April 14, 2008 Pfizer Anti-CTLA4 antibody trial for melanoma stopped for futility.
"The Data Safety Monitoring Board halted the Phase III randomized open label trial comparing the Pfizer anti-CTLA4 antibody, tremelimumab, to "standard" (and generally ineffective) chemotherapy for metastatic melanoma. The Board has reported that there is no statistical difference between the primary endpoint, overall survival, between the two study arms. Further, statistical analysis reportedly shows that further examination is "futile" or basically unlikely to ever show a statistical difference.
This is a major setback for the hopes of many investigators and patients who felt that the anti-CTLA4 antibodies represent an encouraging potential new therapy for metastatic melanoma, a disease for which there is no universally accepted or generally effective therapy.
Will this completely halt all efforts by Pfizer to develop this drug in melanoma?"
Authored by:
Eric Whitman, MD, is a Medical Director of the Office of Grants and Research for Atlantic Health System in Morristown, New Jersey
The A3671009 Phase III trial in 630 advanced melanoma patients was investigating tremelimumab compared to standard chemotherapy, consisting of dacarbazine and Schering-Plough's Temodar (temozolomide).
I for one, Believe it works but it must be in combination with Interluekin-2. See the Phase III trial was a administered as a single agent.
With my first hand experience, I did one cycle of CTLA-4 therapy and then switched to Interluekin-2. Base on the immune system pathway, the CTLA-4 blockage only activated one signal by attaching to the B7 receptor. It is all in the Medical literature. To get the Immune system to respond, it needs second signal (cell to cell). That is done with IL-2. It is my belief, that there must be time in between therapies to set the pathway and the microenvironment in motion.
I hope Pfizer doesn't give up on this therapy.
Jimmy B
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