Exelixis, Inc. (NASDAQ:EXEL) announced positive top-line results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC). The trial 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, M.D., 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, M.D., 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.

“Demonstrating an improvement in progression-free survival with cabozantinib compared to sunitinib as a first-line treatment represents an important milestone for patients with previously untreated RCC,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are thrilled to be a part of the many recent advances in the treatment of advanced kidney cancer and would like to thank the patients, physicians, nurses, caregivers, the Alliance cooperative group and NCI-CTEP who made this clinical trial possible. We look forward to pursuing next steps in the development of cabozantinib in the first-line treatment of patients with advanced RCC and other GU malignancies.” (Original Source)

Shares of Exelixis are currently trading at $5.82, up $0.26 or 4.68%. EXEL has a 1-year high of $6.81 and a 1-year low of $3.08. The stock’s 50-day moving average is $4.69 and its 200-day moving average is $4.70.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on May 15, Leerink Swann analyst Michael Schmidt reiterated a Buy rating on EXEL. Separately, on May 5, Piper Jaffray’s Edward Tenthoff reiterated a Hold rating on the stock and has a price target of $5.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and Edward Tenthoff have a total average return of -0.5% and -8.4% respectively. Schmidt has a success rate of 44.4% and is ranked #2565 out of 3842 analysts, while Tenthoff has a success rate of 30.4% and is ranked #3686.

The street is mostly Bullish on EXEL stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock.

Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib. Exelixis was founded by Corey S. Goodman and Stelios B. Papadopoulos on November 15, 1994 and is headquartered in South San Francisco, CA.