Biotech Values

[DewDiligence]

Crizotinib Blows Away Historical Controls in Early-Stage Study

[Crizotinib has a PDUFA date in Sep/Oct 2011 and has also been submitted in Japan (#msg-63205025).]

http://www.reuters.com/article/2011/05/18/cancer-pfizer-lung-idUSN1829964720110518

›Wed May 18, 2011 7:54pm EDT
By Bill Berkrot

NEW YORK, May 18 (Reuters) - More than 60 percent of lung cancer patients who received Pfizer (PFE) Inc's crizotinib in an early stage clinical trial were still alive after two years, according to data released on Wednesday.

While the drug was not compared to other medicines or placebo -- a higher standard of clinical trial -- the results marked the first overall survival data from the closely watched Pfizer drug.

Crizotinib could eventually reach annual peak sales of $2.5 billion, according to Morningstar analyst Damien Conover.

Pfizer on Tuesday filed applications seeking U.S. and Japanese approval for the drug considered among the most important in its developmental pipeline. The U.S. Food and Drug Administration has given it priority review status and the drug could gain approval by the end of 2011.

Crizotinib is an oral drug from a new class of cancer medicines that inhibits a gene called anaplastic lymphoma kinase, or ALK. Alterations of ALK are believed to be a driver of tumor development in certain cancers.

About four percent of lung cancer patients tend to be ALK positive, but about 10 percent to 15 percent of lung cancer patients who were never smokers fall into the category, researchers said.

In the study of 82 previously treated patients with ALK positive non-small cell lung cancer who received crizotinib, 77 percent were alive after one year and 64 percent were still alive after two years, data from an abstract, or brief summary of the study, showed.

Median overall survival data was not yet available, meaning more than half the patients were still alive. The study is due to be presented at the American Society of Clinical Oncology meeting in Chicago in early June.

A subset of patients in the Phase I study was compared with historical records of similar ALK positive patients who were not treated with crizotinib. Using those comparisons, 71 percent who received the Pfizer drug achieved one-year survival versus 46 percent in the historical control group, while 61 percent achieved two-year survival versus just 9 percent in the control group.

"We already know that crizotinib has impressive activity in terms of inducing responses," said Dr Alice Shaw, lead investigator for the overall survival study.

"This data suggests that crizotinib may prolong overall survival for these patients who have ALK in their lung tumors and may improve the natural history of disease," she said.‹