Enrollment in Phase 2 Clinical Trial Evaluating a Novel Vaccine for Treating Triple-Negative Breast Cancer Begins
Enrollment has begun in a pivotal clinical trial evaluating a novel therapeutic vaccine candidate TPIV200 to evaluate the prevention of cancer recurrence in women with triple-negative breast cancer (TNBC) who have completed first-line surgery and radiotherapy/chemotherapy.
TPIV200 is a novel cancer vaccine that has been shown to induce a robust and long-lasting “memory” T-cell immune response directed against folate receptor alpha (FRa), a molecule that is overexpressed on the surface of the vast majority of TNBC cancer cells and is associated with cancer recurrence. TPIV200 appears to stimulate both T “helper” cells and T “killer” cells to target tumor cells.
About the Phase 2 Trial
The Phase 2 trial will enroll 280 women with Stage Ib-IV triple-negative breast cancer who have completed initial surgery and radiotherapy/chemotherapy, prior to any disease recurrence. The two-arm trial is designed to compare vaccination with TPIV200 plus an adjuvant (GM-CSF) with a control group that gets GM-CSF alone. Patients will receive six monthly injections of their assigned treatment regimen for the first six months, followed by booster doses every six months. In addition to safety monitoring, the primary efficacy endpoint is disease-free survival of TPIV200-vaccinated patients compared to that of control patients.
TPIV200 is being evaluated in multiple ongoing Phase 2 trials for treating ovarian and breast cancer, including a randomized dosing trial in TNBC that recently completed patient enrollment. The four-arm trial is designed to help determine the optimal TPIV200 vaccine dose and regimen to maximize patients’ anti-tumor immune responses. Interim immunogenicity results from this ongoing study are anticipated in the first half of 2018.