Celsion Announces Highly Encouraging Initial Clinical Results from the Phase I Portion of the Phase I/II OVATION 2 Study with GEN-1 in Patients with Advanced Ovarian Cancer
R0 (Complete) Surgical Resection Rates for Patients Randomized to GEN-1 Treatment Arm Compare Favorably to Patients Receiving Neoadjuvant Chemotherapy Only
Company to Proceed with Phase II Portion of the OVATION 2 Study After All Phase I Patients Have Completed Their Full Treatment Regimen (up to 17 doses of GEN-1)
GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below:
- Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT and six patients were treated with NACT only. All 15 patients had successful resections of their tumors, with seven out of nine patients (78%) in the GEN-1 treatment arm having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had a 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:
|% of Patients with|
|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 higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.
As previously reported, the independent Data Safety Monitoring Board (DSMB) for the OVATION 2 Study completed its initial safety review of data from the first 15 patients treated with the first four weekly doses of GEN-1 at 100 mg/m², and confirmed that there were no apparent dose-limiting toxicities in any of the six evaluable patients (those patients who received at least four weekly doses of GEN-1) and that intraperitoneal administration of GEN-1 is well tolerated even when given with standard NACT.
The OVATION 2 Study is an open-label, 130-patient, 1-to-1 randomized Phase I/II trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1 is a formulation of
The OVATION 2 Study builds on encouraging clinical and translational research data from the Phase Ib OVATION 1 Study, in which enrolled patients received escalating weekly doses of GEN-1 up to 79 mg/m² for a total of eight treatments in combination with NACT, followed by IDS. These data from the OVATION 1 Study were presented at the ASCO-SITC Clinical-Oncology Symposium by Dr.
“Of the nine patients treated with GEN-1 at 100 mg/m² plus NACT in the Phase I portion of the OVATION 2 Study, seven patients had an R0 resection at the time of their interval debulking surgery. A recent article published in the
1219 (2017) 100-105
“These data provide an early, but highly encouraging trend in both Phase I studies, and even more so when the study populations are combined to provide a larger ‘n’,” stated
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
|Celsion Investor Contact||LHA Investor Relations|
|Executive Vice President, CFO and Corporate Secretary||Senior Vice President|
Source: Celsion CORP