– Prospective, Real-World Data Analysis Showed Additional Overall Survival Benefit with PROVENGE in African-American Patients –

– Results Presented in Oral Session at AUA 2017 –

– Prostate Cancer Disproportionately Affects African-American Men, Who Have Twice the Mortality Rate of Caucasian Men –

May 13, 2017 11:20 AM Eastern Daylight Time

SEAL BEACH, Calif.–(BUSINESS WIRE)–Dendreon today announced findings from a new analysis of its PROCEED registry, which followed men with metastatic castrate-resistant (hormone-refractory) prostate cancer (mCRPC) treated with PROVENGE® (sipuleucel-T) in a real-world treatment setting. The analysis found that African-American patients demonstrated an additional median OS benefit of 9.3 months compared with Caucasian patients (37.3 months vs 28.0 months, respectively).i Among the group of patients below the median prostate specific antigen (PSA) levels at the time of PROVENGE treatment, African-American patients demonstrated an additional OS benefit of nearly two additional years (20.9 months) compared with Caucasian patients (54.3 months vs. 33.4 months, respectively).i

“These new findings are very encouraging given that African-American men with prostate cancer have a mortality rate more than twice as high as Caucasian men and historically have presented with aggressive disease and have had worse outcomes in both real-world settings and controlled clinical trials”

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These compelling results were presented today in an oral podium presentation at the 112th American Urological Association (AUA) Annual Meeting in Boston by lead author A. Oliver Sartor, M.D., the Laborde Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine. PROVENGE is the first and only U.S. Food and Drug Administration (FDA)-approved autologous cellular immunotherapy on the market.

“These new findings are very encouraging given that African-American men with prostate cancer have a mortality rate more than twice as high as Caucasian men and historically have presented with aggressive disease and have had worse outcomes in both real-world settings and controlled clinical trials,” said Dr. Sartor. “The fact that we saw an even greater benefit in African-American patients within the lower PSA quartile ranges is also important and provides further evidence that PROVENGE should be used as early as possible within its labeled indication.”

The PROCEED registry enrolled more than 1,900 patients with mCRPC who received PROVENGE between 2011 and 2013 in everyday treatment settings.Of these, approximately 12 percent were African-American.i The analysis presented at the AUA meeting compared OS in a subset of African-American patients (n=210) and Caucasian patients (n=420) matched by baseline PSA.i

The analysis showed that the median OS was significantly greater in the African-American patients than in the Caucasian patients (37.3 months vs 28 months, p<0.001).African-American patients also had better outcomes than Caucasian patients when OS was assessed based on the median PSA level (26.8 ng/mL) and by PSA quartiles.i Among those with a PSA level below the median, the OS was 54.3 months for African-American patients vs. 33.4 months for Caucasian patients – a difference of 20.9 months (p<0.001).A multivariate analysis found that African-American race was an independent baseline predictor of improved OS (p<0.001) following treatment with PROVENGE.

The findings from the PROCEED analysis regarding the full population are consistent with an analysis of the Phase 3 IMPACT registration trial of PROVENGE published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with a greater overall survival benefit with PROVENGE. Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months for those treated with PROVENGE vs. 28.3 months for those in the control arm – an improvement of 13 months.ii

“These new PROCEED registry data suggest that patients with asymptomatic or minimally symptomatic mCRPC may benefit the most with early use of PROVENGE and provide a rationale for immunotherapy as an early treatment strategy in sequencing algorithms for mCRPC,” said James Caggiano, president of Dendreon. “We are pleased to be able to provide this new clinical data about how metastatic prostate cancer patients respond to and benefit from PROVENGE in everyday clinical practice. It should be useful to urologists and oncologists in supporting treatment decisions for their patients, especially their African-American patients, who typically are more likely to be diagnosed with advanced disease and to have higher mortality.”

About Prostate Cancer in African-American Men

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths.iii

Prostate cancer is also the most commonly diagnosed cancer in African-American men, representing 31 percent of all cancers.iv It is estimated that in 2016, one in six African-American men were diagnosed with prostate cancer – an estimated 29,530 new cases – and one in 23 had a lifetime probability of dying from their disease.v The incidence of prostate cancer is 60 percent higher among African-American than Caucasian men,and the mortality rate is more than twice as high,vi which prostate cancer incidence patterns from population modeling suggest is likely due to a higher incidence of preclinical disease and higher risk of progression to metastatic disease before clinical diagnosis among African-American men compared with the general population.vii Based on this modeling, African-American men are more likely to be diagnosed with prostate cancer at a younger age and a higher stage and to have their disease progress after treatment compared with Caucasian men.vi The lifetime probability of an African-American man dying of prostate cancer is almost double that of a Caucasian man (4.4 percent vs. 2.4 percent).iv

About PROVENGE® (sipuleucel-T)

PROVENGE® (sipuleucel-T) 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 http://www.dendreon.com/Products.

About Dendreon

Dendreon is a healthcare company whose mission is to transform lives through the discovery, development, commercialization and manufacturing of novel personalized immune-therapeutics for cancer. Dendreon manufactures PROVENGE® (sipuleucel-T), which was approved by the U.S. Food and Drug Administration in April 2010. Dendreon is exploring the application of additional product candidates for the potential treatment of a variety of cancers. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit http://www.dendreon.com.

i Sartor O, et al. Overall Survival Analysis of African American and Caucasian Patients Receiving Sipuleucel-T: Preliminary Data from the PROCEED Registry. Presented at the 2017 American Urological Association (AUA) Annual Meeting; May 13, 2017; Boston, Mass.
ii Schellhammer PF, et al. 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):1297-302.
iii Jemal A, et al. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225–249.
iv American Cancer Society. Cancer Facts & Figures for African Americans. https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html. Accessed April 2017.
v American Cancer Society. Cancer Facts & Figures for African Americans 2016-2018. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2016-2018.pdf. Accessed April 2017.
vi Sultan DH, et al. Affecting African American men’s prostate cancer screening decision-making through a mobile tablet-mediated intervention. J Health Care Poor Underserved. 2014;25(3):1262–1277. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160127/. Accessed April 2017.
vii Tsodikov A, et al. Is prostate cancer different in black men? Answers from 3 natural history models. Cancer. April 242017. DOI: 10.1002/cncr.30687.

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Contacts for Dendreon
Media Contact:
Melanie Weiss, 212-257-6995
mweiss@w2ogroup.com

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