Celsion Announces Progression-Free Survival Data From GEN-1 Phase I Immuno-Oncology Study of Patients with Stage III/IV Ovarian Cancer
Single Arm Study Demonstrated a Median Progression-Free Survival (PFS) of 24.3 Months for Patients Treated per Protocol;
Patients in the Intent-to-Treat Population had a Median PFS of 17.1 months versus Historical Median PFS of 12 Months
All Patients Treated at the Highest Dose Cohort Achieved Complete Surgical Resection After Interval Debulking Surgery
Study Demonstrated That GEN-1 is
“The OVATION I Study results are highly encouraging,” said
In the OVATION I Study, complete tumor resections (R0s) were achieved for all patients receiving the highest dose of GEN-1, and approximately 86% of patients in OVATION I had a complete or partial response. Patients administered GEN-1 and NAC demonstrated meaningfully longer PFS compared to the historical average for chemotherapy alone, with longer PFS observed in the higher dose cohorts. GEN-1 was well tolerated and no dose-limiting toxicities were detected. Intraperitoneal administration of GEN-1 was feasible with broad patient acceptance.
"We are very pleased with the results from the OVATION I trial,” said Dr.
“The observed clinical benefit in the OVATION I Study is not only remarkable, it is supported with convincing translational data. The ability of GEN-1 with NAC to improve survival is now being further evaluated in our recently initiated Phase I/II OVATION 2 Study,” said
About OVATION I Study
The Phase IB OVATION I Study evaluated escalating doses of GEN-1 in combination with three cycles of neoadjuvant chemotherapy prior to interval surgery followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients received escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for eight treatments in total, followed by interval debulking surgery. A total of 18 patients were enrolled to one of four dosing cohorts (Cohort 1: 36 mg/m2; Cohort 2: 47 mg/m2; Cohort 3: 61 mg/m2; Cohort 4: 79 mg/m2). Three patients dropped out of the study after 13 days or less, and two patients did not receive complete GEN-1 plus neoadjuvant chemotherapy treatment.
About OVATION 2 Study
OVATION 2 is a Phase I/II study designed with a single dose-escalation phase to 100 mg/m² of GEN-1 administered intraperitoneally in the Phase I portion, followed by a continuation at the selected dose in Phase II, in an open-label, 1:1 randomized design. In OVATION 2, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy prior to debulking surgery, with continued chemotherapy and GEN-1 dosing following surgery. OVATION 2 will include up to 130 patients with Stage III/IV ovarian cancer, with approximately 12 patients in the Phase I portion and up to 118 patients in Phase II. The study is powered to show a 33% improvement in the primary endpoint, progression-free survival (PFS), when comparing GEN-1 with adjuvant chemotherapy versus adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later. Under the open-label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study's investigators. Data from the dose-escalating portion of OVATION 2 are expected in the first half of 2019.
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
Marianne Lambertson VP Communications & Investor Relations609-482-2498 email@example.com Argot Partners Sam Martin212-600-1902 Sam@argotpartners.com
Source: Celsion CORP