Dendreon Pharmaceuticals Partners with Grant Hill to Help Men Start Strong with Advanced Prostate Cancer

– Basketball Legend Raises Awareness of Racial Disparities Within Prostate Cancer Incidence in African American Men –

Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, has partnered with Grant Hill, seven-time NBA All-Star and sports broadcaster, to launch Start Strong, a new initiative to help individuals make decisions with health in mind. Start Strong aims to empower the prostate cancer community to learn about the racial disparities within prostate cancer incidence in the United States and encourage patients to talk to their physicians about the best treatments for them.

“Prostate cancer is a risk for all men, but it disproportionately impacts African American men. In fact, African American men are twice as likely to be diagnosed with and two and a half times more likely to die from prostate cancer than Caucasian men,” said Hill. “When I learned about this disparity, I felt compelled to help educate African American men about the burden of prostate cancer and the potential treatments that can help them manage it. During the upcoming holiday season, many of us will be safely reconnecting with family, and I encourage you to take time to speak with your loved ones about their health. Every second counts when it comes to your health, so it’s crucial that men develop a treatment game plan with their doctor.”

Raising awareness of this disparity is critical as one in seven African American men will be diagnosed with prostate cancer in their lifetime.¹ Further, African American men tend to be diagnosed at a younger age and more severe prognosis compared to other men.² In addition to encouraging African American men to advocate for their health, the Start Strong campaign also aims to educate about the real-world evidence suggesting African American men may live longer than Caucasian men when treated with an immunotherapy called PROVENGE^® (sipuleucel-T).³

In IMPACT, the pivotal, double-blind, placebo-controlled trial that supported FDA approval of PROVENGE, median overall survival (OS) was greater in men who received PROVENGE. Men with metastatic castration-resistant prostate cancer (mCRPC) were randomly assigned to receive PROVENGE or not receive PROVENGE. In men treated with PROVENGE, median OS was 25.8 months compared to 21.7 months in the control group.⁴

Dendreon’s PROCEED is the largest real-world registry to evaluate the safety and secondarily, the survival profile of PROVENGE in nearly 2,000 men with metastatic castrate resistant prostate cancer (mCRPC).^5a In the study, in men with lower baseline prostate specific antigen (PSA) below the median, the median overall survival for African American men was 20.9 months longer than for PSA-matched Caucasian men.^3a,b Other PROCEED findings were consistent with a post hoc analysis of the Phase 3 pivotal IMPACT trial, which suggests that men who start PROVENGE when their PSA level is lower may live longer.^4c

“Not only is prostate cancer one of the most commonly diagnosed cancers in African American men, evidence also suggests they tend to have more advanced disease when it’s found,” said Dr. Vincent Michael Bivins, president of Urology Centers of Alabama. “However, African American men treated with an immunotherapy called PROVENGE may have longer overall survival compared with Caucasian men. That’s why it’s so important to talk to your doctor about all of your treatment options to ensure they’re making the best decision for you.”

For more information, visit startstrong.us to learn about appropriate treatment options for advanced prostate cancer.

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, of whom 1,902 received PROVENGE between 2011 and 2014 in everyday treatment settings. Of these, approximately 12% were African American. In the entire PROCEED population, 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. The sub-analysis published in PCAN compared OS in a subset of African American patients (n=219) and Caucasian patients (n=438) matched by baseline PSA.

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. In 2020, an estimated 191,930 new cases of prostate cancer will be diagnosed in the United States and 33,330 men will die from the disease.¹

African American men have the highest prostate cancer incidence rate of any racial or ethnic group in the world.⁶ In the United States, the risk of prostate cancer is 74% higher in black men than non-Hispanic white men.⁷ The incidence of prostate cancer is about 60% higher in blacks than in whites for reasons that remain unclear.¹ Prostate cancer death rates in blacks are more than double those of every other racial and ethnic group in the United States.¹

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^® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.

IMPORTANT SAFETY INFORMATION

Before receiving PROVENGE^®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.

Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.

The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.

PROVENGE is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, activated, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.

PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:

• Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
• Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
• Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, shortness of breath, chest pain that worsens or deep breathing
• Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites

Tell your doctor about any side effect(s) that concerns you or does not go away. For more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information.

About Dendreon

Dendreon is a commercial-stage biopharmaceutical company and end-to-end provider of manufacturing services for the cell therapy market. Dendreon’s flagship product, PROVENGE^® (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient’s own immune cells and has been prescribed to over 40,000 men with advanced prostate cancer in the U.S. since 2010. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit www.dendreon.com.

References

1. American Cancer Society. Cancer Facts & Figures for African Americans 2019-2021. Accessed June 6, 2021. https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html

2. Centers for Disease Control and Prevention. Prostate Cancer. Accessed June 6, 2021. https://www.cdc.gov/cancer/prostate/basic_info/risk_factors.htm

3. Sartor O, Armstrong AJ, Ahaghotu C, et al. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis. 2020;23(3):517-526. doi:10.1038/s41391-020-0213-7

4. Kantoff PW, Higano CS, Shore ND, et al; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5):411-422. doi:10.1056/NEJMoa1001294

5. Higano 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;125(23):4172-4180. doi:10.1002/cncr.32445

6. JNCI: Journal of the National Cancer Institute, Volume 89, Issue 3, 5 February 1997, Pages 188–189. Accessed 27Nov18. https://academic.oup.com/jnci/article/89/3/188/2526672

7. Cancer.net/ASCO. Prostate Cancer Statistics. Accessed 22Jan19 https://www.cancer.net/cancer-types/prostate-cancer/statistics

^a Baseline PSA levels were significantly different between African American men and Caucasian men. Thus, Caucasians were matched (2:1) to African Americans with baseline PSA levels within ± 10% of the Caucasian baseline PSA value, to minimize the effect of this clinical imbalance on survival.

^bThis subgroup analysis of the PROCEED registry was exploratory and results need careful interpretation.

^c This post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.

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