Merck Receives Positive EU CHMP Opinion for KEYTRUDA® as Adjuvant Therapy for Renal Cell Carcinoma

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The positive opinion is based on results from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high-risk following nephrectomy and those with resected advanced disease). The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2022.

“Patients in Europe with earlier-stage renal cell carcinoma, who are at increased risk of recurrence following nephrectomy, have not had an approved treatment option in the adjuvant setting that can help reduce the risk of their cancer returning,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “This positive CHMP opinion for KEYTRUDA is an important step forward in bringing adjuvant immunotherapy to these patients and demonstrates Merck’s progress in providing new options to treat earlier stages of cancer.”

Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as several other investigational and approved medicines across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease.