Merck and Eisai have reported that investigational data from the pivotal Phase III CLEAR study (KEYNOTE-581/Study 307) of the Keytruda and Lenvima combination demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) in first-line advanced renal cell carcinoma (RCC) patients.

Keytruda is Merck’s anti-PD-1 therapy while Lenvima is the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

The Phase III, multi-centre, randomised, open-label trial analysed Lenvima in combination with Keytruda or everolimus versus sunitinib for the first-line treatment of patients with advanced RCC.

The trial had 1,069 participants who were randomised to one of three treatment arms.

They received Lenvima (20mg orally once daily) plus Keytruda (200mg intravenously every three weeks) or Lenvima (18mg orally once daily) plus everolimus (5mg orally once daily) or Sunitinib (50mg orally once daily for four weeks on treatment, followed by two weeks off treatment).

The trial’s primary endpoint is PFS while major secondary endpoints are overall survival (OS), objective response rate (ORR) and safety.

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Data showed that Keytruda plus Lenvima significantly lowered the risk of disease progression or death by 61% as compared with sunitinib, with a median PFS of 23.9 months versus 9.2 months for sunitinib.

In the trial’s key secondary endpoints, the combination lowered reduced the risk of death by 34% versus sunitinib arm. The combination treatment also resulted in an ORR of 71% versus 36.1% in the sunitinib arm.

Furthermore, Lenvima plus everolimus also showed statistically significant improvements in PFS and ORR as compared with sunitinib.

The safety profiles of both Keytruda plus Lenvima and Lenvima plus everolimus were in line with previously noted ones.

Merck Research Laboratories Oncology Clinical Research vice-president Dr Gregory Lubiniecki said: “In this trial, Keytruda plus Lenvima demonstrated superior efficacy benefits compared with sunitinib.

“If approved, we believe this combination has the potential to be an important new treatment option for patients with advanced renal cell carcinoma in the first-line setting.”

Earlier this month, Merck reported data from Phase III KEYNOTE-598 trial.