The American Society of Hematology annual meeting wrapped up yesterday, and as with pretty much every medical meeting, we've got some winning and losing blood-cancer drugs.
One-hit wonder goes for two
Onyx Pharmaceuticals
Maybe investors had forgotten? More likely they were just relieved that the presentation of the full data set lived up to the top-line hype. Carfilzomib is pretty impressive, causing a 24% response rate in patients who have previously failed a median of five prior lines of therapy, including drugs such as Johnson & Johnson and Takeda's Velcade and Celgene's
Onyx also took a bit of a hit when it announced in October that the Food and Drug Administration had concerns with the scale-up of the manufacturing of carfilzomib. While the full data set doesn't make it easier for the company to solve the problem, the data may have convinced investors that the drug is worth the wait.
Not so lucky
Seattle Genetics
I don't think you should read much into that, though. Shares are up nearly 50% on the year, including a big run in September after the initial data on SGN-35 was released. Investors have already priced in the good news.
The next move for Seattle Genetics will be getting its marketing application accepted by the FDA early next year. Even with the outstanding data, gaining an accelerated approval with phase 2 data isn't easy. For instance, the FDA refused to even look at Roche and ImmunoGen's trastuzumab-DM1 accelerated approval application for their breast cancer drug. While I don't think that'll happen with SGN-35, it shows what Seattle Genetics is up against.
Failed trial! Who cares?
We can put Pfizer's
Bosutinib did beat Gleevec in its secondary endpoint, major molecular response, by a substantial margin, 39% to 26%. Pfizer figures being about as good in one category and better in another is enough to get the drug on the market, and it plans to seek regulatory approval next year.
But Novartis and Bristol-Myers Squibb
Side effects got you down
The biggest loser at ASH was clearly Celgene. The company is trying to get Revlimid approved as a first-line treatment and for maintenance use to keep multiple myeloma from coming back. Early and often is a nice prescription for increased sales.
Revlimid clearly helps patients, but the ASH data revealed a larger number of secondary tumors in patients taking Revlimid than those taking placebo. Curing cancer is great, but not if you just cause another one.
The numbers are small. The effect might not be real. But until investors are convinced, the potential secondary tumor effect will hang over the stock.
Green blood
As Celgene's rise to mid-cap-biotech status has shown, there's plenty of money to be made off blood-cancer drugs. Both carfilzomib and SGN-35 look very promising. Just keep in mind that not every drug works, and even when they do get on the market, there's still risk when new data are presented.
Did I miss any winners or losers? Let us know in the comment box below.
