Celsion Announces Latest Translational Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients
Translational research data was reviewed with leading immuno-oncology experts from the
Key translational research findings from the first 12 of 15 patients¹ enrolled in four patient cohorts are summarized below:
- The treatment-related changes in immune activating cytokines and pro-tumor VEGF and IFN- γ levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients' systemic circulation. The observed immunological changes are consistent with an IL-12 based mechanism.
- Effects observed in the IHC analysis were pronounced decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment.
- The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.
"These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the tumor microenvironment in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamic in the tumor microenvironment," said Dr.
The Company previously announced the latest clinical findings from the OVATION Study in a poster presentation at the
- Of the fourteen patients treated to date, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate (DCR) and an 86% objective response rate (ORR).
- Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.
- Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a margin-negative resection in which no gross or microscopic tumor remains in the tumor bed.
- Of the five patients treated at the highest dose cohort, all five patients (100%) experienced a R0 surgical resection. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection.
- Of the seven patients who have received GEN-1 treatment over one year ago and are being followed, only one patient's cancer has progressed after 11.7 months. This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery². Of the remaining six patients who have been on the study for over one year, their average PFS is 16.4 months with the longest progression-free patient at over 22 months.
"The impressive early trends in tumor response, surgical resections and progression-free survival are consistent with the dose dependent increases in IFN- γ levels, decreases in VEGF levels and immune system activity observed in the translational data," said
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¹ Tissue samples are being collected and translational data from the final three patients will be available in late
² Wright AA, Bohlke K, Armstrong DK, et al: Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer:
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