Merck & Co (MRK) announced on Tuesday that its phase 3 KEYNOTE-522 trial evaluating Keytuda successfully met its overall survival endpoint in patients with high-risk early-stage triple-negative breast cancer.
Keytruda is Merck’s immunotherapy medicine developed to treat different types of cancer.
Shares in MRK rose more than 1% in premarket trading Tuesday, though these gains were later reduced to 0.6%.
According to the results of the trial, the safety profile of Keytruda was consistent with previous studies, and no new safety signals were observed.
“This is a significant milestone, as it is the first time an immunotherapy-based regimen has demonstrated a statistically significant overall survival benefit compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer,” said Dr. Gursel Aktan, vice president, global clinical development at Merck Research Laboratories.
“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.”
KEYNOTE-522 is the fourth KEYTRUDA-based regimen study to show overall survival benefits, following KEYNOTE-A18 in cervical cancer, KEYNOTE-671 in non-small cell lung cancer, and KEYNOTE-564 in renal cell carcinoma.