Back to top

Dendreon Gets Positive IMPACT

Read MoreHide Full Article

Positive IMPACT trial results will likely lead to Provenge approval by the FDA in 1H10

This morning, Dendreon Corporation ([url=]DNDN[/url]) announced results of the long-awaited pivotal phase III IMPACT study of Provenge in men with advanced prostate cancer.

In the news release and the conference call, management disclosed that the phase III study met its primary endpoint of improving overall survival compared to a placebo. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of Provenge appeared to be consistent with prior trials.

As a reminder, Dendreon’s lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine. Previous two phase III studies D9901 and D9902A generated mixed results.

Despite the mixed results, DNDN submitted a biologics license application (BLA) for Provenge in November 2006. The FDA Advisory Committee voted 17 to 0 in favor of the safety of Provenge in response to the question and 13 to 4 in favor of the efficacy question in March 2007. However, the FDA granted Provenge an approvable opinion requesting additional clinical data (IMPACT) in support of the efficacy claim contained in the BLA.

IMPACT is a multi-center, randomized, double-blind, placebo-controlled study which enrolled 512 patients with metastatic androgen-independent prostate cancer, the trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The interim analysis conducted in October 2008 did not achieve a statistical significance, but was very close to the 22% reduction in the risk of death based on 304 events, which led to the final analysis of the IMPACT study.

Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28. The positive IMPACT results confirmed findings of prolonging prostate cancer patient survival in previous phase III studies.

Dendreon intends to file an amendment to its existing BLA in the fourth quarter of this year. We believe the FDA will approve Provenge in early 2010 based on the IMPACT results. We also expect the company will announce a partner for Provenge in Europe soon. Once approved, Provenge may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.

Provenge has blockbuster potential if it is approved for marketing. We estimate US sales will be $120 million in 2010, and $200 million in 2011. We further estimate the company will be profitable in 2010 with an EPS of $ 0.36. With sales potential over $1 billion, Provenge will provide both top line and bottom line growth for Dendreon in the coming years.

We upgrade DNDN to Buy. Our price target is $25.00. 

Published in