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Meta-Analysis of Atrasentan Studies in Prostate Cancer Suggest Delay in Time to Disease Progression

New Orleans, Louisiana, June 5, 2004 — An analysis examining pooled data from two clinical studies of atrasentan shows a statistically significant (p=0.013) delay in time to disease progression in men with metastatic, hormone refractory prostate cancer who took the drug versus those who took placebo. Analyzed separately these studies trended toward atrasentan, but did not show statistical significance.

The data were presented today by Michael A. Carducci, M.D., Johns Hopkins Kimmel Cancer Center at the American Society of Clinical Oncology (ASCO) annual meeting.

Atrasentan is an oral, non-hormonal, non-chemotherapy investigational anti-cancer agent. Prostate cancer is the most common solid tumor in American men. An estimated 230,000 men will be diagnosed with prostate cancer and 29,000 will die from the disease this year in the United States.

"These meta-analysis results are encouraging and show that atrasentan holds promise for the treatment of metastatic, hormone-refractory prostate cancer," said Perry Nisen, M.D. Ph.D., divisional vice president, Global Oncology Development at Abbott Laboratories.

Meta-Analysis of M96-594 & M00-211
To examine the overall treatment effect of atrasentan in men with metastatic, hormone refractory prostate cancer, Abbott conducted a simple retrospective pooling of its two large, randomized, well-controlled clinical trials (M96-594 & M00-211) with a total patient population of 1097. Results pooled from two different atrasentan doses (2.5mg and 10mg) demonstrate a statistically significant (p=0.013) delay in time to disease progression in the intent to treat analysis for men taking atrasentan vs. placebo.

The two individual studies pooled for the meta-analysis tested the same patient population with similar baseline demographics, used the same endpoint of time to disease progression (radiographic progression was more explicitly defined in the M00-211 protocol) and were placebo-controlled and double blind. Abbott has conducted statistical tests for heterogeneity of the studies and on the overall treatment effect to support the rigor of the meta-analysis.

Atrasentan (10mg) was generally well tolerated in both studies among all patients. The most common associated adverse events for atrasentan vs. placebo were, headache (21 percent vs. 13 percent), peripheral edema (39 percent vs. 13 percent), and rhinitis (34 vs. 14 percent) respectively.

"A meta-analysis is a useful tool in assessing modest but nevertheless clinically important treatment effects. The combined results from these studies are very encouragning and suggest atrasentan may be an exciting novel treatment option which targets the endothelin axis," said Professor David Dearnaley, MD, FRCP, Institute of Cancer Research/Royal Marsden Hospital. "These are the first trials to explore the benefit of the endothelin-A receptor antagonists in hormone refractory prostate cancer and give rise to optimism than an entirely different class of agents may be valuable after failure of conventional treatments."

About Atrasentan
Atrasentan, an oral, once-daily, non-hormonal, non-chemotherapy, anti-cancer agent, belongs to a class of compounds known as selective endothelin-A receptor antagonists, or SERAs. SERAs antagonize the effect of endothelin (ET-1), one of the proteins thought to be involved in the stimulation of the spread of cancer cells. Atrasentan is the result of Abbott's discovery effort in oncology.

Atrasentan has been studied in Phase II and Phase III clinical trials in patients with metastatic, hormone refractory prostate cancer. It is currently in its second Phase III pivotal trial (M00-244) involving men with prostate cancer that has not spread (non-metastatic). It is also being evaluated in a Phase II trial (M01-366) in men with rising prostate-specific antigen (PSA) following prostate cancer surgery. Additionally, Abbott continues to support the investigation of atrasentan in other cancers including kidney, ovarian, brain, and non-small-cell lung cancers.

Atrasentan has been granted fast track review status from the U.S. Food and Drug Administration (FDA).

Source: Abbott Laboratories

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