Exelixis, Inc. EXEL and Ipsen announced positive detailed results from the pivotal phase III CELESTIAL study of Cabometyx (cabozantinib) demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma (HCC).
CELESTIAL study met its primary endpoint and cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival (OS). The median OS was 10.2 months with Cabometyx compared with 8.0 months with placebo. The Median progression-free survival (PFS) more than doubled, at 5.2 months with Cabometyx compared with 1.9 months with placebo. The trial showed that disease control (partial response or stable disease) was achieved by 64% of the Cabometyx group compared with 33% of the placebo group. The companies plan to present the results at a symposium in San Francisco later this week.
We remind investors that Cabometyx is already approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. In December 2017, the FDA approved label expansion of Cabometyx for the treatment of previously untreated RCC. The approval came on the back of positive results from the randomized phase II, trial CABOSUN on first-line kidney cancer. The results demonstrated statistically significant and clinically meaningful improvement in PFS versus Pfizer Inc.’s PFE Sutent.
Exelixis’ share price has increased 64.5% over a year compared with the industry’s gain of 2.6%.
HCC is the most common form of liver cancer, accounting for more than 90% of cases in the United States. Hence there is a dire need to bring new treatment options. Exelixis plans to submit a supplemental new drug application to the FDA in the first quarter of 2018.
Cabometyx raked in strong sales in the first nine months of 2017, courtesy of the increasing demand for the drug. A potential approval will further boost the sales of the drug. .
Exelixis has also initiated a phase Ib study (investigator-sponsored) on Cabometyx (in combination with Bristol-Myers Squibb Company’s BMY Opdivo (nivolumab) or Opdivo plus Yervoy) in patients suffering from genitourinary tumors, including bladder cancer and RCC.
Exelixis has also inked agreements with Bristol-Myers Squibb and Roche Holding AG RHHBY to develop cabozantinib in combination with immunotherapy agents.
January 17, 2018