Big news in the oncology world, the FDA has approved PROVENGE, the first autologous cellular immunotherapy for patients with prostate cancer. The new therapy is meant for patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is “castrate-resistant,” or “hormone-resistant,” which means that these patients have not responded to standard anti-hormone treatment that prostate cancer patients receive.
The therapy works by collecting antigen-presenting cells from the patient in a procedure called leukapheresis. The cells are subsequently exposed to prostatic acid phosphatase, a protein that is commonly present in high concentrations in prostate cancer cells. These primed antigen presenting cells are then infused back into the patient. Once in the patient’s body these antigen presenting cells, theoretically, instruct the immune system to attack and destroy the cancer cells. Multiple double-blind randomized placebo controlled clinical trials have shown significant mortality benefits with the therapy when compared with placebo.
Here is more from the press release:
Three Phase 3 studies involving 737 patients were submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, double blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic CRPC. PROVENGE extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared to the control group (25.8 months versus 21.7 months). Overall, PROVENGE reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
"The approval of PROVENGE represents a significant advancement in the care of men with advanced prostate cancer. PROVENGE offers a new choice in the front line treatment for these men who – until today – had few appealing treatment options," said David Penson, M.D., Professor of Urologic Surgery at Vanderbilt University Medical Center…
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence ≥ 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The success of this therapy is truly a remarkable accomplishment and may signal the beginning of a trend long predicted of personalized cancer treatments that will hopefully be more efficacious and have fewer side effects.
Read the press release here…
Learn more at the PROVENGE website
Phase 3 trials: Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer.; Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer.