The KEYNOTE-355 results extend the benefits to the advanced breast cancer setting. The combination of pembrolizumab plus chemotherapy was granted Breakthrough Therapy designation by the FDA for the neoadjuvant treatment of patients with high-risk, early-stage triple-negative breast cancer. Numerous trials in the neoadjuvant and adjuvant settings have shown the benefits of pembrolizumab as monotherapy and in combination with chemotherapy in PD-L1–positive triple-negative breast cancer. Food and Drug Administration (FDA) for the treatment of patients with locally recurrent, unresectable, or metastatic triple-negative breast cancer whose tumors express PD-L1 ,” she stated. Based on the progression-free survival results from KEYNOTE-355, the combination of pembrolizumab and chemotherapy was granted accelerated approval by the U.S. “These findings provide further support for the addition of pembrolizumab to standard chemotherapy for first-line metastatic triple-negative breast cancer. Rugo presented additional endpoints from KEYNOTE-355 at the 2020 San Antonio Breast Cancer Symposium. “A subgroup analysis showed that pembrolizumab plus chemotherapy improved progression-free survival regardless of the chemotherapy partner.” Dr. Rugo, MD, Professor and Medical Director of Breast Oncology, University of California San Francisco. A trend toward improved progression-free survival was observed with PD-L1 enrichment,” said lead author Hope S. “Pembrolizumab plus chemotherapy achieved a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone for first-line treatment of PD-L1–positive metastatic triple-negative breast cancer. 1 Progression-free survival was significantly improved with pembrolizumab plus chemotherapy in PD-L1–positive triple-negative breast cancer (ie, combined positive score ≥ 10) regardless of the chemotherapy regimen used in the trial. 5.6, 7.6, and 5.4 months) hazard ratios were 0.85, 0.70, and 0.62.ĭisclosure: For full disclosures of the study authors, visit plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355. The progression-free survival among CPS subgroups of 1 to 9, 10 to 19, and 20 or greater was improved among patients given pembrolizumab versus placebo (5.7, 9.9, and 9.2 months vs. In the subgroup analysis, the overall survival among CPS subgroups of 1 to 9, 10 to 19, and 20 or greater was 13.9, 20.3, and 24.0 months with pembrolizumab and 15.5, 17.6, and 15.6 with placebo, respectively hazard ratios were 1.09, 0.71, and 0.72. At data cutoff, 636 individuals were evaluable. For progression-free survival, hazard ratios were 0.66, 0.75, and 0.82, respectively. The primary analysis revealed an overall survival hazard ratio of 0.73 among patients with a CPS of at least 10, 0.68 for those with a CPS score of at least 1, and 0.89 in the intent-to-treat population. Participants were randomly assigned to receive nab-paclitacel, paclitaxel, or gemcitabine and carboplatin, plus either pembrolizumab or placebo for up to 35 doses, until intolerable toxicity or progressive disease. The investigators focused on 847 patients with previously untreated, locally recurrent, inoperable or metastatic triple-negative breast cancer. Presented during the 2021 San Antonio Breast Cancer Symposium (SABCS Abstract GS1-02), their final results demonstrated that the addition of pembrolizumab yielded significant survival improvements over placebo and suggest that a combined positive score (CPS) of at least 10 is a “reasonable” cutoff to determine expected treatment benefit. The phase III KEYNOTE-355 study, which evaluated pembrolizumab plus chemotherapy versus chemotherapy alone in patients with previously untreated, locally recurrent, inoperable or metastatic triple-negative breast cancer, was conducted by Javier Cortes, MD, PhD, of the International Breast Cancer Center, Madrid, and colleagues. Carter, BS Posted: Tuesday, December 14, 2021 SABCS 2021: KEYNOTE-355 Final Results of Pembrolizumab Plus Chemotherapy in Triple-Negative Breast Cancerīy: Vanessa A.
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