Abiraterone acetate is a drug commonly used in conjunction with prednisone for the treatment of prostate cancer that has metastasized to other areas of the body. The drug is available in tablet form and has recently been developed as an oral suspension—known as TAVT-45—by Tavanta Therapeutics.
Approximately 20% to 30% of patients with prostate cancer experience dysphagia, or difficulty swallowing. As an oral suspension, TAVT-45 can serve as a substitute for the tablet formulation of abiraterone acetate and help these patients receive the medication they need in an easy-to-swallow format. The recent global, randomized, multicenter, open-label phase 3 clinical trial, TAVT45C02, evaluated the safety and efficacy of TAVT-45 compared with the tablet formulation when combined with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) or high-risk metastatic castration-sensitive prostate cancer (mCSPC).
Patients who took part in the TAVT45C02 trial had pathologically confirmed diagnosis of adenocarcinoma of the prostate and were randomly assigned to receive either TAVT-45 granules for oral suspension 250 mg twice a day or abiraterone acetate tablets 500 mg once a day. Patients with mCSPC were also given prednisone 5 mg once a day, and patients with mCRPC were given prednisone 5 mg twice a day.
The primary end point of the trial was reached, as TAVT-45 was found to have comparable serum testosterone levels at days 9 and 10 of treatment compared with abiraterone acetate tablets. The key secondary end point of reducing prostate-specific antigen levels by 50% or more from baseline did not show a statistical difference between TAVT-45 and the tablet formulation. The safety profile of TAVT-45 was also consistent with the profile reported with abiraterone acetate tablets, showing that TAVT-45 is a safe and therapeutic equivalent to the tablet formulation.
“It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone as a standard of care in the treatment of metastatic prostate cancer,” study investigator Kenneth M. Kernen, MD, a partner at the Michigan Institute of Urology, said in Tavanta Therapeutic’s press 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.”