Merck, Eisai’s Keytruda plus Lenvima combo hits the mark in renal cancer

Merck & Co/MSD and Eisai’s Keytruda plus Lenvima combination has scored positive top-line results from a phase 3 trial in advanced renal cell carcinoma (a form of kidney cancer).

The results, from the KEYNOTE-581/CLEAR trial, demonstrated that Keytruda (pembrolizumab) and Lenvima (lenvatinib) met the primary endpoint of improved progression-free survival (PFS) compared to Pfizer’s Sutent (sunitinib) in first-line advanced renal cell carcinoma (RCC) patients.

The combination treatment also met key secondary endpoints of overall survival (OS) and objective response rate (ORR).

According to Merck and Eisai, when administered alongside Lenvima, Keytruda demonstrated a statistically significant and clinically meaningful improvement on all counts – including PFS, OS and ORR.

In a separate arm of the KEYNOTE-581 trial, the partner companies also evaluated Lenvima plus Novartis’ Afinitor (everolimus) in advanced RCC, with this combination also topping Sutent on PFS and ORR.

“The results for Keytruda plus Lenvima versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of Keytruda-based combinations for the first-line treatment of advanced renal cell carcinoma,” said Gregory Lubiniecki, associate vice president, oncology clinical research, Merck Research Laboratories.

Merck already has approval for another combination treatment, Keytruda plus Inlyta (axitinib), for the first-line treatment of advanced RCC.

In addition to Merck and Eisai, Bristol Myers Squibb (BMS) also has a new potential advanced RCC treatment in the form of a combination treatment containing its checkpoint inhibitor Opdivo (nivolumab)and Exelixis’ tyrosine kinase inhibitor Cabometyx (cabozantinib).

Data presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress detailed a 40% reduction in the risk of death among previously untreated RCC patients receiving Opdivo plus Cabometyx compared to Sutent (sunitinib).

The combination also met the primary trial endpoint of achieving a statically significant improvement in progression-free survival (PFS), with Opdivo plus Cabometyx hitting a median PFS of 16.6 months compared to 8.3 months for Sutent.

The Opdivo/Cabometyx combination also demonstrated a superior objective response rate when compared to Sutent, with almost twice as many patients responding to BMS’ treatment compared to Pfizer's – 56% and 27%, respectively.

The detailed data from Merck and Eisai’s KEYNOTE-581 trial is set to be presented at an upcoming medical meeting – hopefully, the full dataset will shine some light on the comparative benefit of the Keytruda/Lenvima combination against its competitors.