Overview of Prostate Cancer
Prostate cancer is the second leading cause of cancer in men, and the fifth leading cause of cancer deaths.1
Current Treatments and Unmet Needs
Abiraterone acetate is the most-prescribed second-generation anti-androgen for men with metastatic prostate cancer and generates over 250,000 prescriptions annually in the United States. The initial formulation, Zytiga® (abiraterone acetate) is indicated for the treatment of metastatic castration-resistant prostate cancer and high-risk metastatic castration-sensitive prostate cancer, in combination with prednisone.2 However, there are several limitations of available abiraterone formulations, including large tablet size, requirement to take on an empty stomach, and high variability in systemic exposure that could result in suboptimal clinical outcomes.3,4
TAVT-45 is a novel oral suspension of abiraterone acetate. It was designed as an alternative abiraterone acetate formulation with clear benefits over branded Zytiga tablets.
TAVT-45 granules are rapidly reconstituted in water or juice and easily consumed, which could aid the ~20-30% of patients who have dysphagia or difficulty swallowing.5,6 In clinical studies with TAVT-45, variability in abiraterone exposure was reduced compared to Zytiga, and bioavailability was enhanced in subjects in a fasted state. The improved absorption profile allows for a reduction in the total daily dose of TAVT-45 compared to Zytiga and may potentially improve exposure to therapeutic abiraterone concentrations over 24 h. The large food effect of Zytiga is also avoided, and we anticipate TAVT-45 to be dosed without regard to meals.
The pivotal Phase 3 trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga in patients with metastatic castrate-resistant prostate cancer and metastatic high-risk castrate-sensitive prostate cancer, in addition to demonstrating a comparable safety profile.7 The NDA is under preparation. Tavanta is currently evaluating strategic options for this asset, an easy-to-swallow alternative to Zytiga, intended for patients with metastatic prostate cancer who have difficulty swallowing.
1 NIH – National Cancer Institute, Surveillance, Epidemiology and End Results Program – https://seer.cancer.gov/statfacts/html/prost.html
2 ZYTIGA® (abiraterone acetate) tablets – Prescribing Information: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ZYTIGA-pi.pdf
3 Carton E, Noe G, Huillard O, et al. Relation between plasma trough concentration of abiraterone and prostate-specific antigen response in metastatic castration-resistant prostate cancer patients. Eur J Cancer. 2017;72:54-61.
4 van Nuland M, Groenland SL, Bergman AM, et al. Exposure-response analyses of abiraterone and its metabolites in real-world patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020;23(2):244-251.
5 Frowen J, Hughes R, Skeat J. The prevalence of patient-reported dysphagia and oral complications in cancer patients. Support Care Cancer. 2020 Mar;28(3):1141-1150.
6 Drumond N, Stegemann S. Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience. Pharmaceutics. 2020 Dec 28;13(1):32.