By Michael Dabaie

 

Merck & Co. Inc. said it had positive event-free survival data from the Phase 3 Keynote-522 study of Keytruda.

The Keynote-522 trial investigated Keytruda plus chemotherapy followed by Keytruda as monotherapy, compared with chemotherapy followed by a placebo in patients with high-risk early-stage triple-negative breast cancer. Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis, the company said.

Merck said Keytruda plus chemotherapy before surgery and continued as a single agent after surgery showed statistically significant event-free survival results versus chemotherapy alone.

Merck defined event-free survival as the time from randomization to the first occurrence of either disease progression that precluded surgery, a recurrence in the same place as the original cancer or spread to far organs or tissues, a second primary cancer, or death from any cause.

After a median follow-up of 39 months, the Keytruda regimen reduced the risk of EFS events by 37% versus the chemotherapy-placebo regimen. Merck said this is a statistically significant and clinically meaningful EFS result.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

July 15, 2021 14:22 ET (18:22 GMT)

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