Celsion’s OVATION 1 Study with GEN-1 in Ovarian Cancer Shows Strong Progression-Free Survival Treatment Effect Utilizing Medidata Synthetic Control Arm
Synthetic Randomization Provides Means to Evaluate Strategies to
GEN-1’s strong and encouraging treatment effect, evidenced by the synthetic control arm, suggests a potentially remarkable improvement in PFS, an FDA recognized surrogate for Overall Survival, and appears to confirm the science behind IL-12’s ability to recruit the innate and adaptive elements of the immune system to fight malignancies. The strong PFS trend is supported with previously published translational data that clearly demonstrates the pro-immune changes in the tumor micro-environment associated with loco-regional GEN-1 therapy.
Celsion’s current randomized Phase II OVATION 2 Study in advanced ovarian cancer patients will commence in the 2nd half of 2020 and is designed to demonstrate a 33% improvement in PFS (HR=0.75) over current standard of care. PFS is the primary endpoint for this study.
Synthetic Control Arms have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where a randomized control is not ethical or practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the patients treated with the new investigational product.
SCAs have been shown to mimic the results of traditional randomized controls so that the treatment effects of an investigational product can be visible by comparison to the SCA. SCAs can help advance the scientific validity of single arm trials, and in certain indications, reduce time and cost, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them.
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PFS data generated from this analysis comparing GEN-1 with SCA showed the following:
|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|
“The patients in the GEN-1 arm of the OVATION I Study virtually demonstrated a doubling of control of their cancer than the Synthetic Control Arm. Although these findings are not statistically significant due to the small numbers, they are impressive nonetheless,” said Dr.
The Phase Ib OVATION I Study evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NACT) prior to interval debulking surgery, followed by three cycles of NACT in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer. Previously reported data demonstrated median PFS of 21 months in the per-protocol population and 17.1 months in the intent-to-treat population for all dose cohorts, comparing favorably to historically reported median PFS of 12 months.
In the OVATION I Study, complete tumor resections (R0s) were achieved for all patients receiving the highest (79 mg/m2) dose of GEN-1, and approximately 86% of patients in OVATION I had a complete or partial response. All patients experienced a clinically significant decrease in their CA-125 protein levels as of their latest study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. 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 extremely impressed with the high quality of the matched data from the Medidata SCA,” said
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About Celsion Corporation
|Celsion Investor Contact||LHA Investor Relations|
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Source: Celsion CORP