Non-Hodgkin’s Lymphoma Drug Misses Primary Endpoint
Tuesday, January 15, 2008
Genitope reported negative results from a phase III trial of MyVax, a patient-specific immunotherapy, for the treatment of previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL). The subjects enrolled in this double-blind, randomized, controlled clinical trial first received chemotherapy to reduce their tumor burden, followed by a six-month rest period.
Subjects 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. Subjects who received MyVax personalized immunotherapy received a patient and tumor-specific idiotype protein conjugated to a foreign carrier protein called keyhole- limpet hemocyanin (KLH). Subjects in the control arm received a non-specific immunotherapy consisting only of KLH.
Subjects in both arms received granulocyte macrophage-colony stimulating factor (GMCSF) as an immunologic adjuvant at each immunization. Although treatment was determined to be safe and well tolerated, the trial did not meet its primary endpoint. In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of subjects receiving MyVax compared to the control arm.
Analysis of a pre-specified endpoint in the MyVax arm showed a highly statistically significant difference in PFS between subjects who mounted a positive immune response to the tumor-specific target and those who did not.
Based on the results, Genitope plans to meet with the U.S. Food and Drug Administration (FDA) to determine the path forward for MyVax personalized immunotherapy. The FDA granted the drug Fast Track status in 2006.