Genitope’s immunotherapy fails endpoint in Phase III lymphoma trial

In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax personalized immunotherapy compared to patients receiving the control substance. Importantly, analysis of a pre-specified endpoint in the MyVax personalized immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.

In this pivotal, double-blind, randomized, controlled clinical trial, patients first received chemotherapy to reduce their tumor burden, followed by a 6-month rest period. Patients who maintained at least a partial response through the rest period were then randomized to the MyVax personalized immunotherapy or control arm in a 2:1 ratio. Patients who received MyVax personalized immunotherapy received a patient- and tumor-specific idiotype protein conjugated to a foreign carrier protein called keyhole-limpet hemocyanin (KLH). Patients in the control arm received a non-specific immunotherapy consisting only of KLH. Patients in both arms received granulocyte macrophage-colony stimulating factor (GM-CSF) as an immunologic adjuvant at each immunization.

Dan Denney, Jr., chairman and CEO of Genitope, said: “We are excited by these results because the data clearly show that MyVax personalized immunotherapy is a safe and active drug for follicular lymphoma patients. While we recognize that the regulatory path would be clearer had the trial met its primary endpoint, we are pleased with the outcome of the trial.”