Celsion Reports Data Safety Monitoring Board Recommendation to Proceed to Phase II of the OVATION 2 Study in Advanced Ovarian Cancer
Excellent Surgical Response Noted at the Higher, 100 mg/m2 Dose
Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable
Risk/Benefit When Administered Over a Six-Month Period, Up to 17 Doses
The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery (IDS), followed by three additional cycles of chemotherapy in order to treat any remaining tumor after the surgery.
The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1 is a formulation of
- Of the 15 patients treated in the Phase I portion of the OVATION 2 Study:
- Nine were treated with GEN-1 at a dose of 100 mg/m² plus NACT,
- Six were treated with NACT only,
- All 15 had successful resections of their tumors, with seven out of nine patients (78%) in the GEN-1 treatment arm having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and
- Only three out of six patients (50%) in the NACT only treatment arm had an R0 resection.
- When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to the current standard of care NACT:
|% Patients with R0 Resections|
|0, 36, 47 mg/m² of GEN-1 plus NACT||n=12||42%|
|61, 79, 100 mg/m² of GEN-1 plus NACT||n=17||82%|
- The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were comparable, as expected, to the 61, 79, 100 mg/m² higher dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.
The Company also engaged
|GEN-1 Population||PFS Hazard Ratio (Confidence Interval)|
|Intent-to-treat, n=15||0.53 (95% CI 0.16, 1.73); log-rank p=0.29|
|Per-protocol, n=14||0.33 (95% CI 0.08, 1.37); log-rank p=0.11|
Patients in the GEN-1 arm virtually demonstrated a doubling of control of their cancer compared with the SCA. Findings are not statistically significant due to the small number of patients.
“These findings show a consistent dose dependent clinical response in both surgical outcome and tumor response. This is further supported by a series of translational data of the tumor microenvironment,” noted Dr.
“We are excited to be moving into the Phase II portion of the OVATION 2 Study, and thank the
About GEN-1 Immunotherapy
GEN-1, designed using
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Source: Celsion CORP