KEYNOTE-522
Trial question
What is the role of pembrolizumab and chemotherapy in patients with early-stage triple-negative breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
1174 female patients.
Inclusion criteria: patients with previously untreated stage II or III triple-negative breast cancer.
Key exclusion criteria: history of invasive malignancy in the past 5 years; prior chemotherapy, targeted therapy, or radiotherapy within the past 12 months; receipt of a live vaccine within 30 days of the first dose of study treatment; active autoimmune diseases that have required systemic treatment in the past 2 years; immunodeficiency or receipt of systemic corticosteroid therapy.
Interventions
N=784 pembrolizumab (neoadjuvant therapy with 4 cycles of pembrolizumab 200 mg every 3 weeks plus chemotherapy).
N=390 placebo (matching placebo plus chemotherapy).
Primary outcome
Overall survival at 5 years
86.6%
81.7%
86.6 %
64.9 %
43.3 %
21.6 %
0.0 %
Pembrolizumab
Placebo
Significant
increase ▲
NNT = 20
Significant increase in overall survival at 5 years (86.6% vs. 81.7%; AD 4.9%, 95% CI 0.3 to 9.4).
Secondary outcomes
Significant increase in event-free survival (79.7% vs. 70.8%; HR 1.54, 95% CI 1.2 to 1.96).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with previously untreated stage II or III triple-negative breast cancer, pembrolizumab was superior to placebo with respect to overall survival at 5 years.
Reference
Peter Schmid, Javier Cortes, Rebecca Dent et al. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):1981-1991.
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