Merck: Phase 3 Keytruda Trial Meets 2nd Key Endpoint in Triple-Negative Breast Cancer
By Colin Kellaher
Merck & Co. on Thursday said a pivotal Phase 3 study of its
blockbuster cancer drug Keytruda met a second primary endpoint of
event-free survival in patients with high-risk early-stage
triple-negative breast cancer.
The Kenilworth, N.J., drugmaker said Keytruda in combination
with chemotherapy before surgery and continuing as a single agent
after surgery showed statistically significant improvement in
event-free survival versus pre-operative chemotherapy.
Merck, which previously reported that the study had met its
other dual primary endpoint of pathological complete response, said
Keytruda is the first anti-PD-1 therapy to show a statistically
significant improvement in event-free survival as a neoadjuvant and
adjuvant therapy for patients with triple-negative breast cancer,
an aggressive cancer that characteristically has a high recurrence
rate within the first five years after diagnosis.
The U.S. Food and Drug Administration in March turned away
Merck's application for expanded approval of Keytruda for patients
with high-risk early-stage triple-negative breast cancer based on
the pCR data and early interim event-free survival findings. The
agency was following advice from an advisory committee that
recommended a regulatory decision on the indication should be
deferred until further data were available from the study.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
May 13, 2021 07:27 ET (11:27 GMT)
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