Adding GEN-1 to Standard Chemotherapy Halts Advanced Ovarian Cancer Progression, Phase 1b Trial Shows

Adding GEN-1 to Standard Chemotherapy Halts Advanced Ovarian Cancer Progression, Phase 1b Trial Shows
A combination of Celsion’s DNA-based immunotherapy GEN-1 and standard chemotherapy halted disease progression in women with stage III/IV ovarian cancer eligible for surgery, according to results of a Phase 1b trial. The findings also revealed that all patients on the highest GEN-1 dose had complete tumor removals, and approximately 86% of patients had a complete or partial response, meaning total or partial disappearance of cancer signs. GEN-1 is a nanoparticle including the DNA sequence for the pro-inflammatory molecule interleukin-12 (IL-12). When delivered to the tumor, GEN-1 leads to a sustained production and release of IL-12, inducing an immune response against the tumor cells. The OVATION I study (NCT02480374) in women with new stage III/IV ovarian cancer evaluated increasing doses of weekly GEN-1, for a total of eight doses, combined with three cycles of neoadjuvant chemotherapy — Paraplatin (carboplatin) and Taxol (paclitaxel) — before tumor-debulking surgery, which was followed by three more chemotherapy cycles. GEN-1 doses started at 36 mg/m² and then increased to 47 mg/m², 61 mg/m², and 79 mg/m². Results from the 13 patients who completed treatment showed a median progression-free survival (PFS) — the length of time patients live without cancer progression — of 24.3 months, which was higher in the higher-dose groups. When including the five patients who did not receive the full treatment course, PFS was 17.1 months. “The OVATION I study results are highly encouraging,” Premal H. Thaker, MD
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *