A combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) and Pfizer’s tyrosine kinase inhibitor Inlyta (axitinib) has been found to reduce risk of death by nearly half compared to sunitinib as first-line treatment for advanced renal cell carcinoma (RCC).
The results are taken from the pivotal Phase III KEYNOTE-426 trial, and show that the combination is the first regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib.
The dual primary endpoints of the study were OS and PFS; key secondary endpoints include ORR, safety, duration of response, PFS at 12, 18 and 24 months and OS at 12, 18 and 24 months.
Findings from the first interim analysis show that the drug combination cut the risk of death by 47%, and that the ORR was 59.3% for patients who received the combination.
The US Food and Drug Administration (FDA) has already granted priority review for a supplemental Biologics License Application (sBLA) for Keytruda in combination with Inlyta for the first-line treatment of patients with advanced RCC, with a set target action date of June 20, 2019.
“Historically, patients with advanced RCC have faced five-year survival rates of less than 10 percent. Given the aggressive nature of this disease and the poor long-term prognosis, these new survival data with Keytruda in combination with axitinib from KEYNOTE-426 offer the potential of a new treatment option for patients with advanced renal cell carcinoma,” said Dr Thomas Powles, lead investigator for KEYNOTE-426, professor of genitourinary oncology, lead for Solid Tumour Research at Barts Cancer Institute, and director of Barts Cancer Centre.
Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of ten kidney cancers are RCCs and the disease is about twice as common in men as in women.