Celsion Corporation (CLSN)

[Biobonic]

The primary outcome measures is OS

From Clinicaltrials

The Primary endpoint is: Overall Survival (OS) [Time Frame: 5 years]
Overall survival is defined as the time (in months) from the date of randomization to the death date.

A secondary outcome:Progression-free survival (PFS) [Time Frame: 5 years]
Progression-free survival is defined as the time (in months) from the date of randomization until the date of the Investigator-assessed radiological disease progression or death due to any cause.


The talk around this preplanned interim efficacy review was the hazard ratio.

In the Celsion PR of Nov 4, 2019: The OPTIMA Study, like other oncology studies, is subject to tumor progression, and the timing of efficacy results is entirely event driven. We estimate that our next interim safety and efficacy analysis will occur during the second quarter of 2020.”

“The hazard ratio for success at 158 events is 0.70. This is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA > 45 minutes,” Mr. Tardugno added.

Edit: If the hazard ratio at 158 deaths is 0.70 or above, does that trigger the finding that the trial is a success?