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Renal cell carcinoma | Kidney cancer | News | Blogs | iPharmaCenter

Updated: Jun 14

November 01, 2023

Keytruda Demonstrated Improvement in Overall Survival in Patients with Renal Cell Carcinoma

Merck has recently unveiled the overall survival outcomes from the Phase 3 KEYNOTE-564 trial, demonstrating the positive impact of Keytruda in patients diagnosed with renal cell carcinoma. The study revealed that when administered as an adjuvant treatment, Keytruda effectively met the significant secondary endpoint of overall survival in patients with this condition, specifically those classified with intermediate-high or high risk of recurrence.

During the pre-specified interim analysis, conducted after a median follow-up duration of 23.9 months, the incidence of disease recurrence or mortality decreased by 32%. Furthermore, the safety profile observed in this trial remained consistent with the established adverse event profile associated with Keytruda.

Merck has emphasized its comprehensive portfolio concerning renal cell carcinoma. Keytruda is undergoing assessments, both as a monotherapy and in combination with other pipeline products and approved medications such as Welireg.


Merck has reported results from the Phase 3 clinical trial named LITESPARK-005, which marks a milestone for their oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan). This trial aimed to determine the efficacy of Welireg in treating adult patients with advanced renal cell carcinoma (RCC) that had progressed following previous PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.

In the LITESPARK-005 trial, Welireg demonstrated a significant improvement in progression-free survival (PFS) versus everolimus. Furthermore, the trial also highlighted a statistically significant enhancement in the trial's secondary endpoint of objective response rate (ORR). While there was a positive trend towards improved overall survival (OS), which was one of the dual primary endpoints, it didn't attain statistical significance in this instance. The analysis of OS will be undertaken in subsequent assessments. The safety profile of Welireg in this study mirrored the findings from prior research.

Welireg is a HIF-2α inhibitor therapy approved in the U.S. and is currently authorized for use in the U.S., Great Britain, Canada, and other countries for the treating von Hippel-Lindau (VHL) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

LITESPARK-005 is part of a comprehensive program to develop Welireg, encompassing four Phase 3 trials in RCC. This includes studies like LITESPARK-011 and LITESPARK-012, examining Welireg in the second-line and treatment-naïve advanced disease settings, as well as LITESPARK-022, which is evaluating Welireg in the adjuvant setting.

The LITESPARK-005 trial, registered under with the identifier NCT04195750, is a randomized and open-label Phase 3 trial comparing Welireg with everolimus. It targeted patients with advanced RCC that had progressed after previous treatment with PD-1/L1 and VEGF-TKI therapies, whether used in sequence or combination. The trial's primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints encompass objective response rate (ORR), duration of response (DOR), safety, and tolerability.

Renal cell carcinoma stands out as the most common variant of kidney cancer, representing approximately 90% of all instances of kidney cancer. It exhibits a higher frequency of diagnosis in men compared to women and is frequently detected as an unintended finding during imaging procedures for various abdominal ailments. Within the United States, around 15% of individuals diagnosed with kidney cancer are identified at an advanced stage of the disease.


Bristol Myers Squibb announced results of the Phase 3 CheckMate -914 trial, testing the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination as an adjuvant treatment in patients with localized renal cell carcinoma (RCC) who have undergone partial or complete removal of kidney and are at risk of reoccurrence. The combination failed to meet the primary endpoint of disease-free survival (DFS).

CheckMate -914 is a Phase 3, placebo-controlled trial. The trial has two parts - Part A evaluating the efficacy of Opdivo plus Yervoy combination, and Part B study in which Opdivo monotherapy is compared with placebo. In both parts, disease-free survival (DFS) was the primary endpoint.

Yearly, 431,000 new cases of renal cell carcinoma are diagnosed every year, and nearly 179,000 deaths are reported worldwide. The 5-year survival rate in patients with advanced, metastatic cancer is 14%.



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