New Clinical Data Analysis Shows Survival Benefit Three Years after Treatment with Sipuleucel-T

Data Presented at 2019 ASCO Genitourinary Cancers Symposium Underscore
Even Greater Survival Benefit in African-American Men Treated with
Immunotherapy

SEAL BEACH, Calif.–(BUSINESS WIRE)–Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical
company and pioneer in the development of immunotherapy, released
results of a new retrospective analysis of clinical trial data showing a
long-lasting survival benefit three years after treatment with PROVENGE® (sipuleucel-T)
in men with metastatic castrate-resistant prostate cancer (mCRPC). (abstract
#222)

The analysis – which interpreted survival outcomes using number needed
to treat to benefit (NNTB) – showed a favorable survival benefit for all
men treated with sipuleucel-T compared to placebo, and a significantly
greater survival benefit in African-American men over a three-year time
period.

“African-American men see a much greater survival advantage with
sipuleucel-T based on the findings of this analysis, which is critically
important given these men tend to present with more aggressive disease
and have greater than twice the mortality rate than that of Caucasian
men,”1 said Kelvin A. Moses, M.D., Ph.D., lead author of the
analysis and associate professor in the Department of Urology at
Vanderbilt University Medical Center. “These data underscore the
survival benefit resulting from treatment with sipuleucel-T in all men
and may help address the known survival disparity in African-American
men with prostate cancer.”

The analysis pooled data from three placebo-controlled Phase 3 trials of
sipuleucel-T involving 737 men with mCRPC and calculated the NNTB
benefit at 12, 24 and 36 months for all patients treated with
sipuleucel-T (n=488) and a cohort of African-American men (n=33). NNTB
is the number of patients needed to be treated with a therapy to prevent
one additional death at a given time compared to placebo. The lower the
NNTB the more effective a treatment is. Results showed:

  • At one year, the NNTB value (13) was the same for the pooled patients
    and the African-American cohort, showing that 13 men treated with
    PROVENGE prevented one additional death compared to placebo.
  • At two years, NNTB values were 10 for the pooled patients and 5 for
    the African-American cohort.
  • At three years, NNTB values were 8 for the pooled patients and 3 for
    the African-American cohort.

“This analysis reinforces earlier findings that sipuleucel-T provides an
overall survival benefit to both African-American and Caucasian mCRPC
patients,” said Bruce A. Brown, M.D., chief medical officer at Dendreon.
“The enhanced survival outcomes in African-American men should serve as
a call to action for urologists and oncologists to recommend
immunotherapy to all African-American patients that stand to benefit
from treatment.”

Additional findings presented in poster sessions at the 2019 ASCO GU
Cancers Symposium include two analyses of data from Dendreon’s PROCEED
registry:

  • Experience with sipuleucel-T in mCRPC with visceral spread from
    PROCEED

    (abstract #174)

    A registry
    analysis of patients treated with PROVENGE in patients with visceral
    metastases, including of the liver and lung, found that, as expected
    and consistent with the literature for other treatments, these men had
    shorter median overall survival (OS) than men without visceral
    metastases (20.5 months vs. 31.2 months). The analysis also found that
    activation of antigen-presenting cells, a measure of immune activation
    and treatment potency, was similar in those with and without visceral
    metastases. These findings suggest that men with mCRPC and visceral
    spread of their disease can activate their immune cells to produce
    PROVENGE.

  • Real-world registry data from PROCEED: sipuleucel-T in elderly men
    with mCRPC (abstract #177)

    A second analysis found that
    PROVENGE was generally well tolerated among an elderly cohort of 374
    patients age 80 years and older. All grade and grade 3-5 serious
    adverse events were comparable between the elderly cohort and men
    younger than age 80 (n=1,528). PROVENGE was generally well-tolerated
    and may be considered a first-line option for elderly men with
    asymptomatic or minimally symptomatic mCRPC.

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 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 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. Cancer Facts and Figures for
African American Men. Accessed 07Feb19. LINK

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