abiraterone acetate (TAVT-45) / Tavanta Therap - LARVOL DELTA

Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signalling inhibitors: the role of combination treatment therapy (SGU 2023) - "The addition of ARSIs to ADT in mHSPC tends to increase overall HR-QoL and prolong time to first deterioration of pain/fatigue compared with ADT alone, ADT with first generation nonsteroideal anti-androgens, and ADT with docetaxel. ARSIs show a complex interaction with remaining HR-QoL domains. We advocate a standardization of HR-QoL measurement and reporting to allow further comparisons."

Clinical

Niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: Second interim analysis (IA2) of MAGNITUDE (DGU 2023) - No abstract available.

Clinical

Breaking FDA approval — niraparib-abiraterone for BRCA-mutated #prostatecancer! One hybrid pill, ease of treatment. Congrats to the #MAGNITUDE team @JanssenUSOncMed ! https://onclive.com/view/fda-approves-niraparib-plus-abiraterone-acetate-for-mcrpc @PCFnews @urotoday @ZEROCancer

Radiation plus intensive systemic therapy improves outcomes in prostate cancer subset (Healio) - "Over the past decade, treatment for de novo metastatic prostate cancer has moved toward a 'more is better' approach, with evidence showing doublets of ADT chemotherapy (docetaxel) or novel hormone therapies (abiraterone, enzalutamide [Xtandi; Astellas, Pfizer], apalutamide [Erleada, Janssen] and darolutamide [Nubeqa, Bayer]) with chemotherapy conferring better outcomes than ADT alone. Further studies suggested a triplet of abiraterone and olaparib (Lynparza; AstraZeneca, Merck) perform better than doublets for patients with BRCA alterations."

Online posting

A novel abiraterone acetate oral suspension for patients with metastatic prostate cancer: An open-label, phase 3, randomized trial. (ASCO 2023) - P3 | " Patients with castrate-resistant or castrate-sensitive mPC (mCRPC or mCSPC) were randomized 1:1 to receive TAVT-45 (1 sachet of AA granules [250 mg] in water or juice, twice daily) or R-AA tablets (2 x 500 mg once daily ≥1 h before or ≥2 h after food), plus prednisone (5 mg once [mCSPC] or twice [mCRPC] daily) for 84 days. This Phase 3 study demonstrates that TAVT-45, a novel AA formulation with improved bioavailability, yields similar testosterone/PSA responses and a comparable safety profile to R-AA, and as an oral solution, may be suitable for mPC patients with dysphagia. Clinical trial information: NCT04887506."

Clinical • Metastases • P3 data • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Liquid Biopsy Characterizing CTCs Can Aid in Treatment Selection - "'Hormonal agents prolong the lives of men with castrate-resistant prostate cancer. The optimal sequence of agents to maximize survival is unknown. It is not known if a taxane would be more beneficial after an androgen receptor-directed therapy. We need biomarkers that can be used each time a treatment decision is needed,' explained Howard Scher, MD...."

Media quote

Tavanta Therapeutics to Showcase Specialty Pipeline During the 2023 American Society of Clinical Oncology (ASCO) and American Society of Colon and Rectal Surgeons (ASCRS) Annual Congresses (PRNewswire) - "Tavanta Therapeutics...today announced that it will present new data from its metastatic prostate cancer program during the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago, as well as from its anal fissure program during the upcoming American Society of Colon and Rectal Surgeons (ASCRS) Annual Meeting being held June 3-6 in Seattle....At ASCO, we will present detailed Phase 3 results for TAVT-45 that further demonstrate its potential to become the first FDA-approved oral suspension formulation of abiraterone acetate for patients with metastatic prostate cancer..."

P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Tavanta Therapeutics Announces Positive Top-line Results from Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer (PRNewswire) - P3 | N=107 | NCT04887506 | Sponsor: Tavanta Therapeutics | "Tavanta Therapeutics...announced positive top-line results from its pivotal, global Phase 3 clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate) Granules for Oral Suspension ('TAVT-45')....The primary endpoint comparing serum testosterone levels at Days 9 and 10 was met, demonstrating therapeutic equivalence between TAVT-45 and Zytiga®. The key secondary endpoint (a decrease of ≥ 50% in prostate-specific antigen [PSA] levels from baseline at any time over the 84-day treatment period) showed no statistical difference between treatment arms. The safety profile of TAVT-45 in the trial was in line with that of Zytiga®....Tavanta intends to present detailed results from this Phase 3 registrational study, TAVT45C02, at an upcoming medical meeting, as well as submit for publication."

