FOR IMMEDIATE RELEASE: May 31, 2010
Wendy Isett, AUA
SIPULEUCEL-T DEMONSTRATES WELL-TOLERATED SAFETY PROFILE ACROSS RANDOMIZED, PLACEBO-CONTROLLED TRIALS
San Francisco, May 31, 2010–Sipuleucel-T (Provenge), an immunotherapy for men with asymptomatic or minimally symptomatic metastatic, castrate resistant (hormone refractory) prostate cancer, showed a favorable safety profile for androgen dependent prostate cancer (ADPC) and metastatic castrate-resistant prostate cancer (mCRPC), according to new data being presented at the 105th Annual Scientific Meeting of the American Urological Association (AUA). These safety data from integrated analyses will be presented to the media during a special press conference on Monday, May 31, 2010 at 11 a.m.
Data from sipuleucel-T Phase 3 clinical trials for the treatment of mCRPC showed that sipuleucel-T extended median survival and for the treatment of ADPC sipuleucel-T demonstrated an increase in prostate-specific antigen (PSA) doubling time. The data presented today represent an integrated analysis of the safety profile of Provenge across these four Phase 3 clinical trials. The safety population included 904 patients randomized to receive three intravenous doses of sipuleucel-T or placebo at two-week intervals. Of this group, 83.4 percent had an Eastern Cooperative Oncology Group (ECOG) score of O, meaning that they were fully active and able to perform pre-disease activities without restrictions.
Compared to placebo, sipuleucel-T produced only minor or moderate adverse effects, including chills, fever and headache. These reactions occurred less than one day after infusion and resolved within two days. Grade 3 acute infusion reactions (AIRs) occurred in only 3.5 percent of patients and no grade 4 or 5 AIRs were reported. Cerebrovascular events occurred in 3.5 percent of patients in the treatment arm, compared to 2.6 percent of those receiving placebo. AIRs were treated with intravenous H1 and H2 blockers, intravenous meperidine and/or acetaminophen.
Sipuleucel-T is an autologous cellular immunotherapy designed to use live human cells to boost a patient’s immune system to elicit a long-lasting response against cancer. It is the first therapy of its kind for prostate cancer, and recently received U.S. Food and Drug Administration approval for use.
“Most cancers are able to evade the immune system. We have been trying to find ways to stimulate the immune system to control or cure cancer for decades,” explained E. David Crawford, MD, who moderated the press conference. “The prostate is a non-essential organ except for the need for fertility, and it has some very specific antigens or markers such as PSA, PSMA, and prostatic acid phosphatase (PAP), which can be the target of immune therapy strategies. Provenge represents the first successful and FDA approved method to achieve this goal.”
NOTE TO REPORTERS: Experts are available to discuss these studies outside normal briefing times. To arrange an interview with an expert, please contact the AUA Communications Office at the number above or e-mail Communications@AUAnet.org.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 16,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients.