Tuesday, Merck & Co Inc (NYSE:MRK) released topline data from hase 3 KEYNOTE-522 trial of Keytruda in high-risk early-stage triple-negative breast cancer (TNBC).
The study evaluated Keytruda in combination with chemotherapy as a pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant).
The study met its overall survival (OS) endpoint.
At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, Keytruda demonstrated a statistically significant and clinically meaningful improvement in OS compared to pre-operative chemotherapy.
Related: Merck Halts Skin Cancer Drug Trial On High Discontinuation Rate – A Setback in High-Risk Melanoma Treatment.
“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, Merck Research Laboratories.
KEYNOTE 522 is the fourth study of a Keytruda-based regimen in an earlier stage of cancer to demonstrate an OS benefit, in addition to KEYNOTE-A18 in cervical cancer, KEYNOTE-671 in non-small cell lung cancer, and KEYNOTE-564 in renal cell carcinoma.
Earlier this month, Merck’s Phase 3 KEYNOTE-B21 trial of Keytruda in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival in newly diagnosed, high-risk endometrial cancer after surgery with curative intent.
Price Action: MRK shares are down 2.21% at $126.63 at the last check on Tuesday.
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