Dr Appleman on Prior Data With SYNC-T Therapy SV-102 in Prostate Cancer

“[LEGION-100] is a large study that is open at multiple sites that will look at the efficacy and safety of SYNC-T Therapy SV-102.”

Leonard J. Appleman, MD, PhD, the director of the Genitourinary Cancer Disease Section, the section chief of genitourinary medical oncology, and an associate professor of medicine at the University of Pittsburgh Medical Center, discussed data with SYNC-T Therapy SV-102 in metastatic prostate cancer that were reported in a phase 1 trial (NCT05544227) and the ongoing phase 2 LEGION-100 study (NCT06533644).

The phase 1 study enrolled 15 patients, all of whom had previously received androgen deprivation therapy; 20% had also been treated with prior chemotherapy, representing a heavily pretreated patient population, Appleman began. The overall response rate with SYNC-T Therapy SV-102 was 87%, with 53% (95% CI, 29%-79%) achieving a complete response, he continued.

In terms of safety, SYNC-T Therapy SV-102 was well tolerated with relatively few high-grade adverse effects (AEs) reported, Appleman said. The most common treatment-related AEs included fever and hematuria, both of which were manageable, he noted. Immune-related AEs were uncommon, although isolated cases of grade 2 hypothyroidism and grade 2 hepatitis were observed, he said.

Building on these encouraging results, the multicenter LEGION-100 is evaluating SYNC-T Therapy SV-102 in patients with metastatic castration-resistant prostate cancer. The study will follow a similar design to the phase 1 trial, Appleman noted. Eligible patients are required to have experienced disease progression following treatment with at least 1 FDA-approved second-generation androgen receptor pathway inhibitor with or without a prior course of taxane therapy, have an ECOG performance status of 0 or 1, have at least 1 measurable lesion per RECIST 1.1 criteria, and have a life expectancy of at least 6 months. The primary end points are safety, ORR, and determining the recommended phase 2, maximum tolerated, and optimal biologic dose levels.