Efﬁcacy comparison of toripalimab versus pembrolizumab in neoadjuvant treatment of breast cancer - impact of chemotherapy regimen and sequence on pathologic complete response

Sep 28, 2026

Real-world evidence compares the domestically developed PD-1 inhibitor toripalimab with pembrolizumab as neoadjuvant therapy for breast cancer, focusing on how treatment cycles, platinum-based chemotherapy, and chemoimmunotherapy sequencing affect pathologic complete response (pCR). In a retrospective cohort of 114 patients, primary endpoints included total pCR while breast pCR and residual cancer burden (RCB) served as secondary outcomes. Overall efficacy showed no significant difference between the two PD-1 inhibitors.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Introduction

Neoadjuvant chemotherapy and pCR

PD-1/PD-L1 immunotherapy and clinical rationale

Methods

Study design and patient stratification

Endpoints and statistical analysis

Results

Immunotherapy cycle completion and outcomes

Platinum regimen and pCR/RCB

Chemotherapy sequence and efficacy

Comparison between toripalimab and pembrolizumab

Conclusion

TYPE Original Research PUBLISHED 19 December 2025 DOI 10.3389/fonc.2025.1699963 OPEN ACCESS EDITED BY Mohamed Essameldin Abdelgawad, Egypt Center for Research and Regenerative Medicine, Egypt REVIEWED BY Mona S. Abdellateif, Cairo University, Egypt Hatem El-mezayen, Helwan University, Egypt *CORRESPONDENCE Zhe Wang [wangzhe9263@163.com](wangzhe9263@163.com)[ ](wangzhe9263@163.com)Rui Ling [lingrui0105@163.com](lingrui0105@163.com) †These authors have contributed equally to this work RECEIVED 03 October 2025 REVISED 14 November 2025 ACCEPTED 29 November 2025 PUBLISHED 19 December 2025 CITATION Zhang Y, Zhang B, Chen X, Zhang X, Liu C, Wang Z and Ling R (2025) Efﬁcacy comparison of toripalimab versus pembrolizumab in neoadjuvant treatment of breast cancer: impact of chemotherapy regimen and sequence on pathologic complete response. Front. Oncol. 15:1699963 . doi: 10.3389/fonc.2025.1699963 COPYRIGHT © 2025 Zhang, Zhang, Chen, Zhang, Liu, Wang and Ling. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Efﬁcacy comparison of toripalimab versus pembrolizumab in neoadjuvant treatment of breast cancer: impact of chemotherapy regimen and sequence on pathologic complete response Yunjiao Zhang1†, Bo Zhang2†, Xi Chen 1†, Xue Zhang 1, Chutuo Liu 1, Zhe Wang 1* and Rui Ling 1* 1 Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China, 2 Department of General Surgery, The First Afﬁliated Hospital of Soochow University, Suzhou, Jiangsu, China Objective: This real-world study aimed to compare the efﬁcacy and safety of the domestically developed PD-1 inhibitor toripalimab with pembrolizumab in the neoadjuvant treatment of breast cancer, and to further investigate the impact of treatment cycles, platinum-based chemotherapy, and chemotherapy sequencing on pathologic complete response (pCR) . Methods: This retrospective study included 114 breast cancer patients who received neoadjuvant therapy with either toripalimab or pembrolizumab at the First Afﬁliated Hospital of Air Force Medical University between January 2021 and January 2025 . Participants were stratiﬁed into groups based on: (1) immunotherapy cycles (completed 8 cycles vs. incomplete); (2) chemotherapy regimen (platinum vs. non-platinum); (3) chemotherapy sequence (EC-T, ECTCb, T-EC, TCb-EC, or other); and (4) PD-1 inhibitor type (toripalimab vs. pembrolizumab) . The primary endpoint was total pCR (tpCR; ypT0/is ypN0) . Secondary endpoints included breast pCR (bpCR) and residual cancer burden (RCB) . Statistical analyses incorporated Chi-square tests and Fisher’s exact tests for group comparisons. Baseline characteristics were compared across groups to assess the potential for confounding. Results: No signiﬁcant differences were observed in tpCR (56 .7% vs. 46. 8%; P=0 . 297) or RCB-0 rates (56 . 7% vs . 44. 7%; P=0 . 524) between patients completing versus not completing 8 immunotherapy cycles. The tpCR rate did not differ signiﬁcantly between platinum-based and non-platinum-based regimens (53 . 6% vs. 51.7%, P=0 . 843) . Chemotherapy sequence signiﬁcantly affected efﬁcacy: the TCb-EC group achieved the highest tpCR rate (79.2%), signiﬁcantly outperforming EC-T (56 . 4%) and other regimens (27 . 3%) . Toripalimab and pembrolizumab showed no signiﬁcant difference in tpCR rate (56 . 8% vs. 50. 0%, P=0 .777) or RCB-0 rate (56 . 8% vs. 48. 6%, P=0 . 903) . Conclusion: Toripalimab demonstrated non-inferior efﬁcacy compared topembrolizumab in the neoadjuvant treatment of breas

FAQs

What is the primary endpoint used in this study?

The primary endpoint is total pathologic complete response (tpCR), defined as ypT0/is and ypN0.

Does completing 8 immunotherapy cycles improve outcomes?

No significant differences were observed in tpCR or RCB-0 rates between patients who completed versus did not complete 8 immunotherapy cycles.

Which factor significantly affected pCR, chemotherapy regimen or sequence?

Chemotherapy sequence significantly affected pCR, with the TCb-EC regimen achieving the highest tpCR rate.

Sep 28, 2026

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