US clears Keytruda, Lenvima combo in first-line kidney cancer

The FDA announced Wednesday that it approved the combination of Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) and Eisai's oral multi-kinase inhibitor Lenvima (lenvatinib) as a first-line treatment for adults with advanced renal cell carcinoma (RCC). Gregory Lubiniecki, who heads oncology clinical research at Merck Research Laboratories, said the decision "reinforces the potential" of Keytruda plus Lenvima, a combination that is now approved for two different cancer types, with the FDA having signed off on its use in advanced endometrial carcinoma only last month.

The latest approval is based on results from the pivotal Phase III CLEAR trial, also referred to as KEYNOTE-581, in which Keytruda plus Lenvima led to significant improvements on the efficacy outcome measures of progression-free survival (PFS), overall survival (OS) and confirmed objective response rate, compared to Pfizer's Sutent (sunitinib).

Earlier this year, Merck and Eisai reported CLEAR study data showing the combination had reduced the risk of disease progression or death by 61% in first-line advanced RCC patients, who achieved a median PFS of 23.9 months, versus 9.2 months for those given Pfizer's drug. Regarding OS, Keytruda and Lenvima cut the risk of death by 34% versus Sutent, with median OS not reached in either arm.

Expands individual RCC labels

The FDA decision marks a broadening of both drugs' existing RCC labels, and moves Lenvima into the first-line setting. Keytruda was already approved in the US in combination with Pfizer's Inlyta (axitinib) for the first-line treatment of adults with advanced RCC, while Lenvima was cleared for use together with everolimus for advanced RCC patients following one prior anti-angiogenic therapy.

Merck recently reported that Keytruda sales were up 23% in the second quarter to $4.2 billion, boosted in part by ongoing launches in head and neck squamous cell carcinoma and kidney cancer. Meanwhile, Eisai said that in its most recent quarter, Lenvima generated JPY 44.2 billion ($400 million), which was up around 27% from the year-ago period.