MSD announce new data from advanced renal cell carcinoma trial
pharmafile | June 8, 2021 | News story | Manufacturing and Production | MSD, rcc
Merk (MSD) has announced positive data from its Phase III Clear/Keynote-581 trial on Keytruda (pembrolizumab) plus Lenvima (lenvatinib), 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-581 trial, Keytruda plus Lenvima and Lenvima plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC.
Dr Robert Motzer, Medical Oncologist, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, 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.”
Keytruda plus Lenvima demonstrated similar changes from baseline at mean follow-up (week 46) on 14 out of 18 HRQoL and disease-related symptom scores and better HRQoL and disease-related symptom scores for the following measures:
- Physical functioning
- Fatigue
- Dyspnea
- Constipation
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 and worse HRQoL and disease-related symptom scores compared to sunitinib in the following measures:
- Global Health Score/Qol
- Pain
- Appetite loss
- Diarrhoea
Dr Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, said: “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.
“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.”
In 2020 it was estimated that there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease worldwide. In the US there will be nearly 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021.
RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients with metastatic disease.
Kat Jenkins
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