• Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib;
• CABOMETYX in combination with Opdivo demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile;
• Trial co-funded by Bristol Myers Squibb, Exelixis, Ipsen and Takeda.
Ipsen announced today that CheckMate -9ER, a pivotal Phase III trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).
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. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We look forward to discussing these results with global health authorities with the aim to bring this new combination regimen to previously untreated kidney cancer patients, a population that, despite recent advances, remains in need of additional therapeutic options that extend survival.”
“CheckMate -9ER marks an important milestone in our partnership with Exelixis to further develop CABOMETYX® and our shared vision to progress the treatment for cancers and indications with high unmet need. If approved, this combination may become an important new first-line option for patients with this cancer,” said Bartek Bednarz, Senior Vice President, Global Product & Portfolio Strategy at Ipsen. “We would like to thank the patients, their families and the healthcare professionals involved in the trial and we look forward to presenting detailed results of the study at an upcoming congress.”
For more information on the details of the trial results, please see the Exelixis Form 8-K on file here.
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 Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.
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 products
This press release mentions investigational uses of Ipsen products. Product indications and approvals for use vary by jurisdiction; please see SmPC/PI for full indications and safety information.
Ipsen (ipsen.com) 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 Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,800 employees worldwide.
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1. GLOBOCAN 2018. Kidney Cancer Factsheet. Last accessed: April 2020.
2. Mayo Clinic. Kidney Cancer. Last accessed: April 2020.
3. National Cancer Institute. Renal Cell Cancer. Last accessed: April 2020.
4. American Cancer Society. Survival rates for kidney cancer. Last accessed: April 2020.
5. Renal cell carcinomas epidemiology in the era of widespread imaging. Journal of Clinical Oncology.