FCS Among First in Florida to Trial Next-Generation Immunotherapy for Castration-Resistant Prostate Cancer

Statewide Practice Enrolling Patients in Global, Late-Phase Clinical Trial

Fort Myers, Fla., January 22, 2025 —  Florida Cancer Specialists & Research Institute, LLC (FCS) is among the first oncology providers in Florida selected to enroll patients in a phase 3 clinical study of pasritamig, a new cancer therapy called a bispecific T‑cell engager, being developed by Johnson & Johnson for prostate cancer that has spread beyond the prostate and no longer responds to hormone therapy.

“This trial represents an exciting step forward in next-generation immunotherapy research for prostate cancer,” said Bradley Monk, MD, FCS medical director of late-phase clinical research, who leads initiatives across the statewide practice to monitor and evaluate the effectiveness of new drugs and therapies that are transforming cancer treatment worldwide.

Prostate cancer is the most commonly diagnosed malignancy worldwide and the sixth leading cause of cancer-related death in men. When confined to the prostate, the disease is considered localized and potentially curable. If the disease has spread outside the prostate, many cancers become resistant to available therapies.

FCS is among a select group of 172 locations globally participating in the trial that will evaluate the overall survival of patients given pasritamig in combination with best supportive care (BSC) as compared to placebo with BSC. Dr. Monk noted that this is FCS’ first enrollment to a late phase bispecific T-cell engager clinical trial. FCS offers step-up dosing and maintenance therapy with FDA-approved bispecific drugs to treat recurring and resistant blood cancers and small cell lung cancer.

“Treatment-resistant cancers pose a major challenge in medicine,” said Elizabeth Guancial, MD, FCS medical oncologist and hematologist who is serving as principal investigator. “I’m proud that FCS is helping lead this research—giving patients new hope and opportunities to participate in cutting-edge care, especially since the early phase data to support it was generated in our very own DDU. We believe this example of seamless drug development directly benefits our patients by providing faster access to next wave therapies.”

Pasritamig brings a patient’s T‑cells directly to prostate cancer cells by binding both the cancer cell protein KLK2 and the T‑cell receptor CD3, allowing the T‑cells to attack and kill the cancer. To learn  more about the new phase 3 trial: https://clinicaltrials.gov/study/NCT07164443

FCS provides ongoing access to more than 180 clinical trials within 29 FCS clinics statewide and early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. In recent years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation.

For a complete list of FCS clinical trials: https://www.clinicaltrialnavigator.com/