Merck’s Keytruda Bags FDA Approval for Early Kidney Cancer in Adjuvant Setting

November 18th, 2021- Kenilworth, NJ-based Merck has bagged yet another FDA approval for its blockbuster anti-PD1 therapy, Keytruda, this time for early kidney cancer. Early today, the Pharma giant announced that the agency has approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence.

“With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients,” said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School in a statement.

With this, Keytruda has become the first immunotherapy approved for the adjuvant treatment of certain patients with RCC.

“This milestone is a testament to our commitment to help more people living with cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Keytruda is foundational for the treatment of patients with certain advanced cancers, and this approval marks the fourth indication for Keytruda in earlier stages of cancer.”

KEYNOTE-564 Trial

RCC is the most common type of kidney cancer, which is twice as common in men as in women. In 2021 alone, it is estimated that there will be approximately 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease.

The approval is based on encouraging data from KEYNOTE-564, a Phase 3 trial that evaluated the drug as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED).

Results showed that Keytruda demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo. 

“Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence. In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence,” Dr. Choueiri said.

Merck is exploring Keytruda, both as monotherapy and combo therapy, across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease. Just three months ago, Merck received approval from the FDA for its Keytruda and Lenvima combo for the first-line treatment of advanced RCC. With the latest approval for Keytruda in the adjuvant setting for early kidney cancer, the company is looking at a new billion-dollar market.

Author

Rajaneesh K. Gopinath