Press Release: Dendreon Initiates Large-Scale Clinical Trial to Investigate PROVENGE (sipuleucel-T) in Men with Early-Stage Prostate Cancer on Active Surveillance
ProVent Trial Aims to Halt Disease Progression, Reduce Need for Aggressive Intervention
SEAL BEACH, Calif.--(BUSINESS WIRE)-- Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, today announced it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of PROVENGE® (sipuleucel-T) in reducing disease progression in men with prostate cancer on active surveillance (AS). PROVENGE was the first U.S. Food and Drug Administration (FDA)-approved immunotherapy made from a patient's own immune cells and remains the only immunotherapy treatment for prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
"Dendreon led the way with PROVENGE, the first active cellular immunotherapy approved by the FDA," said Jim Caggiano, chief executive officer of Dendreon. "We have already established that PROVENGE helps mCRPC patients live longer, and physicians have prescribed it to over 30,000 men. With this trial, Dendreon is taking another leadership position in the treatment of prostate cancer; if successful, it could again revolutionize the way the disease is treated."
Nearly 165,000 men are diagnosed with prostate cancer every year.1 Approximately 30 to 40 percent opt for AS2 - which includes regular monitoring to ensure the cancer is not growing or spreading - instead of choosing more aggressive treatment options. AS can allow men to delay - or even avoid - surgery and radiation, which often result in life-altering side effects.3 To date, no anti-cancer drug has been proven to prevent the disease from progressing during AS.
"The large body of data collected on PROVENGE has proven it has a significant impact on increasing overall survival in men with mCRPC," said Bruce A. Brown, M.D., senior vice president, medical, at Dendreon. "With the ProVent trial, our aim is to determine if PROVENGE can reduce prostate cancer disease progression in men on AS and potentially provide an alternative to choosing a treatment that can negatively impact quality of life."3
The ProVent clinical trial will assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS, with a targeted enrollment of 450 participants. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization are eligible to enroll. Study enrollment is expected to begin in late 2018, with topline results expected in 2023.
About the ProVent Trial
The randomized, double-blind, placebo-controlled, multicenter ProVent trial will be conducted at approximately 50 sites across the United States. Study participants will be randomized 2:1 to receive PROVENGE or placebo. The primary objective of the trial is to assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS.
The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher. Secondary endpoints include the number of study participants with subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate the association of immunologic responses with efficacy and patient quality of life outcomes.
About Active Surveillance (AS)
During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every 1-2 years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer, while retaining the option of definitive therapy.
AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology and National Comprehensive Cancer Network.
About PROVENGE® (sipuleucel-T)
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.
Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.
Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.
Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.
Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.
Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
For full Prescribing Information, please visit https://www.provengehcp.com/.
About Dendreon
Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy. Dendreon's flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient's own immune cells. More than 30,000 men with advanced prostate cancer have been prescribed PROVENGE in the U.S. since 2010. Dendreon also is evaluating the use of PROVENGE in early-stage prostate cancer, with the hope of curing more men of the disease. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit www.dendreon.com.
1 American Cancer Society. Key Statistics for Prostate Cancer. LINK
2 Johns Hopkins Medicine. Men with Low-Risk Prostate Cancer in Active Surveillance Program Not Likely to Succumb to the Disease, Study Shows. LINK
3 Chen RC, JAMA. (2017) 317(11):1141-1150. Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer. LINK
4 Klotz L., J Clin Oncol (2015) 33:272-277. LINK
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Leslie Bryant
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