Easy-to-Swallow Drug Shows Similar Results to Zytiga in Patients With Metastatic Prostate Cancer

Patients with metastatic castration-resistant prostate cancer who were treated with TAVT-45 (abiraterone acetate) — a type of abiraterone acetate that can be mixed with water or juice, making it easy to swallow — had similar outcomes to those treated with Zytiga, the tablet form of the drug, according to findings from a phase 3 trial, TAVT45C02.

The results, which were published by TAVT-45’s manufacturer, Tavanta Therapeutics, showed that there were similar serum testosterone levels at day nine and day 10 of treatment for patients treated with TAVT-45 plus prednisone and Zytiga plus prednisone. Additionally, there was no statistical difference in prostate-specific antigen (PSA) levels over the 84-day treatment period between the two groups.

"The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga®, benefitting many patients with dysphagia or difficulty swallowing large tablets," said Dr. Andreas Maetzel, chief medical officer of Tavanta Therapeutics, in a company-issued press release.

Patients with cancer may experience difficulty swallowing for a variety of reasons, from treatment-related mouth sores and dry mouth to tumors in the throat or motor function problems, according to the American Cancer Society.

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"Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing pills and capsules We believe these patients may benefit from an alternate formulation like TAVT-45 that would allow them to take their much-needed medications in an easier-to-take formulation,” Maetzel said.

Regarding safety, the side effects seen with TAVT-45 were similar to those observed with Zytiga.

"It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone acetate as a standard of care in the treatment of metastatic prostate cancer," said Dr. Kenneth M. Kernen, study investigator and partner in the Michigan Institute of Urology in the release. "The positive results from this clinical study further support and validate the use of TAVT-45 as a novel, oral, easy-to-drink formulation of abiraterone acetate. As a physician, this would be a welcome potential treatment alternative that may also help patients adhere to their medication regimens and may ultimately improve clinical outcomes."

Tavanta Therapeutics plans on presenting more data from TAVT45C02 at an upcoming medical meeting.

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