Longer survival seen in men with androgen independent prostate cancer.


ANAHEIM, Calif.—Men with androgen independent prostate cancer (AIPC) who have received initial treatment with sipuleucel-T (Provenge) followed by docetaxel after progression of their disease may have prolonged survival, according to new findings presented here at the American Urological Association annual meeting.

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Researchers caution, however, that the optimal timing and sequence of sipuleucel-T in conjunction with chemotherapy will still need to be determined in future trials.


Sipuleucel-T is the first in a new class of active cellular immunotherapies (ACIs) uniquely designed to stimulate a patient’s own immune system. This autologous active cellular immunotherapy is in late-stage clinical development for the treatment of men with early stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period.


Researchers analyzed survival data from 82 men with asymptomatic, metastatic AIPC who participated in two Phase III clinical trials of sipuleucel-T. These men initially received treatment with either sipuleucel-T or placebo. They subsequently received docetaxel after progression of their disease.


Men who received initial treatment with sipuleucel-T followed by docetaxel had a median survival of 34.5 months compared with 25.4 months for those men in the placebo arm who received treatment with docetaxel, a 9.1-month difference. Men in the sipuleucel-T arm had a 47% reduction in their risk of death compared with those in the placebo arm.


“The results of this analysis suggest that the use of sipuleucel-T as a first-line treatment followed by the chemotherapy docetaxel upon disease progression may provide patients with a substantially prolonged survival benefit,” said lead author Daniel Petrylak, MD, associate professor of medicine at Columbia University Medical Center in New York.


“This analysis provides valuable clinical insight as to how the treatment of men with advanced prostate cancer will likely evolve with the potential introduction of new products like sipuleucel-T that complement the currently available treatment regimens for men with advanced prostate cancer.”


Dr. Petrylak noted that the agent has a good safety profile. “The major side effects you see with this are chills, fevers and things you would see with any type of immunological treatment that is being given,” he said.


A FDA advisory committee recently supported the safety and effectiveness for the use of sipuleucel-T in men with metastatic AIPC.