Can toripalimab be used as neoadjuvant and adjuvant therapy for breast cancer?

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Last updated: September 15, 2026 • View editorial policy

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Toripalimab in Breast Cancer: Current Evidence and Recommendations

Toripalimab is NOT currently recommended as standard neoadjuvant or adjuvant therapy for breast cancer based on available guidelines and FDA labeling. The FDA-labeled indications for toripalimab (provided in the evidence) are actually for topiramate (an antiepileptic drug), not the PD-1 inhibitor toripalimab, indicating no FDA approval for breast cancer at this time 1.

Current Standard of Care for Immune Checkpoint Inhibitors in Breast Cancer

Triple-Negative Breast Cancer (TNBC)

For stage II-III TNBC, pembrolizumab (not toripalimab) combined with neoadjuvant chemotherapy is the established standard. The 2025 St. Gallen consensus specifically recommends neoadjuvant chemoimmunotherapy for patients with stage 2 or 3 TNBC, with neoadjuvant therapy preferred for tumors ≥2 cm 2. The 2024 ESMO guidelines similarly recommend pembrolizumab plus chemotherapy for cT2-4 N0 or any N-positive TNBC 3.

Key treatment algorithm:

  • cT1c-4 N0 or any N-positive TNBC: Neoadjuvant treatment is preferred 3
  • Stage II-III TNBC: Pembrolizumab every 3 weeks throughout neoadjuvant phase, then nine 3-week cycles adjuvantly regardless of pathologic complete response (pCR) status 3
  • Adjuvant-only checkpoint inhibitors: NOT recommended without prior neoadjuvant administration 2, 3

HR-Positive/HER2-Negative Breast Cancer

Immune checkpoint inhibitors are NOT standard therapy for HR+/HER2- breast cancer. The 2025 St. Gallen guidelines make no recommendation for immunotherapy in this subtype 2. While exploratory research is investigating toripalimab combined with chemotherapy and radiotherapy in HR+/HER2- disease, this remains investigational only 4.

HER2-Positive Breast Cancer

Immune checkpoint inhibitors are NOT part of standard treatment for HER2-positive breast cancer. Guidelines focus on anti-HER2 therapies (trastuzumab, pertuzumab, trastuzumab deruxtecan) without immunotherapy 2, 3.

Toripalimab-Specific Evidence

The only clinical evidence for toripalimab in breast cancer comes from:

  1. Phase II exploratory study in HR+/HER2- disease combining toripalimab with chemotherapy and radiotherapy - this is hypothesis-generating only, not practice-changing 4

  2. Single case report of TACE plus toripalimab/nab-paclitaxel in giant ulcerated TNBC achieving pCR - interesting but insufficient for clinical recommendations 5

Critical Caveats

Pembrolizumab is the only FDA-approved checkpoint inhibitor for early breast cancer (specifically TNBC). Extrapolating from pembrolizumab data to toripalimab is inappropriate without dedicated phase III trials demonstrating equivalent efficacy and safety 6.

Immune-related adverse events require close monitoring, including permanent endocrinopathies 2, 3. Combining multiple agents (e.g., toripalimab plus olaparib, or with CDK4/6 inhibitors) outside of clinical trials is problematic as toxicity profiles remain uncharacterized 6.

For TNBC patients requiring immunotherapy: Use pembrolizumab per established protocols. Toripalimab should only be considered within clinical trial settings until phase III data demonstrate non-inferiority or superiority to pembrolizumab.

References

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