Pharma Strategy Blog

Like many, I missed this press release on Friday afternoon, but it seems that at least there was some media pick up, such as the article from The Star Tribune in Minnesota.

Any time you see the words 'study halted over safety concerns' you know the news isn't going to be cheering.  In this case, six patients experienced heart symptoms, the symptoms of which include shortness of breath and fatigue, along with swelling in certain parts of the body.  Now, granted cardiotoxicity is a known complication of anthracyclines (AC), which were also taken by the patients in addition to the tested drug, Avastin (bevacizumab). 

Clearly, we will have to wait and see if the effect was due to AC alone or whether Avastin potentiates the effect in any way.  Avastin has been show to increase vascular side effects such as hypertension, a known adverse event associated with the VEGF class of drugs, but the news isn't good for Roche/Genentech, especially after the failure of the drug in colorectal cancer earlier this year, also in the adjuvant setting:

"Enrollment into E5103 began in November 2007 and 3,439 of the planned 4,950 patients have been entered into the study."

Of course, as luck would have it, the cardiac issues arise after nearly 70% of the patients have been enrolled, exposing the majority of them to the combined effects of both the anthracyclines and the bevacizumab toxicities.  While 6 patients out of 3,439 isn't a lot (less than 0.2%), it will be interesting to see whather this is an expected anthracycline problem or an increased potentiated by two drugs that impact the vascular system.