(RxWiki News) The results of a phase III clinical trial have demonstrated that an investigational drug helped advanced kidney cancer patients live as long as those on the current standard therapy.
AVEO Oncology and Astellas Pharma Inc. have announced that overall survival for patients with metastatic (has spread) renal cell carcinoma (RCC) given tivozanib was similar to patients treated with sorafenib (Nexavar).
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The median overall survival (OS) of patients receiving tivozanib was 28.8 months compared to 29.3 months for patients taking sorafenib. So no statistical difference between the the two groups was seen.
For the trial, 517 patients were randomly assigned to receive either 1.5 mg of tivozanib per day (3 weeks on, 1 week off) or 400 mg per day of sorafenib (twice a day, continuously).
The OS data was included in the tivozanib New Drug Application (NDA) filing.
Patients taking sorafenib whose disease progressed were allowed to switch to tivozanib.
OS was the secondary outcome measured by the TIVO-1 trial. Progression-free survival (PFS – the time during which the disease does not get worse) was the study’s primary endpoint.
In previously reported results, PFS in the tivozanib group was 11.9 months compared with 9.1 months in the sorafenib group.
In a statement announcing the results, principal investigator Robert J. Motzer, MD, attending physician, genitourinary oncology service, Memorial Sloan-Kettering Cancer Center, and professor of medicine, Weill Medical College, Cornell University, New York, said, “The safety and efficacy results from TIVO-1 and other clinical trials of tivozanib in advanced RCC suggest it may provide an important new first line treatment option for patients with this aggressive disease.”
The FDA has accepted the tivozanib NDA for filing. Review of the NDA is expected to be complete by July 28, 2013.
Results from this study were presented at the 2013 Genitourinary Cancers Symposium. All research is considered preliminary before it is published in a peer-reviewed journal.
Dr. Motzer is a consultant with Pfizer and receives research funding from AVEO, the manufacturer of tivozanib, GlaxoSmithKline and Pfizer.