Genitope Corporation said data from its pivotal phase III clinical trial, examining the use of MyVax personalised immunotherapy (MyVax) in previously untreated follicular B-cell non-Hodgkin's lymphoma (fNHL) patients, did not meet its primary endpoint.
In December 2007, Genitope obtained data indicating that its pivotal Phase 3 clinical trial failed to meet the primary end points. The primary analysis demonstrated that there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax compared to patients receiving a non-specific control immunotherapy. However, analysis of a pre-specified endpoint in the group of patients receiving MyVax showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumour-specific target and those who did not.
"We are extremely disappointed in the FDA's decision and deeply saddened that Genitope is unlikely to be able to make MyVax personalised immunotherapy available to fNHL patients in the US," said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer, Genitope Corporation.
In early March 2008, Genitope met with the US Food and Drug Administration (FDA) to discuss a potential regulatory path forward for MyVax. The FDA communicated to Genitope during this meeting that, in light of the phase III clinical trial's failure to meet its primary endpoint, one or more additional phase III clinical trials for MyVax would be required before the FDA would accept a Biologics License Application for FDA review. In light of the FDA's decision, Genitope suspended the development of MyVax in March 2008.