Cabozantinib decreases the risk of disease progression or death compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC), according to updated results from the CABOSUN (CABOzantinib versus SUNitinib) phase 2 trial presented at the European Society for Medical Oncology 2017 Congress in Madrid.

For the open-label trial, investigators randomly assigned 157 patients with intermediate- or poor-risk advanced RCC to receive cabozantinib 60 mg once daily (79 patients) or sunitinib 50 mg once daily, 4 weeks on followed by 2 weeks off (78 patients).

The latest analysis, presented by Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, included an assessment by a blinded independent radiology review committee showing that cabozantinib was associated with a clinically meaningful and statistically significant 52% decreased risk of disease progression or death compared with sunitinib, the current standard of care for the first-line treatment of advanced RCC. Median progression-free survival (PFS) was 8.6 months for cabozantinib-treated patients compared with 5.3 months for sunitinib recipients, a statistically significant 3.3 month difference between the groups.

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“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,” Dr Choueiri said.

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He noted that patients in the trial had a notable number of other independent adverse prognostic risk factors. These included a high rate of bone metastases, 2 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,” he said.

To be included in the trial, patients needed to have locally advanced or metastatic clear-cell RCC, an ECOG performance status of 0–2, intermediate- or poor-risk disease based on IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) criteria.


Choueiri TK, Hessel C, Halabi S, et al. Progression-free survival (PFS) by independent review and updated overall survival (OS) results from Alliance A031203 trial (CABOSUN): cabozantinib versus sunitinib as initial targeted therapy for patients (pts) with metastatic renal cell carcinoma (mRCC). Data presented at the European Society for Medical Oncology 2017 Congress in Madrid, Spain. Abstract LBA39.