EU Approves Merck's Keytruda Combination For Early-stage Triple-negative Breast Cancer

The European Commission has approved Keytruda, Merck's anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer or TNBC at high risk of recurrence, Merck & Co Inc. (MRK) said in a statement on Tuesday.

The approval was based on results from the pivotal Phase 3 KEYNOTE-522 trial, in which Keytruda in combination with chemotherapy before surgery and continued as a single agent after surgery prolonged event-free survival (EFS), reducing the risk of EFS events or death by 37% compared to neoadjuvant chemotherapy alone in this patient population. Median follow-up time for all patients was 37.8 months.

The safety of Keytruda plus chemotherapy has been evaluated in 3,123 patients across tumor types. The incidence of Grade 3-5 adverse reactions in patients with TNBC was 80% for KEYTRUDA plus chemotherapy and 77% for chemotherapy.

The approval allows marketing of the Keytruda regimen in all 27 EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland. This is the second indication for Keytruda in breast cancer in Europe.

In October 2021, Keytruda plus chemotherapy was approved for the first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Activity in the U.S. manufacturing sector slowed by more than expected in the month of September but still saw continued growth, according to a report released by the Institute for Supply Management on Monday. Stocks have moved sharply higher in morning trading on Monday, regaining ground following a dismal September. The major averages have all shown substantial moves to the upside. Swedish geneticist Svante Paabo has won this year's Nobel Prize in Physiology/Medicine for his discoveries concerning the genomes of extinct hominins and human evolution. Through his pioneering research, Svante Pääbo accomplished something seemingly impossible: sequencing the genome of the Neanderthal, an extinct relative of present-day humans. He also made the sensational discovery of a previous
Follow RTT