Dendreon Completes Enrollment of Phase 3 ProVent Clinical Trial Evaluating Sipuleucel-T in Men on Active Surveillance

October 30, 2019 Off By BusinessWire

Dendreon has completed enrollment of of 450 patients, in Phase 3 ProVent clinical trial testing Sipuleucel-T in men on active surveillance, with topline results expected in 2023.

SEAL BEACH, Calif.–(BUSINESS WIRE)–#activesurveillance–Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, announced early completion of patient enrollment of its Phase 3 ProVent clinical trial. More than 450 subjects were randomized in the large-scale clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE^®) in reducing disease progression in men with early-stage prostate cancer on active surveillance (AS).

“The rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on AS,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “PROVENGE has been proven to extend life in men with mCRPC, and we intend to change the way prostate cancer is treated by showing that immunotherapy can reduce disease progression and the need for aggressive intervention in men with early-stage disease.”

Nearly 175,000 men are diagnosed with prostate cancer every year.¹ Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS, which includes regular monitoring to assess whether the cancer is progressing, instead of more aggressive treatment options such as surgery or radiation.^2,3

“For men with low-risk, localized prostate cancer, the option of AS is regularly recommended; however, variation in PSA monitoring and the anxiety of having a ‘cancer’ diagnosis causes many men to leave surveillance management and undergo interventional treatment,” said Neal D. Shore, M.D., FACS, ProVent principal investigator, medical director for the Carolina Urologic Research Center and a practicing urologist at Atlantic Urology Clinics in Myrtle Beach, S.C. “Both patients and physicians have desired a proactive therapy for appropriate AS patients in order to optimize their long-term outcomes. Given the numerous studies describing the effectiveness of sipuleucel-T immunotherapy for advanced prostate cancer, we are optimistic that data from ProVent may lead to the first-ever immunotherapy treatment option for men with early-stage prostate cancer.”

About the ProVent Trial

The randomized, multicenter Phase 3 ProVent trial is assessing the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization were eligible to enroll in the study, which is being conducted at approximately 60 sites across the United States. Study participants were randomized 2:1 to receive sipuleucel-T or remain 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 at 33-39 months after randomization. Secondary endpoints include the number of study participants who receive subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate quality of life and the association of immunologic responses with efficacy.

Enrollment in the ProVent study began in late 2018, and topline results are expected in 2023.

For more information, visit www.ProVentStudy.com or clinicaltrials.gov (NCT03686683).

About Active Surveillance (AS)

During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every one to two 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 the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

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.

Click here for full Prescribing Information.

About Dendreon

Dendreon is a commercial-stage biopharmaceutical company and is the only company in the U.S. with an FDA-approved active cellular immunotherapy for a solid tumor. 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. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed October 16, 2019.

² Johns Hopkins Medicine. Men with low-risk prostate cancer in active surveillance program not likely to succumb to the disease study shows. https://www.hopkinsmedicine.org/news/media/releases/men_with_low_risk_prostate_cancer_in_active_surveillance_program_not_likely_to_succumb_to_the_disease_study_shows. Accessed October 16, 2019.

³ Chen RC, Basak R, Meyer AM, et al. 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. JAMA. 2017;317(11):1141-1150. https://www.ncbi.nlm.nih.gov/pubmed/28324092.

⁴ Klotz L, Vesprini D, Sethukavalan P, et al. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015; 33:272-277. https://ascopubs.org/doi/full/10.1200/jco.2014.55.1192.