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At a maximum tolerated dose of pembrolizumab 200 mg every 3 wk for 4 cycles added to standard therapy in patients with HR+, HER2−, and triple-negative breast cancer, the Bayesian probability of superior pathologic control rates was 99.0%.
Why this matters
Pembrolizumab is an anti-PD-1 antibody with single-agent activity in HER2− metastatic breast cancer.
ISPY-2 studies its activity in patients with HER2−, HR+/HER2−, and HR−/HER2− cancers.
Tumors can coopt the PD-1 pathway to evade immune surveillance.
Multicenter phase 2 platform trial (n=2048).
Two groups: paclitaxel 80 mg/m2/wk×12 wk (n=180) vs paclitaxel+pembrolizumab 200 mg every 3 wk, 4 cycles (n=69), followed by doxorubicin and cyclophosphamide, standard dose.
Sponsor: QuantumLeap Healthcare Collaborative.
Bayesian model generates predictive probability distributions of estim...