P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TAVT45C02: TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (clinicaltrials.gov) - P3 | N=107 | Completed | Sponsor: Tavanta Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TAVT45C02: TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (clinicaltrials.gov) - P3 | N=107 | Active, not recruiting | Sponsor: Tavanta Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2022 ➔ Aug 2022

Enrollment closed • Trial primary completion date • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Tavanta Therapeutics Announces Completion of Enrollment in Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer (PRNewswire) - "Tavanta Therapeutics...announced the completion of patient enrollment in the Company's pivotal Phase 3 study for TAVT-45 (abiraterone acetate) Granules for Oral Suspension ('TAVT-45'). TAVT45CO2 is a global Phase 3 clinical trial evaluating TAVT-45 in patients with metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC). The primary objective of the study is to establish therapeutic equivalence between TAVT-45 and Zytiga tablets....Topline Results Expected in Q4 2022; Company Plans to Submit a New Drug Application (NDA) to the U.S. Food & Drug Administration in Q3 2023."

Enrollment closed • NDA • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

TAVT45C02: TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Tavanta Therapeutics | Trial completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose Finding and Food Effect Studies of a Novel Abiraterone Acetate Formulation for Oral Suspension in Comparison to a Reference Formulation in Healthy Male Subjects. (PubMed, Pharmaceutics) - "This novel TOS formulation also addresses some of the limitations of current AA treatment, including low bioavailability, high variability in systemic exposure and a large food effect. It may offer an alternative for patients with dysphagia or discomfort with swallowing large pills."

Clinical • Journal • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 3 study to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer (clinicaltrialsregister.eu) - P3; N=108; Ongoing; Sponsor: Tavanta Therapeutics, Inc.

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MRI

Tavanta Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of TAVT-45 (abiraterone acetate) Granules for Oral Suspension, a Novel Formulation of Abiraterone Acetate, for the Treatment of Metastatic Prostate Cancer (PRNewswire) - "Tavanta Therapeutics...announced that the first patient has been dosed in a recently initiated global Phase 3 clinical trial evaluating TAVT-45 (abiraterone acetate) Granules for oral suspension (TAVT-45 granules), a novel and proprietary formulation of abiraterone acetate. In agreement with the U.S. Food and Drug Administration (FDA), the safety and efficacy of TAVT-45 Granules is being studied in a single Phase 3 trial as a treatment for metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC)....The trial, which aims to recruit a total of 108 patients, is expected to complete enrollment within the second quarter of 2022."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (clinicaltrials.gov) - P3; N=108; Recruiting; Sponsor: Tavanta Therapeutics

Clinical • New P3 trial • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ASCO GU 2021: Recommendations From Dr. Oliver Sartor (PracticeUpdate) - "Dr. Oliver Sartor...recommends the following presentations at the upcoming ASCO Genitourinary Cancers Symposium, which will take place virtually on February 11 through February 13, 2021....Molecular determinants associated with long-term response to apalutamide (APA) in nonmetastatic castration-resistant prostate cancer (nmCRPC)...Genomic landscape of advanced prostate cancer in racial minority populations: Real-world experience in a safety-net hospital oncology clinic."

Online posting

Plasma gene conversions after one cycle (C) abiraterone acetate (AA) for metastatic castration-resistant prostate cancer (mCRPC): A biomarker analysis of a multi-centre, international trial (MAP 2019) - "These findings suggest that tracking gene aberrations in plasma DNA could be an early marker of treatment efficacy."

Biomarker • Clinical

DRGT announces first subject dosed in a phase I clinical trial of DRGT 45, a novel formulation of abiraterone acetate for prostate cancer (GlobeNewswire, Druggability Technologies Holdings Ltd) - "Druggability Technologies Holdings (DRGT) today announces the first subject dosed in a two-part Phase I trial to evaluate the pharmacokinetics, safety, and oral bioavailability of DRGT-45 (abiraterone acetate tablets for oral suspension) to treat prostate cancer. DRGT-45 (abiraterone acetate), is a second-generation prostate cancer therapy therapy that inhibits the production of testosterone, which is implicated in the growth of prostate cancer, through blockade of CYP17."

Enrollment open

Comprehensive genetic profiling unravels molecular targets in prostate cancer (LWW Journals) - "'Although these new drugs, such as abiraterone, enzalutamide, and apalutamide, are approved for different phases of advanced prostate cancer, disease progression on these drugs is literally universal,' said Neeraj Agarwal...'This is the largest-ever report of prostate cancer tumors tested by CGP,' Agarwal told..."

Media quote

In clinical practice in the United States, half of mCRPC patients have not received treatment aiming to extend survival [ASCO GU 2019] [Google translation] - "In the treatment, the novel hormone therapeutic agents avilaterone and enzaltamide were used most frequently, and it was also shown that the continuous administration of these two agents was more frequent. Celestia S. Higano of University of Washington announced at the Genitourinary Cancers Symposium..."

Media quote