Merck & Co announces results at ASCO for Keytruda plus Lenvima for kidney cancer patients

Merck & Co – known as MSD outside the US and Canada – has announced that its PD-1 inhibitor Keytruda plus Eisai’s Lenvima improved outcomes versus Pfizer’s Sutent on a measure of health-related quality of life in a phase 3 trial in first-line renal cell carcinoma (RCC) – the most common form of kidney cancer.

The new data, presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, comes from the CLEAR/KEYNOTE-581 study, which is evaluating Lenvima (lenvatinib) plus Keytruda (pembrolizumab) or Novartis’ Afinitor (everolimus) versus Sutent (sunitinib) for the first-line treatment of advanced RCC patients.

Analysis of a secondary endpoints – health-related quality of life (HRQoL) based on patient-reported outcomes – found that Keytruda plus Lenvima demonstrated similar changes from baseline at week 46 on 14 out of 18 HRQoL and disease-related symptoms scores, as well as better HRQoL and disease-related symptoms scores for physical functioning, fatigue, dyspnea and constipation versus Sutent.

In addition, Lenvima plus Afinitor also demonstrated similar changes from baseline at week 46 on 14 out of 18 HRQoL and disease-related symptom scores, as well as a delay in time to first deterioration (TTD) for physical functioning, dyspnea, appetite loss and the EQ-5D visual analog scale compared to Sutent.

“We continue to see an increasing number of patients diagnosed with advanced renal cell carcinoma and remain committed to improving outcomes for those facing this difficult-to-treat disease,” said Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories.

“This new analysis builds on earlier findings from the CLEAR/KEYNOTE-581 trial and further supports the potential use of Keytruda plus Lenvima for the treatment of patients in the first-line setting,” he added.

“This analysis addresses questions of interest to healthcare professionals who treat patients with advanced renal cell carcinoma and reinforces the Keytruda plus Lenvima combination as a possible new treatment option for patients with this disease,” said Takashi Owa, chief medicine creation officer and chief discovery officer, Oncology Business Group at Eisai.

“These results reflect Eisai and Merck’s shared commitment to relentlessly pursue thorough scientific investigations the goal of improving cancer care,” he added.

Previously, Merck and Eisai reported that Keytruda and Lenvima met the primary endpoint of improved progression-free survival (PFS) compared to Pfizer’s Sutent (sunitinib) in first-line advanced RCC patients.

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

When administered alongside Lenvima, Keytruda demonstrated a statistically significant and clinically meaningful improvement on all counts – including PFS, OS and ORR.