Phase III of the CheckMate -9ER trial has reached its primary endpoint of progression free survival in those with advanced or metastatic renal cell carcinoma. This study was evaluating CABOMETYX combined with Opdivo. Not only did these drugs meet the primary endpoint, but they also reached the secondary endpoints of overall survival and objective response rate.
About Renal Cell Carcinoma
Renal cell carcinoma is a form of kidney cancer that often spreads to other organs, such as the lungs. It is the most common form of kidney cancer in adults, typically affecting males between the ages of 50 and 70. It results in symptoms including abdominal pain, weight loss, blood in the urine, discolored urine, fever, issues with vision, high blood pressure, fatigue, and enlarged testicles. The cause of this cancer is unknown, but it has been linked to smoking, prior kidney problems, and certain genetic mutations.
It is diagnosed through a CT scan, abdominal ultrasound, and blood and urine tests. It is best if the diagnosis comes early, so that treatment may begin as soon as possible. Surgery to remove the kidney, bladder, and surrounding tissue is typically the first step of treatment. Chemotherapy, ablation, and hormone treatments may also be used. Other treatments include sorafenib, proleukin, and afinitor.
About the Trial
The CheckMate -9ER trial was a randomized, open-label, multi-national Phase III trial. Half of patients were given CABOMETYX in combination with Opdivo, while the other half were given sunitinib. It met all of its endpoints: progression free survival, overall survival, and objective response rate. It maintained a positive safety profile from prior phases as well.
The success of this trial shows that patients with metastatic or advanced renal cell carcinoma may soon have another treatment option.
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