The past couple of years has seen a number of combination therapies for the first-line treatment of advanced/metastatic renal cell carcinoma (RCC) become available. At the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium in San Francisco this week, ongoing results from the phase 3 CheckMate-9ER clinical trial with the nivolumab plus cabozantinib combination are presented.

With a median follow-up of two years, the nivolumab/cabozantinib continues to show improved cancer shrinkage (response rate), longer treatment time until the drug stops working and tumours start growing again (progression-free survival), and longer overall survival time compared to sunitinib.

The combination doubled median progression-free survival compared to sunitinib (17 months vs. 8.3 months, respectively) and nearly twice as many patients responded to the nivolumab/cabozantinib combination (54.8% vs. 28.4%). The combination resulted in a 34% reduction in the risk of death compared to sunitinib and doubled the number of complete responders (9.3% compared to 4.3% with sunitinib). There was a low number of side effects resulting in patients coming off treatment (6.6%), and no new side effects were identified during the extended follow-up period in the study.

The researchers also looked at 75 patients with sarcomatoid RCC. The nivolumab/cabozantinib combination benefited sarcomatoid patients with a poor prognosis, reducing the risk of death by 64% compared to sunitinib and improving both progression-free survival (10.3 months vs. 4.2 months) and response rate (55.9% vs. 22.0%).

In a separate analysis of the data from CheckMate-9ER, patients treated with the nivolumab/cabozantinib combination report significantly improved health-related quality of life.

Patients from CheckMate-9ER were followed for around 18 months and completed a health-related quality of life questionnaire. Patients treated with the combination of nivolumab and cabozantinib reported improved quality of life with a lower treatment burden, decreased risk of their health getting worse, and a reduction of cancer symptoms compared to sunitinib.

The nivolumab plus cabozantinib combination was approved for the first-line treatment of advanced RCC in America by the Food and Drug Administration (FDA) in January 2021, and is currently being reviewed by a number of health authorities globally.

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