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Ipsen and Exelixis have announced updated results from the phase 2 CABOSUN trial of cabozantinib (Cabometyx) compared to sunitinib (Sutent) in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease. The results were presented at the European Society for Medical Oncology (ESMO) 2017 congress, which is being held in Madrid, Spain this week.
The updated results included an analysis from a blinded independent radiology review committee (IRC), which confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS), as well as an updated investigator-assessed analysis. The IRC confirmed that cabozantinib reduced the rate of disease progression or death by 52% compared to sunitinib, and this result was both clinically meaningful and statistically significant. The median progression-free survival (PFS) for cabozantinib was 8.6 months versus 5.3 months for sunitinib, corresponding to a 3.3 month (62%) improvement by cabozantinib compared to sunitinib.
“These updated analyses from CABOSUN consistently show that cabozantinib provided a statistically significant decrease in the rate of disease progression or death compared to sunitinib, a current standard of care – potentially offering a new treatment option for physicians to treat patients in the first-line advanced renal cell carcinoma setting,” said Dr Toni K. Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “The CABOSUN trial included patients with intermediate or poor prognostic factors per the IMDC criteria; in addition, patients had a notable number of other independent adverse prognostic risk factors. These included a high rate of bone metastases, two or more sites of metastatic disease, ECOG 2 performance status, and lack of prior nephrectomy. This patient population fares poorly and is in need of new therapies to better control their disease.”
CABOSUN is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).