Tuesday, May 4, 2021
Immunotherapy GEN-1Given Fast Track Approval
The drug, GEN-1, is a non-viral particle that stimulates the production of interleukin-12 to the tumor site. This protein stimulates the immune system to target the tumor.
The trial successfully completed Phase 1 (Ovation-1) which combined standard chemo with GEN-1 in newly diagnosed women prior to surgery. That study showed that women had a partial or complete reduction in tumor burden compared with women who received the lowest doses. In addition, 88% of these women had complete surgical resection - meaning that they had clean margins, free of any microscopic evidence of cancer. Those women who received both GEN-1 and chemo lived twice as long as those who only received chemo. Because the sample size was too small, the results were not clinically significant.