A combination therapy being developed by MSD and Eisai for kidney cancer has been awarded Breakthrough Designation in the US.
The companies are testing the effectiveness of combining Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced and/or metastatic renal cell carcinoma (RCC).
Interim results from the Phase II trial Study 111 showed that the combination achieved a confirmed objective response rate (ORR) at week 24 of 63 percent, while disease control rate, a secondary endpoint, was 96 percent.
The combination’s Breakthrough designation should give the firms access to more intensive guidance on an efficient drug development programme, access to a regulatory liaison to help accelerate review time and eligibility for rolling review as well as priority review.
“The FDA’s Breakthrough Therapy Designation for the Lenvima and Keytruda combination in advanced and/or metastatic renal cell carcinoma provides us with the opportunity to accelerate our effort to bring an important potential treatment option to these patients,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
In 2012, the number of patients with renal cancer was estimated to be around 338,000 worldwide, including 58,000 in the US, 115,000 in Europe and 17,000 in Japan.
