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EMA's CHMP Recommends Keytruda Neoadjuvant, Adjuvant Therapy in Triple-Negative Breast Cancer

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Monday recommended Merck's Keytruda (pembrolizumab) as a neoadjuvant and adjuvant therapy for patients with triple-negative breast cancer.

Based on results from Merck's Phase III KEYNOTE-522 trial, CHMP recommended Keytruda with chemotherapy as a neoadjuvant treatment, then as a single-agent adjuvant treatment after surgery for locally advanced or early-stage TNBC patients at high risk of recurrence. In the trial, Keytruda treatment resulted in a 37 percent reduction in events or death at a median follow-up of 39 months. The pathologic complete response rate was 63 percent compared to 56 percent for patients receiving chemotherapy alone.

The US Food and Drug Administration approved Keytruda in this indication in July 2021. Keytruda is also approved in the US and EU for advanced TNBC patients whose tumors express PD-L1.

TNBC is a subset of breast tumors, which lack estrogen or progesterone receptors as well as HER2 overexpression, making them unresponsive to targeted treatments. "This positive CHMP opinion reinforces our efforts to advance the treatment of breast cancer in Europe and expand the use of Keytruda in TNBC to potentially help even more patients with this aggressive disease who are in need of new treatment options," Gursel Aktan, VP of global clinical development at Merck Research Laboratories, said in a statement.

The European Commission is expected to decide in the second quarter whether to grant marketing authorization to this indication in the EU.

This is the third positive opinion that CHMP has issued for Keytruda in the past month. In March, CHMP recommended Keytruda for patients with five types of advanced cancers bearing high microsatellite instability or mismatch repair deficiency, and for PD-L1-expressing cervical cancers.