Celsion says iDMC recommends continuation of Phase III OPTIMA study
Celsion Corporation announced that the independent Data Monitoring Committee has unanimously recommended the OPTIMA Study continue according to protocol. The recommendation was based on a review of blinded safety and data integrity from 556 patients enrolled in the Company's multinational, double-blind, placebo-controlled pivotal Phase III study with ThermoDox plus RFA in patients with hepatocellular carcinoma, or primary liver cancer. The iDMC pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred in August 2019. Data presented demonstrated that PFS and OS data appear to be tracking with patient data observed at a similar point in the Company's subgroup of patients followed prospectively in the earlier Phase III HEAT Study, upon which the OPTIMA Study is based. The data review demonstrated the following: The OPTIMA Study patient demographics and risk factors are consistent with what the Company observed in the HEAT Study subgroup with all data quality metrics meeting expectations. Median PFS for the OPTIMA Study reached 17.3 months as of August 2019. These blinded data compare favorably with 16.8 months median PFS for the 285 patients in the HEAT Study subgroup of patients treated with RFA greater than 45 minutes and followed prospectively for overall survival. At this time point, combined Overall Survival for both treatment arms is consistent with that observed in the 285 patient prospective HEAT Study subgroup. The OPTIMA Study has lost only 4 patients to follow-up from the initiation of the trial in September 2014 through August 2019; the trial design allows for 3% loss per year. The iDMC reviews study data at regular intervals, with the primary responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design.