Reuters Health Information (2014-01-17): Panel favors continuation of tivantinib study for liver cancer
Drug & Device Development
Panel favors continuation of tivantinib study for liver cancer
Last Updated: 2014-01-17 10:34:16 -0500 (Reuters Health)
(Reuters) - ArQule Inc said an independent committee recommended a late-stage study of the company's cancer drug continue with a lower dose, months after liver cancer patients who received a greater dose showed a higher incidence of a blood disorder.
A lower dose of the company's drug, Tivantinib, reduced the incidence of a low white blood cell count, ArQule said on Thursday citing a recent review of safety data.
Tivantinib is an orally bioavailable small molecule inhibitor of c-Met with potential antineoplastic activity. The protein c-Met is overexpressed or mutated in many tumor cell types and plays key roles in tumor cell proliferation, survival, invasion, and metastasis, and tumor angiogenesis.
The drugmaker and its partner Daiichi Sankyo Inc are testing the drug as a treatment for patients with previously treated hepatocellular cancer, the most common type of liver cancer.
A Data Monitoring Committee recommended last September that the drug's dosage be reduced from 240 mg twice daily to 120 mg, and that patients be monitored to confirm the safety profile of the lower dose.
The drug, however, failed to show statistically significant improvement in overall survival in another late-stage trial in patients suffering from a type of lung cancer, ArQule said.