Pexa-Vec data off due to other drugs, maker saysData from trials of the Pexa-Vec liver cancer therapy may have been thrown off by “salvage treatments,” the developer of the drug has argued as an independent committee calls for an end to the testing.
Salvage treatments are utilized when a patient fails to respond to standard treatments and other efforts are undertaken. The alternatives used can render data from studies less useful.
SillaJen, the maker of the therapy, said in a statement Tuesday that 35 percent of Phase 3 clinical trial patients were being cared for with salvage treatments.
The company said the number and proportion of patients who received additional drugs were higher in the control group that solely received cancer inhibitor Nexavar than in the experimental group, which received Pexa-Vec and Nexavar together.
A total of 63 patients out of 203 patients injected with Pexa-Vec and Nexavar were also injected with other drugs for salvage treatment, while 76 patients out of 190 patients injected solely with Nexavar for comparison were treated the same way.
Those opting for salvage treatments received five liver cancer therapies all approved by the U.S. Food and Drug Administration after 2017, SillaJen added.
“We believe that the use of salvation treatments in the Phase 3 clinical trial had a big impact on the results, so we do not believe that Pexa-Vec was ineffective,” said Kwon Hyuk-chan, head of clinical trial at SillaJen.
“Although other analyses are needed moving forward, if both groups received salvation treatments in similar proportions, there is a chance that the futility results would be different.”
BY KO JUN-TAE [firstname.lastname@example.org]