BRIDGEWATER, N.J., /PRNewswire/ -- Valeant Pharmaceuticals North America LLC (VPNA) today announced that preliminary findings from the ongoing Phase 4 PROCEED (PROVENGE® Registry for the Observation, Collection, and Evaluation of Experience Data) registry suggest that in the real-world setting, palliative radiation therapy prior to sipuleucel-T (PROVENGE®) for advanced prostate cancer does not inhibit successful production of sipuleucel-T.
The goals of the PROCEED registry are to further evaluate the safety and efficacy of sipuleucel-T in a real-world setting and expand on findings from the IMPACT trial, the pivotal Phase 3 study which resulted in FDA
approval of sipuleucel-T for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. In IMPACT, patients who received radiation treatment less than 28 days prior to registration were excluded due to potential immunosuppression and reduced ability to manufacture sipuleucel-T.
In the PROCEED registry, prior treatments, such as chemotherapy or radiation therapy, did not have an exclusionary period prior to sipuleucel-T administration. PROCEED data show the percentage of patients who received prior palliative radiation therapy and all three sipuleucel-T infusions did not differ from the percentage who did not receive prior palliative radiation therapy and all three infusions (93.2% versus 95.0%; p=0.707) suggesting palliative radiation for bone metastases does not inhibit successful sipuleucel-T production.
Speaking at the annual American College of Radiation Oncology (ACRO) meeting, Dr. Steven Finkelstein, M.D., a Board-certified radiation oncologist who was one of the PROCEED registry's principle investigators, said, "This exciting work highlights radiation therapy's effect on in-vivo immunity. It is clear that large-scale immune monitoring studies will be needed to fully ascertain optimal approaches to stimulate patient's immunity against cancer."
"These data are interesting and add to published data suggesting prior therapies, thought to be immunosuppressive, do not preclude subsequent use of sipuleucel-T," said Jim Caggiano, general manager of Dendreon for Valeant Pharmaceuticals International, Inc., the company that manufactures PROVENGE (sipuleucel-T).
Important Safety Information for PROVENGE
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. Before getting PROVENGE, tell your doctor if you:
What are the possible side effects of PROVENGE?
PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems.
Develop numbness or weakness on one side of the body, decreased vision in one eye or difficulty speaking. Any of these may be signs of a stroke.
Develop symptoms of thrombosis which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath or chest pain that worsens on deep breathing.
Get a fever over 100°F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection.
The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.