Corina Dutcus, MD from Eisai Inc provided a summary of the findings from a clinical trial evaluating the combination of KEYTRUDA (pembrolizumab) and LENVIMA (lenvatinib) as a first-line treatment for advanced renal cell carcinoma (RCC).
The primary analysis of the study demonstrated a significant improvement in progression-free survival and a meaningful improvement in overall survival, response rate, and complete response rate compared to the standard treatment, Sunitinib.
These positive results led to the approval of the KEYTRUDA plus LENVIMA combination as an established standard of care option for first-line RCC.
With an additional two years of follow-up, the final pre-specified analysis of overall survival data confirmed the robustness of the initial findings. The overall survival rate remained clinically meaningful, showing a 21% reduction in the risk of death compared to Sunitinib.
The progression-free survival response rate and complete response rate were also clinically meaningful, with LENVIMA plus KEYTRUDA demonstrating 2.5 times better progression-free survival and higher response rates compared to Sunitinib.
The mechanism of action of LENVIMA involves targeting VEGF receptors and inhibiting neovascularization, thereby impeding cancer growth and metastasis.
LENVIMA also has direct antitumor activity and, when combined with KEYTRUDA, enhances the immune system’s ability to fight the tumor.
The study showed consistent and robust efficacy across all subgroups of patients, regardless of prognostic factors or disease characteristics.
Adjusting for subsequent anti-cancer medications further demonstrated the benefit of the KEYTRUDA plus LENVIMA combination.
Regarding safety, the combination therapy exhibited a manageable and tolerable safety profile, consistent with the known safety profiles of each individual agent.
No new safety signals emerged, and adverse events were addressed through appropriate interventions.
The overall survival rates observed in the study were highly favorable, with a hazard ratio of 0.71 compared to Sunitinib.
These results were consistent across different subgroups and represented a significant benefit for patients with advanced RCC.
The ongoing collaboration between Eisai and Merck has led to multiple clinical trials exploring the potential of LENVIMA and KEYTRUDA in various cancer types and treatment settings.
The LEAP program has already demonstrated success in renal cell carcinoma and endometrial carcinoma, and additional trials are underway for different tumor types.
The study’s robust and consistent findings have important implications for the standard of care in advanced renal cell carcinoma.
The combination of KEYTRUDA and LENVIMA has shown superior efficacy compared to the standard treatment, providing new hope for patients facing this high unmet medical need.
Dr. Dutcus emphasized Eisai’s commitment to patients and their dedication to oncology research.
They highlighted the collaboration with other pharmaceutical companies and ongoing efforts to explore novel treatment approaches and improve patient outcomes.
In conclusion, the clinical trial data presented at ASCO demonstrate that the combination of KEYTRUDA and LENVIMA offers significant benefits in terms of survival and response rates for patients with advanced renal cell carcinoma.
These findings support the use of KEYTRUDA plus LENVIMA as a first-line treatment option and highlight the potential of this combination therapy in other cancer types and treatment settings.
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