European Commission Approves KEYTRUDA (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment

On May 24, 2022

Merck, known as MSD outside the United States and Canada, announced that 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 (TNBC) at high risk of recurrence.

The approval is 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% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) compared to neoadjuvant chemotherapy alone in this patient population. Median follow-up time for all patients was 37.8 months (range, 2.7-48).

KEYNOTE-522 was the first large, randomized Phase 3 study to report a statistically significant and clinically meaningful EFS result among patients with stage II and III TNBC. With this decision, this KEYTRUDA combination becomes the first immunotherapy option approved for patients in the European Union (EU) in this setting.

“Triple-negative breast cancer has a high risk of recurrence within the first five years, so it’s meaningful for patients to have access to new therapies that can reduce the risk of disease progression,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. “The approval of this KEYTRUDA regimen marks a turning point for patients with high-risk early-stage TNBC, as they now have an immunotherapy option in early stages of the disease that has demonstrated significant improvements in pathological complete response and event-free survival compared to neoadjuvant chemotherapy.”

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.

“KEYTRUDA was first approved in Europe to address an unmet need in certain patients with metastatic TNBC, and today’s approval extends the use of KEYTRUDA to more patients facing this difficult-to-treat cancer – this time in earlier stages of TNBC,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are very proud that today’s approval marks the fifth indication for KEYTRUDA in Europe for patients with breast or a gynecological cancer, an important area where patients need continued research and innovation.”

This approval allows marketing of this 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.

Merck is committed to delivering meaningful advances in gynecologic and breast cancers to patients around the world through its extensive clinical development program across its oncology portfolio of investigational and approved medicines. Within just the last year, KEYTRUDA has been approved in Europe for five new indications across breast, cervical and endometrial cancers as monotherapy and in novel combinations.