LONDON, UK / ACCESSWIRE / October 18, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for Exelixis, Inc. (NASDAQ: EXEL), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=EXEL. The Company announced on October 16, 2017, that its global phase-3 CELESTIAL Trial met its primary endpoint of overall survival (OS). The trial indicated that Cabozantinib provided a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients suffering with advanced hepatocellular carcinoma (HCC). The safety data in the study was also in-line with the established profile of Cabozantinib. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Separately, Exelixis also declared that the U.S. Food and Drug Administration (FDA) granted priority review status for Cabozantinib as a treatment for previously untreated advanced renal cell carcinoma

Hepatocellular Carcinoma, the Most Common Form of Liver Cancer

Liver cancer is known to be the third-leading cause of death worldwide. Approximately 41,000 cases of liver cancer will be diagnosed in 2017 in the US. Of this, Hepatocellular carcinoma (HCC), which is the most common form of liver cancer would account for nearly three-fourths of the total cases. On a global level, around 800,000 new cases of liver cancer are diagnosed every year, of which HCC accounts for over 700,000 deaths each year.

How Cabozantinib Treats HCC?

The tablet formulation of Cabozantinib is CABOMETYX. It basically targets MET, AXL, and VEGFR-1, -2 and -3. In preclinical models, Cabozantinib constrained the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis, and drug resistance. CABOMETYX is available in 20 mg, 40 mg, or 60 mg doses. The recommended dose is 60 mg orally, once daily.

Milestones for Cabozantinib

  • US Food and Drug Administration (FDA) approved CABOMETYX tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy on April 25, 2016.

  • Subsequently, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of Cabozantinib indications outside of the United States, Canada, and Japan in February 2016.

  • Then, the European Commission approved CABOMETYX tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway, and Iceland on September 09, 2016.

  • On January 30, 2017, Exelixis signed an exclusive licensing agreement with Takeda Pharmaceutical Co. Ltd for the commercialization and further clinical development of Cabozantinib for all future indications in Japan, including RCC.
  • However, CABOMETYX is not yet indicated for the treatment of advanced HCC.

  • The FDA granted orphan drug designation to Cabozantinib for the treatment of advanced HCC in March 2017.

CELESTIAL Study Design

CELESTIAL is a randomized, double-blind, placebo-controlled study of Cabozantinib in patients with advanced HCC. It was conducted at over 100 sites globally in 19 countries. The study enrolled 760 patients with advanced HCC, who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function.

In the trial, patients were randomized 2:1 to receive 60 mg of Cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B, or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and macrovascular invasion (yes or no). The study did not provide for any crossover between the study arms.

Primary Endpoint

The primary endpoint for the trial is overall survival while secondary endpoints include objective response rate and progression-free survival. Exploratory end-points include patient-reported outcomes, biomarkers, and safety.

Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90% power to reveal a 32% increase in median OS at the final analysis. Moreover, two interim analyses were also planned and conducted at 50% and 75% of the planned 621 events.

However, the independent data monitoring committee for the study suggested that the trial should be stopped for efficacy, post the review of the second planned interim analysis.

Future Course of Action

  • Exelixis also intends to discuss the trial results with regulatory authorities and determine future steps for the trial. This also includes offering patients, who are presently receiving placebo, the opportunity to shift to Cabozantinib.

  • The Detailed results from the CELESTIAL Trial would be presented at a future medical conference.

Cabozantinib Gets Priority Review Status for Treatment of RCC

Furthermore, Exelixis also announced that the FDA has determined the Company's sNDA for Cabozantinib for patients with previously untreated advanced RCC to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act action date of February 15, 2018. This sNDA is a result of the data from CABOSUN which is a randomized phase-2 Trial that was conducted by The Alliance for Clinical Trials in Oncology. This was done as a part of Exelixis' collaboration with the National Cancer Institute's Cancer Therapy Evaluation Program.

Last Close Stock Review

On Tuesday, October 17, 2017, the stock closed the trading session at $28.30, slipping 2.48% from its previous closing price of $29.02. A total volume of 8.00 million shares have exchanged hands, which was higher than the 3-month average volume of 3.78 million shares. Exelixis' stock price skyrocketed 5.79% in the last three months, 34.51% in the past six months, and 145.87% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have soared 89.81%. The stock is trading at a PE ratio of 149.74. At Tuesday's closing price, the stock's net capitalization stands at $8.31 billion.

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