Tuesday, May 4, 2021

Immunotherapy GEN-1Given Fast Track Approval

The FDA announced approval to fast track a novel immunotherapy treatment for advanced ovarian cancer.

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.

To find out more about this Phase 1/2 study, you can follow this link that will take you to the Clinical Trials page. To read the article about this study, follow this link.

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