Merck Releases New Data From Late-stage Study Of Clear/Keynote-51

Merck (MRK) announced new data from the pivotal phase 3 study dubbed, Clear/Keynote-51, evaluating the combinations of Merck's Keytruda, plus Eisai's Lenvima and Lenvima plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In an analysis of a secondary endpoint of health-related quality of life (HRQoL) scores in the Clear/Keynote-51 study, Keytruda plus Lenvima and Lenvima plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC.

Results from the analysis showed Keytruda plus Lenvima and Lenvima plus everolimus demonstrated similar changes from baseline at mean follow-up (Week 46) on 14 out of 18 HRQoL and disease-related symptom scores compared to sunitinib.

"KEYTRUDA plus LENVIMA demonstrated a similar TTD in 14 out of 18 HRQoL and disease-related symptom scores, and a delay in TTD for physical functioning, dyspnea, appetite loss, and EQ-5D visual analog scale compared to sunitinib. KEYTRUDA plus LENVIMA demonstrated a delay in TUDD in 16 out of 18 HRQoL and disease-related symptom scores and a similar TUDD for cognitive functioning and financial difficulties compared to sunitinib," Merck said.

"The additional data showed an improvement of specific health-related quality of life measures for patients who received KEYTRUDA plus LENVIMA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients," said Dr. Robert Motzer, Medical Oncologist, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center.

Data from the Clear/Keynote-51 study are currently under review with the FDA.

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