KENILWORTH (NJ) (dpa-AFX) - 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.'

For More Such Health News, visit rttnews.com



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX