Shares of Exelixis Inc. (NASDAQ: EXEL) slipped on Wednesday after the company reported results from its late-stage trial for advanced hepatocellular carcinoma (HCC). Specifically, this was a pivotal Phase 3 Celestial trial for cabozantinib. Although results were positive, investors sent shares lower.
The study showed that cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival, the trial’s primary endpoint, at the planned second interim analysis for the population of second-line and third-line patients enrolled in this study.
Median overall survival was 10.2 months with cabozantinib, compared with 8.0 months with placebo. Median progression-free survival was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo.
In this trial, 16% of patients in the cabozantinib arm and 3% of patients in the placebo arm discontinued treatment due to treatment-related adverse events.
Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center, New York, and lead investigator on CELESTIAL, commented:
Patients with advanced hepatocellular carcinoma often have a poor prognosis and limited treatment options following prior systemic therapy. The clinically significant benefits in both overall survival and progression-free survival shown in the CELESTIAL trial suggest that, if approved, cabozantinib could become an important addition to the treatment landscape for these patients.
Gisela Schwab, M.D., president, Product Development and Medical Affairs, and chief medical officer, Exelixis, added:
We are excited by the potential benefit cabozantinib may offer to patients with previously treated advanced hepatocellular carcinoma. Given the worldwide prevalence of advanced hepatocellular carcinoma, there is a continued urgency to bring new treatment options to this patient population. We look forward to submitting our supplemental New Drug Application to the FDA for cabozantinib in the first quarter of 2018, and to further advancing our mission to help cancer patients recover stronger and live longer.
Shares of Exelixis traded down more than 8% at $27.12 on Wednesday, with a consensus analyst price target of $33.86 and a 52-week range of $16.72 to $32.50.
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