The
'Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world. We're proud to be able to share that the CHMP has confirmed a positive recommendation for Cabometyx in combination with Opdivo, bringing this impactful new treatment option one step closer for patients,' said
The CHMP adopted the positive opinion based on results from the pivotal Phase III CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib, with consistent efficacy benefits observed across key subgroups of patients.1 Cabometyx combined with Opdivo was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor (TKI) components in first-line advanced RCC.1 The full data from the CheckMate -9ER trial were presented during a Presidential Symposium at the
Ipsen and its partners have shared the CheckMate -9ER data with regulatory authorities around the world. The combination of Cabometyx and Opdivo was approved by the
'Today's news is welcomed by physicians treating people living with advanced renal cell carcinoma,' said Dr.
About renal cell carcinoma
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year.4 Of these, renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of cases.5,6 It is twice as common in men, and male patients account for over two thirds of deaths.4 If detected in the early stages, the five-year survival rate is high, but for patients with advanced or late-stage metastatic RCC the survival rate is much lower, around 12%, with no identified cure for this disease.7,8
About the CheckMate -9ER trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1 1%) were randomized to Cabometyx plus Opdivo (n= 323) versus sunitinib (n= 328). 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 Cabometyx (cabozantinib)
Cabometyx is currently approved in 57 countries, including in the
The detailed recommendations for the use of Cabometyx are described in the Summary of Product Characteristics (SmPC) and in the
Cabometyx is marketed by
About Ipsen
Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established
Ipsen-Cautionary Note Regarding Forward-Looking Statements
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