Syncromune reports 80% two-year survival in a 15-patient Phase 1 trial of SYNC-T Therapy SV-102 for metastatic prostate cancer, with durable complete responses.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Syncromune reported updated long-term survival data from its Phase 1 study of investigational SYNC-T Therapy SV-102 in patients with metastatic prostate cancer. Presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid on October 23 (abstract 2247P), the findings showed that 80% of participants were alive at 24 months. Median overall survival had not been reached at a median follow-up of 29.6 months.
At the April 1, 2026, data cutoff, 12 of 15 patients were alive. Of the six patients who achieved a complete response, three remained disease-free, with follow-up ranging from 26.5 to 35.3 months. Previously reported results included an objective response rate of 87% and a complete response rate of 40%.
These findings provide additional evidence of potentially durable antitumour activity. However, the study’s small population and single-arm design prevent conclusions about whether the treatment improves survival compared with established therapies.
Survival Outcomes by Disease Subgroup
The open-label, single-arm Phase 1 study (NCT05544227) enrolled 15 patients: 10 with metastatic castration-resistant prostate cancer (mCRPC) and five with metastatic hormone-sensitive prostate cancer (mHSPC) who had refused androgen deprivation therapy. Patients received up to 12 treatment cycles at four-week intervals, with each cycle targeting a single tumour lesion.
In the overall population, median overall survival was not reached (95% confidence interval [CI], 27.9 months to not reached), and the 24-month survival rate was 80%.
Among patients with mCRPC, median overall survival was 27.9 months (95% CI, 17.1 months to not reached), with a 24-month survival rate of 70%. In the five-patient mHSPC subgroup, no deaths had occurred by the data cutoff, and the 24-month survival rate was 100%.
The unreached median overall survival indicates that the estimated survival curve had not crossed the 50% threshold at the analysis. The subgroup results should nevertheless be interpreted cautiously because of the small patient numbers and absence of a control group.
Treatment Mechanism and Safety
SYNC-T Therapy SV-102 is an investigational in situ immunotherapy combining a proprietary needle-based device with a locally administered formulation. The device partially freezes and thaws a portion of a selected tumour, disrupting cancer cells and releasing tumour antigens. The formulation, SV-102, is then infused directly into the treated lesion over five minutes.
SV-102 contains four immune-modulating agents: abazistobart (anti-PD-1), futermestotug (anti-CTLA-4), ciltistotug (CD40 agonist) and sitmutolimod (Toll-like receptor 9 agonist). The approach is designed to coordinate tumour antigens and immune-modulating agents in the tumour microenvironment and tumour-draining lymph nodes, with the aim of stimulating a systemic antitumour response.
The company reported that 95% of treatment-emergent adverse events were Grade 1 or 2. No Grade 4 or 5 adverse events or Grade 3 or 4 immune-related toxicities were reported. Although these findings provide an initial indication of tolerability, a 15-patient study cannot establish the treatment’s safety profile in a larger population.
The company also reported regression of distant metastases that had not been directly treated in some patients. This observation warrants further investigation but does not establish that the therapy consistently produces a systemic antitumour effect.
Phase 2a Development
Syncromune is also evaluating SYNC-T Therapy SV-102 in the multicentre Phase 2a LEGION-100 trial (NCT06533644) in patients with mCRPC. According to the company, the study is enrolling at 24 cancer centres across the United States, with international sites expected to open.
The trial is designed to assess safety, tolerability and efficacy while evaluating dosing to support subsequent development. Its results will help determine whether the preliminary clinical activity observed in Phase 1 can be reproduced in a larger study.
SYNC-T Therapy SV-102 remains investigational and has not been approved by any regulatory authority. The current findings do not establish a survival benefit or demonstrate that the treatment can cure metastatic prostate cancer. Further clinical evaluation is needed to determine its potential role in treatment.
References
Syncromune, Inc. Syncromune Reports Long-Term Data from Phase 1 Study in Metastatic Prostate Cancer with Investigational SYNC-T Therapy SV-102. October 27, 2026
Phase 1 Trial of SYNC-T – Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer, ClinicalTrials.gov ID NCT05544227
A Study of SYNC-T Therapy SV-102 in Participants with Metastatic Castration-Resistant Prostate Cancer, ClinicalTrials.gov ID NCT06533644
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.