TAVT-45 Demonstrates Therapeutic Equivalence to Abiraterone Acetate Tablets in Metastatic Prostate Cancer

Article

Patients with metastatic prostate cancer and dysphagia or difficulty swallowing may benefit from TAVT-45 compared with abiraterone acetate tablets.

TAVT-45 granules for oral suspension (abiraterone acetate) yielded positive topline results and demonstrated therapeutic equivalence to abiraterone tablets (Zytiga) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), according to a press release from Tavanta Therapeutics on data from the phase 3 TAVT45C02 trial (NCT04887506).

The primary end point of the trial was reached, as TAVT-45 and abiraterone tablets yielded comparable serum testosterone levels at days 9 and 10 of treatment vs the tablets. Additionally, the key secondary end point of reducing prostate-specific antigen levels by 50% or more from baseline did not show a statistical difference between the treatment arms. Moreover, the safety profile of TAVT-45 was consistent with those reported when abiraterone tablets were used.

“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 the 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.”

TAVT-45 is an alternative formulation of abiraterone acetate designed for the treatment of metastatic prostate cancer by producing an oral suspension when reconstituted with water or juice. The agent may benefit a population of patients who have dysphagia or difficulty swallowing tablets, potentially increasing the bioavailability of abiraterone and allowing a lower dose to be taken.

Investigators of the global, randomized, multi-center, open-label phase 3 TAVT45C02 trial evaluated the pharmacokinetics, efficacy, and safety of TAVT-45 and abiraterone tablets in combination with prednisone among patients with mCRPC or high-risk mCSPC.

Patients were randomly assigned to either receive 250 mg of TAVT-45 granules for oral suspension twice a day or 500 mg of abiraterone tablets once daily. Patients in both arms also received 5 mg of prednisone once per day if they had mCSPC or twice a day if they had mCRPC.

Patients 18 years and older with a pathologically confirmed diagnosis of adenocarcinoma of the prostate were eligible to enroll on the trial. Additional inclusion criteria included having received ongoing therapy with a gonadotropin releasing hormone agonist or antagonist, having an ECOG performance status of 0 to 2 at screening, normal organ function with acceptable laboratory values, and a life expectancy of at least 6 months at screening.

Patients who initiated bisphosphonate or denosumab therapy 4 weeks prior to beginning treatment were unable to enroll on the study. Patients were also unsuitable for enrollment if they had therapy with estrogen 4 weeks before the start of study treatment, known central nervous system metastases, a history of adrenal gland dysfunction, or a history of other malignancies within the 2 previous years.

“Approximately 20 to 30 percent of [patients with] cancer, 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,” Andreas Maetzel, MD, PhD, chief medical officer at Tavanta Therapeutics, concluded.

Reference

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 9, 2023. bit.ly/3XmeZFL

Recent Videos
A phase 1 trial assessed the use of PSCA-directed CAR T cells in patients with metastatic castration-resistant prostate cancer.
Findings from a phase 1 study may inform future trial designs intended to yield longer responses with PSCA-targeted CAR T cells.
A phase 1 trial assessed the use of PSCA-directed CAR T cells in patients with metastatic castration-resistant prostate cancer.
Two women in genitourinary oncology discuss their experiences with figuring out when to begin a family and how to prioritize both work and children.
Over the past few decades, the prostate cancer space has evolved with increased funding for clinical trial creation and enrollment.
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Anemia in patients who receive talazoparib plus enzalutamide for metastatic castration-resistant prostate cancer appears to be manageable without any compromises in patient-reported outcomes and quality of life.
Related Content