E-Newsletter - August 2016

Positive trial Results for Patients with Previously Untreated Advanced Renal Cell Cancer

Alliance researchers recently announced positive top-line results from Alliance A031203 (the CABOSUN study), a randomized phase II trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC). The trial has met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for cabozantinib compared with sunitinib in patients with advanced intermediate- or poor-risk RCC. The safety data in the cabozantinib-treated arm of the study were consistent with those observed in previous studies in patients with advanced RCC. 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). The final results from CABOSUN will be submitted for presentation at a future medical conference.

“The positive outcome of CABOSUN is extremely exciting, as it marks the very first time that a therapy has shown a progression-free survival benefit over standard of care first-line treatment sunitinib for patients with previously untreated advanced renal cell carcinoma,” said Toni K. Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and chair of the CABOSUN study. “Based on these findings, cabozantinib may have the potential to become a new gold standard for previously untreated patients following their diagnosis with advanced kidney cancer.”

“All of us at the Alliance for Clinical Trials in Oncology are very gratified to have successfully demonstrated the potential of first-line cabozantinib to benefit patients with renal cell carcinoma in the CABOSUN study. This trial exemplifies how NCI-sponsored studies can be efficient, accrue rapidly, and yield results highly relevant to the field,” said Michael J. Morris, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, and chair of the Alliance Genitourinary (GU) Committee.

Exelixis will share the results of CABOSUN with regulatory authorities to discuss potential next steps in the development and submission strategy for cabozantinib as a treatment of first-line advanced renal cell carcinoma. Exelixis is also working closely with clinical advisors on the development plan for cabozantinib in future clinical trials in other genitourinary malignancies.

About Alliance A031203 (CABOSUN Study): Randomized Phase II Study Comparing Cabozantinib (NSC #761968) with Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

CABOSUN is a randomized, open-label, active-controlled phase II trial that was designed to enroll 150 patients with advanced RCC determined to be intermediate- or poor-risk. Between July 9, 2013 and April 6, 2015, 157 patients were randomized 1:1 to receive cabozantinib or sunitinib once daily, four weeks on followed by two weeks off. Seventy-nine patients were on the cabozantinib arm and 78 patients on the sunitinib arm. Patients were stratified by risk status and presence of bone metastases. The primary endpoint was PFS, defined as time from randomization to disease progression or death, whichever occurs first. Positive PFS results have formed the basis for previous regulatory approvals of treatments in the first-line setting, including sunitinib. Secondary endpoints included overall survival and objective response rate.



For other articles in the August issue of the Alliance E-News newsletter, see below.