CheckMate 7FL
Trial question
What is the role of nivolumab in addition to neoadjuvant chemotherapy in patients with ER+/HER- breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
510 patients (509 female, 1 male).
Inclusion criteria: patients with high-risk, early-stage ER+/HER- breast cancer.
Key exclusion criteria: prior treatment with chemotherapy, endocrine therapy, targeted therapy, and/or radiotherapy for currently diagnosed breast cancer significant CVD; pregnancy or lactation.
Interventions
N=257 nivolumab plus neoadjuvant chemotherapy (nivolumab either 360 mg every 3 weeks or 240 mg every 2 weeks in combination with anthracycline and cyclophosphamide).
N=252 placebo plus neoadjuvant chemotherapy (matching placebo in combination with anthracycline and cyclophosphamide).
Primary outcome
Pathological complete response
24.5%
13.8%
24.5 %
18.4 %
12.3 %
6.1 %
0.0 %
Nivolumab plus neoadjuvant
chemotherapy
Placebo plus neoadjuvant
chemotherapy
Significant
increase ▲
NNT = 9
Significant increase in pathological complete response (24.5% vs. 13.8%; OR 2.05, 95% CI 1.29 to 3.27).
Secondary outcomes
Significant increase in residual cancer burden 0 or 1 (30.7% vs. 21.3%; OR 1.65, 95% CI 1.1 to 2.49).
Significant increase in pathological complete response rate in patients with anti-PD-L1 status ≥ 1% (44.3% vs. 20.2%; AD 24.1%, 95% CI 10.1 to 36.7).
Significant increase in residual cancer burden 0 or 1 in patients with anti-PD-L1 status ≥ 1% (55.7% vs. 26.2%; AD 29.5%, 95% CI 14.9 to 42.4).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with high-risk, early-stage ER+/HER- breast cancer, nivolumab plus neoadjuvant chemotherapy was superior to placebo plus neoadjuvant chemotherapy with respect to pathological complete response.
Reference
Sherene Loi, Roberto Salgado, Giuseppe Curigliano et al. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):433-441.
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