Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.
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At times it seems as if Merck’s checkpoint inhibitor, Keytruda, is being approved for just about every type of cancer. And it certainly is an effective drug in a broad range of indications. The most recent U.S. Food and Drug Administration (FDA) approval for Merck’s anti-PD-1 checkpoint inhibitor is in combination with Pfizer’s chemotherapy Inylta (axitinib) as first-line treatment for advanced renal cell carcinoma (RCC).
The approval was based on results from the pivotal Phase III KEYNOTE-426 clinical trial. It showed significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for the combination compared to Pfizer’s Sutent (sunitinib). The results were consistent over a number of pre-specified subgroups, risk categories and PD-L1 expression levels.
“This represents a new treatment option for patients with advanced renal cell carcinoma, who will now have access to Keytruda as part of a first-line combination regimen,” stated Scot Ebbinghau, vice president, clinical research, Merck Research Laboratories. “Today’s approval reflects Merck’s commitment to patients with cancer and further supports the use of Keytruda to help improve survival outcomes for patients with advanced renal cell carcinoma.”
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. It is a common form of kidney cancer. Approximately 90% of all kidney cancers are renal cell carcinomas. It usually starts as a tumor growing in one kidney but can develop in both kidneys. It is more common in men than in women.
KEYNOTE-426 looked at 861 patients who had not previously received systemic therapy for advanced RCC. They were enrolled with no regard for PD-L1 tumor expression. They were randomized by International Metastatic RCC Database Consortium (IMDC) risk categories (favorable versus intermediate versus poor) and geographic region. The regional divisions were North America versus Western Europe versus “Rest of the World.”
Patients were ineligible who had active autoimmune disease that required systemic immunosuppression within the last two years.
On an equal basis, patients were randomized to receive Keytruda 200 mg intravenously every three weeks up to 24 months in combination with 5 mg of oral axitinib twice daily or 50 mg orally once daily for four weeks of Sunitinib and then off treatment for two weeks.
Based on data reported in February, about 90% of patients who received the Keytruda/Inlyta combination were alive after 12 months, compared to about 78% who were alive after a year when treated with Sutent.
The approval was about two months ahead of its target action date. Cowen analyst Yaron Werber wrote in a note to clients that this should allow the combination therapy a head start over rival products. The primary competition for this indication is Bristol-Myers Squibb’s combination of Opdivo and Yervoy, which is presently the gold standard for previously untreated advanced kidney cancer.
Keytruda is expected to raise more than $10 billion in sales this year.
“Given the aggressive nature of the disease, many patients with advanced renal cell carcinoma need additional treatment options that can help improve survival outcomes,” stated Brian Rini, medical oncologist at Cleveland Clinic Cancer Center and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. “Pembrolizumab in combination with axitinib offers an important new therapeutic option for physicians to consider when approaching initial treatment for patients newly diagnosed with advanced renal cell carcinoma.” Rini reports consulting and research funding from Merck.
