Largest Real-World Study of Immunotherapy Shows Men with Advanced Prostate Cancer with Low PSA had a Median Survival of Nearly Four Years after Treatment with PROVENGE® (sipuleucel-T)

– Data from Nearly 2,000 Patients Finds that Men Treated with PROVENGE when Baseline PSA was <5.27 ng/mL Lived 47.7 Months –

– Findings Consistent with Pivotal IMPACT Trial –

SEAL BEACH, CA, USA I Septemer 04, 2019 I Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, today announced publication of results from its PROCEED registry, which evaluated real-world use of PROVENGE® (sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). The findings, published in Cancer1, showed that men with mCRPC who were treated with PROVENGE when their PSA was <5.27 ng/mL had a median survival of nearly four years.

“Median baseline PSA levels at mCRPC diagnosis have declined steadily since the approval of PROVENGE in 2010”

“The median survival of four years following treatment with PROVENGE is meaningful,” said Celestia S. Higano, M.D., FACP, lead author of the PROCEED analysis, and professor, Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center. “PROCEED provides a real-world portrait of the expected OS after sipuleucel-T in mCRPC patients in the modern era of five additional life-prolonging agents.”

Notably, 44% of patients with a PSA of <5.27 ng/mL did not receive any additional cancer treatments for at least one year. Of those, 95% were treated with PROVENGE as first-line therapy for mCRPC as recommended by the National Comprehensive Cancer Network (NCCN).

“Median baseline PSA levels at mCRPC diagnosis have declined steadily since the approval of PROVENGE in 2010,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “Of the nearly 2,000 patients enrolled in PROCEED between 2011-2014 a quarter had a PSA of <5.27 ng/mL, and these men lived much longer than those in the higher quartiles. It’s worth noting that the median baseline PSA levels observed in PROCEED are lower than those in the pivotal IMPACT trial and would likely be lower if PROCEED was enrolling today.”

PROCEED Registry – Baseline PSA and Median Survival

  • <5.27 ng/mL – 47.7 months
  • >5.27 to ≤15.08 ng/mL – 33.2 months
  • >15.08 to ≤ 46 ng/mL – 27.2 months
  • >46 ng/mL – 18.4 months

Findings from the PROCEED registry are consistent with a previous post-hoc analysis of the pivotal Phase 3 IMPACT trial of sipuleucel-T published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with improved overall survival (OS). Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months (3.4 years) for those treated with sipuleucel-T vs. 28.3 months for those in the control arm – an improvement of 13 months.2

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings. Patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL.

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.

For full Prescribing Information, please visit www.dendreon.com/Products.

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.

1Higano CS, Armstrong AJ, Sartor AO, et al. Real‐world outcomes of sipuleucel‐T treatment in PROCEED, a prospective registry of men with metastatic castration‐resistant prostate cancer. Cancer 2019 LINK

2 Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013;Jun;81(6):1297-1302.

SOURCE: Dendreon

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