(RxWiki News) Right now, there are only a handful of drugs that are approved to treat advanced renal cell carcinoma – a type of kidney cancer. Phase 3 clinical trial results of another drug suggest kidney cancer patients may soon have a new option.
The drug currently going through the clinical trial process – tivozanib – has been shown to be safe for patients with advanced kidney cancer.
Compared to sorafenib (sold under the brand name Nexavar) this new drug had fewer serious side effects, patients stayed on the medication longer and fewer dosage changes were needed during therapy.
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AVEO Oncology and Astellas Pharma Inc. presented data from the Phase 3 trial on October 1 at ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria.
Timothy Eisen, PhD, FRCP, study investigator at Cambridge University Health Partners, said in a press release, “The data from TIVO-1 show that treatment with tivozanib led to fewer side effects and lower rates of dose modifications than with sorafenib. This suggests that it is easier to maintain full dose therapy with tivozanib.”
The TIVO-1 trial compared safety and how well patients tolerated tivozanib and sorafenib in 517 patients with advanced renal cell carcinoma (RCC).
According to study results presented at the American Society of Clinical Oncology (ASCO) Annual Meeting earlier in the year, tivozanib provided patients a longer period of time during which the disease didn’t get worse – progression-free survival (PFS).
Patients treated with tivozanib had a median PFS of 11.9 months, compared to 9.1 months for patients taking sorafenib.
For some patients who had not been previously treated for their cancer, PFS on tivozanib was even longer – a median of 12.7 months. According to the companies, this is the first therapy to show a median PFS of longer than one year.
Additionally, compared to patients receiving sorafenib, those on tivozanib:
- Had lower rates of dosage changes, interruptions or discontinuations
- Drug-related adverse events (AE) occurred in fewer patients taking tivozanib than patients on sorafenib - 67.6% vs. 83.3%.
- The most common AE for tivozanib was hypertension and for sorafenib, hand-foot syndrome.
On September 28, AVEO submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for tivozanib to treat advanced RCC.
Sorafenib is approved to treat advanced RCC and unresectable hepatocellular carcinoma - a type of liver cancer that cannot be treated with surgery.
Research is considered preliminary before it is published in a peer-reviewed journal.