Background
Phase 3, open-label, randomized (2:1), 14 Chinese hospitals. N=369 enrolled (mITT n=352) women with previously untreated stage II-III TNBC. Camrelizumab is an anti-PD-1 antibody; regimen tests anthracycline-free neoadjuvant chemoimmunotherapy.
Results
Interventions and follow up: Arm A: camrelizumab 200 mg IV D3 + docetaxel 75 mg/m2 + carboplatin AUC 6 D1, x6 cycles (n=233)
Arm B: docetaxel + carboplatin alone, same schedule (n=119)
Primary endpoint: pCR (ypT0/Tis ypN0) in mITT
mFollow up: NR
Results: pCR: 57.5% (134/233) vs 45.4% (54/119), difference 12.2% (95% CI 1.4–22.9), one-sided P=.014
EFS / OS: NR
Arm B: docetaxel + carboplatin alone, same schedule (n=119)
Primary endpoint: pCR (ypT0/Tis ypN0) in mITT
mFollow up: NR
Results: pCR: 57.5% (134/233) vs 45.4% (54/119), difference 12.2% (95% CI 1.4–22.9), one-sided P=.014
EFS / OS: NR
Adverse events
Grade 3–4 TRAEs: 24.9% (58/233) vs 21.8% (26/119)
Treatment-related deaths: none
Immune-mediated AEs: NR
Treatment-related deaths: none
Immune-mediated AEs: NR
Conclusions
Adding camrelizumab to docetaxel-carboplatin significantly increased pCR in stage II-III TNBC with manageable safety, supporting an anthracycline-free chemoimmunotherapy approach worth comparing with current standard.
Key Limitations
Primary endpoint is pCR with no EFS/OS data; open-label; no head-to-head against KEYNOTE-522 regimen; control arm lacks immunotherapy so does not reflect current standard; one-sided P-value; China-only population; efficacy population excluded patients without study treatment.
Clinical Context
Current standard is KEYNOTE-522 (pembrolizumab + carboplatin/paclitaxel then AC/EC), which improved EFS and OS. This trial supports a de-escalated, anthracycline-free option but needs EFS data and a comparison against the standard; no approval claimed.
