Sillajen said that it believes that the Independent Data Monitoring Committee (DMC)’s suspension recommendation for its phase 3 clinical trial for Pexa-Vec in treating liver cancer was additional data that spawned from salvation therapies.
Salvation therapy refers to the use of other medicines that a physician considers when there is no first-line treatment response in clinical practice.
Sillajen said it has recently confirmed such facts through an interim analysis, while also confirming that the number of patients who received additional drugs was higher in the control group than the experimental group.
According to primary data sent from the U.S. contract research organization, 63 of the 203 patients who received Pexa-Vec and Nexavar in the experimental group underwent a salvation treatment, while 76 out of the 190 patient who received Nexavar alone in the control group received other drugs.
“The company has confirmed that a total of five anti-cancer treatments – Opdivo, Cyramza, Lenvima, Stivarga, and Cabometyx -- were used as a salvation therapy,” the company said. “While Opdivo, Cyramza, and Lenvima were administered in about the same number in both groups, Stivarga and Cabometyx were administered much more in the control group.”
Kwon Hyuk-chan, head of Sillajen’s clinical trial, said, “We believe that the use of salvation therapies in phase 3 clinical trial had a major impact on the results. Therefore, we do not believe that Pexa-Vec is not effective.”
Although further analyses are required, the company speculates that the futility results may have been different if both groups received additional doses at a similar rate, Kwon added.