Keytruda extends survival in high-risk triple negative breast cancer
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A study assessing the efficacy of pembrolizumab met a key secondary endpoint of extending OS, in combination with chemotherapy, among patients with high-risk early-stage triple-negative breast cancer, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, has two approved indications for triple-negative breast cancer.
The double-blind phase 3 KEYNOTE 522 trial assessed the efficacy and safety of chemotherapy plus either pembrolizumab or placebo among patients with high-risk early-stage triple-negative breast cancer.
“This is a significant milestone, as it is the first time an immunotherapy-based regimen has demonstrated a statistically significant overall survival benefit compared [with] chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer,” Gursel Aktan, MD, PhD, vice president of global clinical development at Merck, said in a press release. “To have achieved overall survival from this landmark study is highly encouraging and builds upon the positive pathological complete response and event-free survival results that led to approvals for this regimen around the world.”
The study comprises two patient cohorts, including those who received either pembrolizumab or placebo plus chemotherapy, followed by one of the two plus chemotherapy as neoadjuvant therapy prior to surgery, followed by pembrolizumab or chemotherapy monotherapy as adjuvant therapy following surgery.
Researchers randomly assigned 784 patients in a 2:1 ratio to either the investigative agent cohort and 390 patients to placebo.
Pathological complete response and EFS served as the study’ s dual primary endpoints, with OS serving as a key secondary endpoint.
According to topline data from the manufacturer, pembrolizumab demonstrated a “statistically significant and clinically meaningful improvement” in OS at a pre-specified interim analysis when compared with preoperative chemotherapy.
The safety of pembrolizumab in the KEYNOTE 522 trial remained consistent with previously reported studies, with no new safety signals observed.
Data will be shared at an upcoming medical conference.
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