guangyu Liu

Keda Yu

Yizhou Jiang

Zhonghua Wang

Zhiming Shao

Jiong Wu

Affiliations

Soon will be listed here.

Abstract

Background: Toripalimab, a novel PD-1 antibody, is approved for treatment of multiple solid tumors; however, its neoadjuvant use with chemotherapy for triple-negative breast cancer (TNBC) remains unevaluated. Additionally, induction chemotherapy followed by de-escalation of neoadjuvant immunotherapy remains underexplored. Therefore, we conducted a phase II trial investigating a novel neoadjuvant chemoimmunotherapy regimen including de-escalation of immunotherapy for early-stage TNBC.

Methods: Chemotherapy and anti-PD-1 therapy were sequentially administered in a neoadjuvant setting to female patients with histologically confirmed stage II-III TNBC between June 9, 2020, and March 24, 2022. Patients received neoadjuvant therapy with four cycles of epirubicin-cyclophosphamide every 2 weeks, followed by toripalimab (240 mg) every 3 weeks plus nab-paclitaxel weekly for 12 weeks. The primary endpoint was total pathological complete response (tpCR; ypT0/is ypN0). Key secondary endpoints included breast pCR (bpCR; ypT0/is), event-free survival and biomarker analysis. Safety was also assessed. This study was registered with ClinicalTrials.gov (NCT04418154).

Findings: Among 70 enrolled patients (median age, 51 years; 62.9% stage III), 66 completed treatment without progression and subsequently underwent surgery. The percentages of patients with a tpCR and bpCR were 39 of 70 (55.7%, 95% confidence interval [CI]: 43.3-67.6) and 41 of 70 (58.6%, 95% CI 46.2-70.2), respectively. Sixteen (22.9%) patients experienced grade ≥3 adverse events (AEs), frequently neutropenia (12, 17.1%) and leukopenia (11, 15.7%). The most common immune-related AE was hypothyroidism (5, 7.1%, all grade 1-2).

Interpretation: Including 12 weeks of toripalimab in neoadjuvant chemotherapy conferred encouraging activity and manageable toxicity in patients with early TNBC, and this regimen warrants further investigation.

Funding: National Natural Science Foundation of China, Junshi Biosciences, and Jiangsu Hengrui Pharmaceuticals.

Citing Articles

Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Guidelines in 2024: International Contributions from China.

Li J, Jiang Z Cancer Biol Med. 2024; 21(10).

PMID: 39434380 PMC: 11523271. DOI: 10.20892/j.issn.2095-3941.2024.0374.

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