Biotechnology company Exelixis, Inc. (EXEL), reported positive updated interim data from the study of hepatocellular carcinoma patients in the ongoing phase 2 randomized discontinuation trial of cabozantinib.
The results include data from 41 patients with advanced hepatocellular carcinoma with measurable disease at baseline and documented progressive disease per RECIST criteria.
Median Progression-Free survival was 4.4 months and was similar for sorafenib-pretreated and sorafenib-naïve patients. Median overall survival in the 41 patients was 15.1 months.
The week 12 disease control rate - partial response and stable disease at week 12 - was 66 percent. Evidence of objective tumor regression was observed in 78 percent of patients, including those with or without prior sorafenib therapy.
"The progression-free survival and overall survival results observed to date are encouraging," said Dr. Eric Van Cutsem, professor of internal medicine and digestive oncology at the University Hospitals Gasthuisberg, Leuven, Belgium, and senior investigator.
Dr. Van Cutsem added, "It is also interesting that the activity of cabozantinib in this population was irrespective of sorafenib pre-treatment status..."
Exelixis has planned a trial to evaluate cabozantinib in a second-line randomized phase 2 trial in HCC under an agreement with the National Cancer Institute's Cancer Therapy Evaluation Program. The trial is expected to help prioritize the development of cabozantinib in HCC in the context of the multiple indications in which the compound appears to provide clinical benefit.
Dr. Michael Morrissey, CEO Exelixis said, "These interim data are encouraging and support the potential utility of cabozantinib in the treatment of HCC."
The tolerability of cabozantinib in patients with HCC was similar to that of other tyrosine-kinase inhibitors. The most frequently reported adverse events, "regardless of causality in the 41 patients in the HCC cohort," included diarrhea, hand-foot syndrome, thrombocytopenia, aspartate aminotransferase increase, asthenia, hypertension, fatigue, nausea, vomiting, and weight decrease. No grade 5 events related to cabozantinib and no clinically significant bleeding was reported.
Cabozantinib is an investigational agent that provides coordinated inhibition of metastasis and angiogenesis to kill tumor cells while blocking their escape pathways. The therapeutic role of cabozantinib is currently studied across several tumor types.
The data was made available at the American Society of Clinical Oncology 2012 Annual Meeting in Chicago, Illinois.
EXEL last traded at $4.49, up $0.02 or 0.34%, on a volume of 1.12 million shares on the Nasdaq.
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