KEYNOTE-355
Trial question
What is the role of pembrolizumab chemotherapy in patients with metastatic triple-negative breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
847 female patients.
Inclusion criteria: patients with untreated locally recurrent inoperable or metastatic triple-negative breast cancer.
Key exclusion criteria: treatment with an investigational agent within 4 weeks; failure to recover from adverse events owing to previously administered therapy; immunodeficiency or immunosuppressive therapy within the previous week;.
Interventions
N=566 pembrolizumab chemotherapy (pembrolizumab 200 mg every 3 weeks plus nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin).
N=281 placebo chemotherapy (matching placebo plus nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin).
Primary outcome
Progression-free survival in patients with Combined Positive Score ≥ 10
9.7 months
5.6 months
9.7 months
7.3 months
4.8 months
2.4 months
0.0 months
Pembrolizumab
chemotherapy
Placebo
chemotherapy
Significant
increase ▲
Significant increase in progression-free survival in patients with CPS ≥ 10 (9.7 months vs. 5.6 months; HR 1.35, 95% CI 1.12 to 1.64).
Secondary outcomes
Significant increase in progression-free survival in patients with CPS ≥ 1 (7.6 months vs. 5.6 months; HR 1.54, 95% CI 1.16 to 2.04).
No significant difference in progression-free survival in patients with CPS < 1 (6.3 months vs. 6.2 months; HR 1.08, 95% CI 0.77 to 1.53).
Significant increase in progression-free survival in intention to treat population (7.5 months vs. 5.6 months; HR 1.33, 95% CI 1.08 to 1.64).
Safety outcomes
No significant difference in any adverse event.
Conclusion
In patients with untreated locally recurrent inoperable or metastatic triple-negative breast cancer, pembrolizumab chemotherapy was superior to placebo chemotherapy with respect to a progression-free survival in patients with CPS ≥ 10.
Reference
Javier Cortes, David W Cescon, Hope S Rugo et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828.
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