French pharmaceutical company Ipsen SA (IPSEY) announced Tuesday that Cabometyx in combination with Opdivo demonstrated continued survival and quality of life benefits with over two years of follow-up in the phase III CheckMate -9ER trial.
The company noted that the two-year follow-up results from analyses of the Phase III CheckMate -9ER trial, which demonstrated sustained survival and response rate benefits, as well as health-related quality of life or HRQoL improvements, with the combination of Cabometyx (cabozantinib) and Opdivo (nivolumab) versus sunitinib in the first-line treatment of advanced renal cell carcinoma or aRCC.
In the U.S., Cabometyx tablets are approved for the treatment of patients with advanced renal cell carcinoma.
CABOMETYX in combination with OPDIVO received FDA approval for the first-line treatment of patients with advanced renal cell carcinoma in January 2021, and the European Commission approved it in March.
These updated results will be featured in two poster presentations at the American Society of Clinical Oncology Genitourinary Cancers Symposium or ASCO GU from February 17 to 19.
With a median follow-up of 32.9 months, Cabometyx in combination with Opdivo continued to show superiority across efficacy endpoints of overall survival, progression-free survival, objective response rate and disease control rate, including increased complete response rates compared to sunitinib.
The company noted that the safety profile identified in the CheckMate -9ER trial was consistent with that previously observed for Cabometyx and Opdivo.
In a separate analysis, with 32.9 months median follow-up, patients continued to report clinically meaningful HRQoL benefits with Cabometyx in combination with Opdivo compared to sunitinib.
Cristina Suarez, a lead investigator on the Phase III CheckMate -9ER trial said, "These new data showcase the possibilities we can offer patients for their advanced disease, presenting the opportunity to significantly reduce their risk of death, and for some patients, achieve a complete response, whilst maintaining quality of life."
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