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Is an Expanded Indication Coming for Excelixis’ Cancer Drug?

Excelixis’ CELESTIAL study met its primary endpoint of improving overall survival in patients with HCC, compared to a placebo.

Is an Expanded Indication Coming for Excelixis’ Cancer Drug?

By: Sarah Massey, M.Sc.

Posted on: in News | Clinical Trial News

San Francisco-based biotech Excelixis has posted positive results for its cancer drug cabozantinib, which may support an expanded indication for the drug in the treatment of advanced hepatocellular carcinoma (HCC). The news has excited investors, with shares in the biotech jumping more than 20 percent after the clinical trail results were announced on Monday.

Excelixis’ CELESTIAL study met its primary endpoint of improving overall survival in patients with HCC, compared to a placebo. The Phase III clinical trial included over 750 HCC patients from 19 countries who had previously been treated with sorafenib, a first-line therapy for this type of cancer.

HCC is the most common form of liver cancer with an estimated 30,750 new cases of the disease being diagnosed this year alone. As the third leading cause of death globally, patients with advanced forms of liver cancer currently face a poor prognosis of less than six months, without treatment.

“We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option,” said Dr. Gisela Schwab, President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “This is an important milestone for the cabozantinib development program; we are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future.”

According to Excelixis, an independent data monitoring committee has recommended that the trial be stopped after completion of the second interim analysis. However, the biotech company may plan to convert the trial to an open-label study to allow patients previously given the placebo the opportunity to receive cabozantinib.

The drug – marketed under the name Cabometyx – has already been approved to treat patients with advanced renal cell carcinoma (RCC). The company plans to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) early next year in the hopes of being granted an expanded indication for the treatment of HCC.


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