Easy-to-Swallow Drug Being Investigated for Prostate Cancer Treatment

A new treatment for patients with prostate cancer is being investigated in the phase 3 TAVT45CO2 clinical trial, evaluating TAVT-45 (abiraterone acetate granules for oral suspension) in patients with metastatic castration-sensitive prostate cancer and metastatic castration-resistant prostate cancer.

About 20 to 30% of patients with prostate cancer experience difficulty swallowing — also known as dysphagia. Researchers are hoping that TAVT-45, which is an easy-to-consume oral suspension that can be given in water or juice, can offer patients with dysphagia another option besides Zytiga (abiraterone acetate) tablets.

"The current standard of care treatment for metastatic prostate cancer requires patients to ingest multiple large tablets, and under strict fasting conditions due to the risk of increased and highly variable abiraterone exposures with food," said Dr. Kenneth M. Kernen, study investigator and partner in the Michigan Institute of Urology, in a press release.

The study, which recently completed enrollment, includes 107 patients with metastatic castration-sensitive or castration-resistant prostate cancer who will be randomly assigned to receive either TAVT-45 plus prednisone or Zytiga plus prednisone.

The main goal is to determine if there is a difference in testosterone levels on day 9 and day 10. Secondary goals include percentage of patients with a prostate-specific antigen (PSA) decrease of 50% or more from baseline to 84 days; testosterone levels on days 28, 56 and 84; PSA levels at 28,56 and 84 days; concentrations of the drug in the blood at days 9, 28, 56 and 84; and study of what happens when the drugs enter the body (known as pharmacokinetics).

Researchers expect to have study results by the end of 2022. Then, Tavanta Therapeutics, may submit a new drug application to the Food and Drug Administration next year.

"As we work to complete this registrational trial for TAVT-45, we will begin preparing for the submission of our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023, while also evaluating strategic options for commercialization of TAVT-45,” Lynne Powell, CEO of Tavanta Therapeutics, said in a press release.

"Dysphagia is an issue for many – and it occurs more frequently in elderly patients. If TAVT-45 proves successful in this trial, clinicians may soon have access to an alternative, easy-to-drink formulation of abiraterone acetate with improved bioavailability and reduced systemic variability, which may ultimately help patients achieve better clinical outcomes," Kernen said.

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