Therapy Areas: Oncology
Dendreon Offers New Clinical Data Analysis On Survival Benefit Three Years after Treatment with Sipuleucel-T
20 February 2019 - - US-based commercial-stage biopharmaceutical company Dendreon Pharmaceuticals LLC has 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), the company said.

The analysis which interpreted survival outcomes using number needed to treat to benefit 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.

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.

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 that, at one year, the NNTB value 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.

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 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.

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.

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.

Provenge is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy.

The company'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 US 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.
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