Merck Reports Positive Phase 3 KEYTRUDA Plus Chemotherapy Trial Results In TNBC Patients

(RTTNews) - Merck & Co., Inc. (MRK) announced Tuesday positive result from its Phase 3 KEYNOTE-522 trial evaluating anti-PD-1 therapy KEYTRUDA in combination with chemotherapy in patients with high-risk early-stage triple-negative breast cancer or TNBC.

The KEYTRUDA trial met its overall survival or OS endpoint, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant) to treat TNBC.

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.

The company noted that the safety profile of KEYTRUDA was consistent with that observed in previously reported studies.

Merck will present the results at an upcoming medical meeting and will share with regulatory authorities.

KEYNOTE 522 is the fourth study of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit. The other ones are KEYNOTE-A18 in cervical cancer, KEYNOTE-671 in non-small cell lung cancer and KEYNOTE-564 in renal cell carcinoma.

Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, "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. 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."

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