The safety profiles of CABOMETYX and Opdivo observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.
'We are delighted that this pivotal CheckMate -9ER trial met its key efficacy measures of progression-free survival as well as overall survival for previously untreated kidney cancer patients, with a favorable safety profile. These positive topline results support the growing body of data that shows CABOMETYX may create a more immune-permissive tumor environment that could enhance the response to immune checkpoint inhibitors,' said Dr.
'CheckMate -9ER marks an important milestone in our partnership with
The companies plan to submit detailed results of CheckMate -9ER for presentation at an upcoming medical conference. More information about this trial is available at ClinicalTrials.gov.
About the trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. Patients are randomized 1:1 to Opdivo and CABOMETYX or sunitinib. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients. The trial is sponsored by
About renal cell carcinoma
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year.1 Of these, renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of cases.2 It is twice as common in men, and male patients account for over two thirds of deaths.1 If detected in the early stages, the five-year survival rate is high, but for patients with advanced (aRCC) or late-stage metastatic RCC, the survival rate is much lower, around 12%, with no identified cure for this disease.4,5
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established
Contact:
Tel: +33 (0)1 58 33 67 94
Email: Christian.marcoux@ipsen.com
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