Biotech Mailbag: Lessons From Clinical Trials

This column originally posted on RealMoney.com at 8:09 a.m. EDT. For more information about subscribing to RealMoney, please click here.

Let's open the Biotech Mailbag.

My post-mortem on the Cell Genesys (CEGE Quote) blowup prompted a lot of email, much of it complimentary, but some not so much.

Gordon writes:

"Love your Cell Genesys piece. I completely agree that single-arm Phase II data is one of the biggest causes of overinflated expectations. Even Genentech (DNA Quote) and Roche can fall victim. Think Avastin in pancreatic cancer. High company and investigator expectations due to a better patient profile in the Phase II study led to high expectations for the CALGB (U.S. study) and separate Roche studies. Let's hope the same thing doesn't happen to them in the AVAGAST study where expectations from Phase II having the Avastin-arm in AVAGAST beating control by two to three months. A difficult task in a difficult disease."

To fill in some of the blanks in Gordon's email, he's referring to a 2007 phase III study of Avastin in pancreatic cancer that failed to show a survival benefit.

The Avastin study in gastric cancer, known as AVAGAST and being conducted by Roche, is expected to complete patient enrollment in the first half of 2009.

The broader point I'd make is that there should be more companies emulating the Genentech model of clinical development, which emphasizes randomized, controlled phase II studies in almost every circumstance. Yes, these trials cost more money but they also greatly improve the odds for successful phase III studies. And isn't that what investors ultimately want -- fewer Cell Genesys-like blowups and more Genentech-like success stories?

The Dendreonites (or shall I call them Provengians?) seem to be angrier with me than normal, judging by the sharp spike in the amount of Dendreon (DNDN Quote)- related hate mail hitting my inbox. I only mentioned Dendreon in passing in the Cell Genesys column, but perhaps the outcry is a delayed reaction to my column on what to expect next year from the final analysis of the Provenge phase III study.