Raoul S. Concepcion, MD, FACS
Nearly a decade ago, sipuleucel-T (Provenge) became the first FDA-approved personalized cancer vaccine, a harbinger of the current era of immunotherapy. After the autologous cellular vaccine gained approval in April 2010, its entry into the clinic was accompanied by expectations that it would see significant uptake by men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Several other trials are testing combinations or sequencing of sipuleucel-T with radiotherapy, checkpoint inhibitors, and other therapies. “It will maintain itself as a go-to medication for metastatic castrate-resistant prostate cancer, but the future is in combination therapy— learning how to mix it not only with chemotherapy, but with androgen-receptor pathway blockers or with other immunotherapeutic agents that might enhance the overall response to sipuleucel- T,” said Leonard G. Gomella, MD, director of the Kimmel Cancer Center Network at Thomas Jefferson University Hospital in Philadelphia.
Impact on PSA
Sipuleucel-T treatment begins with leukapheresis, typically at a physician’s office or blood-collection center. The harvested white blood cells, most importantly dendritic antigen-presenting cells, are sent to a manufacturing facility. They are incubated with a recombinant fusion protein consisting of prostatic acid phosphatase (PAP), an antigen that is highly expressed in most prostate cancer cells, and granulocyte-macrophage colony-stimulating factor.
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