Manish R. Patel, MD is Oral Presenter of Abstract Analyzing Effectiveness of First-In-Human Study of Cutting-Edge Treatment For Advanced Prostate Cancer at AUA meeting

Fort Myers, Fla., April 28, 2025—Florida Cancer Specialists & Research Institute, LLC (FCS) Director of Drug Development Manish Patel, MD, was the oral presenter of an abstract analyzing the results of the first in-human study of a first-in-class treatment for patients with metastatic castration-resistant prostate cancer. The abstract, “A Dual Androgen Receptor Ligand-Directed Degrader and Antagonist, for Heavily Pretreated Patients with Metastatic Castration-resistant Prostate Cancer: Results from Additional Exploratory Analyses,” was presented at the annual American Urology Association meeting.

The abstract details updated results from the first-in-human, multicenter study of BMS-986365, a new type of orally-administered drug that degrades and inhibits the Androgen Receptor. Data reported are from the Part B dose expansion at 400, 600 or 900 mg BID (n=20 each) among 68 patients.

The authors concluded, “….Treatment with BMS-986365 was well tolerated, with a manageable safety profile and promising anti-tumor activity. These data show the potential of BMS-986365 to overcome resistance to current ARPI (Androgen Receptor Pathway Inhibitors) in a large segment of patients regardless of AR genomic status.” Additional analyses on clinical benefits is underway.

“These insights equate to good news as we continue our work to improve survival rates for patients with advanced prostate cancer,” said Dr. Patel.

FCS provides ongoing access to more than 150 clinical trials within 29 FCS clinics and three early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida overseen by Dr. Patel. In recent years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation, prior to approval, and many of these therapies began as Phase 1 or first-in-human clinical trials at FCS DDUs.

Lucio N. Gordan, MD, FCS president & managing physician, said, “Through our extensive and expanding clinical trials program, we are helping lead global efforts to save lives by delivering truly personalized treatment options tailored to each patient’s unique condition and genetic makeup.”

To view the abstract in Journal of Oncology:
https://www.auajournals.org/doi/10.1097/01.JU.0001109880.25183.6b.01