Dr Myre on a Phase 1 Study of SYNC-T SV-102 in Prostate Cancer

“The safety profile was very favorable [with] 95% grade 1/2 AEs, [the] most common being fever and hematuria. [There were] no grade 4/5 AEs.”

Brian Myre, MD, a medical oncologist at the Center for Thoracic Cancer Care and Center for Genitourinary (GU) Cancer Care at Brian Moran Cancer Institute of Duly Health and Care, discussed findings from a phase 1 trial (NCT05544227) evaluating SYNC-T SV-102 in advanced/​metastatic castration-resistant prostate cancer.

Early findings from the study, which evaluated the locally delivered therapy for patients with advanced disease demonstrated a favorable safety profile and encouraging signs of antitumor activity, Myre began. Although only 15 patients had been treated at the time of the analysis, the preliminary results suggest that this approach may offer an alternative to traditional systemic immunotherapy strategies, he noted.

From a safety standpoint, treatment was generally well tolerated. The vast majority of adverse effects (AEs; 95%) were grade 1 or 2 in severity and manageable, Myre explained. The most frequently reported toxicities were fever and hematuria, both of which are commonly encountered with local therapies affecting the urinary tract, he added. Importantly, no grade 4 or 5 AEs were observed, and no treatment-related toxicities associated with severe or life-threatening complications were reported, he noted.

The safety profile of SYNC-T SV-102 differed from that typically seen with systemic immunotherapies, such as immune checkpoint inhibitors, which are associated with a range of immune-related AEs that can involve multiple organ systems, Myre noted. The predominantly low-grade and localized toxicities observed in this study suggest that SYNC-T SV-102 may provide a more tolerable option for some patients, particularly those who may not be ideal candidates for systemic therapy, he added.

In addition to the favorable tolerability profile, the efficacy results were noteworthy. Among the 15 patients treated, 8 achieved a complete response, representing more than half of the study population, Myre said. These findings suggest that locally delivered therapy may be capable of inducing meaningful and durable responses in patients with advanced disease, he concluded.