Abiraterone acetate granules for oral suspension demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate in patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Kenneth M. Kernen, MD
Abiraterone acetate granules for oral suspension (TAVT-45) demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate (Zytiga) in patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), meeting the primary end point of the registrational phase 3 TAVT45C02 trial (NCT04887506).
The primary end point comparing serum testosterone levels on day 9 and 10 was met, demonstrating therapeutic equivalence between TAVT-45 and abiraterone acetate. The key secondary end point of a decrease of 50% or greater in prostate-specific antigen levels from baseline at any time over the 84-day treatment period showed no statistical difference between treatment arms. The safety profile of the enhance formulation was similar to that of abiraterone acetate.
The developer of the agent, Tavanta, is planning to present detailed results from the trial at an upcoming medical meeting and submit the findings for publication.
“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,” Andreas Maetzel, MD, PhD, chief medical officer of Tavanta Therapeutics, said in a press release. “Approximately 20% to 30% 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.”
TAVT-45 is reconstituted with water or juice, resulting in an oral suspension to provide an alternative delivery method for the 20% to 30% of patients with dysphagia or have difficulty swallowing large tablets. Additionally, the formulation may result in increased bioavailability, potentially enabling patients to receive a lower dose.
In addition to the multiple large tablets required daily, other limitations of Zytiga include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes. It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients having sub-optimal abiraterone plasma concentrations.
TAVT45C02 is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic and pharmacokinetic effects and safety profile of TAVT-45 compared with abiraterone acetate tablets, in combination with prednisone, in patients with mCRPC and high-risk mCSPC.
“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,” Kenneth M. Kernen, MD, study investigator and partner in the Michigan Institute of Urology, added. “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.”
“We would like to thank the clinical study site investigators and the patients who participated in this pivotal trial,” Lynne Powell, chief executive officer of Tavanta Therapeutics, said. “Tavanta intends to submit our New Drug Application to the U.S. FDA, while also evaluating strategic options for the commercialization of TAVT-45.”
Tavanta Therapeutics Announces Positive Top-line Results from Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer. News release. Tavanta Therapeutics. January 5, 2023. Accessed January 5, 2023. https://prn.to/3QgrwIa