Many observers, see Fierce Biotech and Forbes blog as examples, have declared that Bristol-Meyers Squibb and Pfizer were the really big winners at ASCO. BMS reported sterling results with its new cancer immunotherapy drug ipilumumab for the treatment of stage 4 melanoma patients - the drug increased mean survival from 6.4 to more than 10 months which by all accounts was impressive. Some analysts are projecting this to be a greater than $1 B a year drug.
Pfizer also reported good results for its lung cancer drug, crizotinib, which stopped disease progression in 87% of patients it was tested on. The drug is designed to be used with lung cancer patients exhibiting the ALK gene (5% lung cancer patients), as learned by Japanese researchers. The drug could hit $800 M in annual sales.
Other honorable mentions for the show include Roche for a very positive study with Avastin's use in the treatment of ovarian cancer. The results suggest the drug has a future in maintenance dosing for this and possibly other cancers.
Amgen's Prolia was also deservedly singled out. It received FDA approval recently for the treatment of osteoporosis but is also looking for an indication in the treatment of bone loss in other cancer patients. Should it achieve the latter approval, some analysts are projecting peak sales as much as $3 B per year.
The above describes the general consensus in the press coverage of ASCO. However, as always, there are other with differing or more tempered views, examples include pieces from the Pharmalot blog, the Forbes blog, and yet a third offering from the Forbes blog.
The first two blogs discuss BMS' unusual study design in the ipi melanoma trial. BMS chose to compare its drug to a vaccine instead of to a placebo or other treatment standards (there aren't many). This could make it difficult to predict how the FDA will interpret its application for approval. One big question is whether the control vaccine had any negative effects itself - thus making it a poor control. BMS seems confident that it has vetted this possibility and is confident in its positive results. And it better be, as BMS has several other cancer immunotherapy candidates in its pipeline acquired from Medarex for $2.3 B. Even the skeptical analysts on BMS chances of easy approval were increasing their annual peak sales estimates up to a range from $700 M - $1 B.
The last blog post from Robert Langreth acknowledges the apparent success of the BMS and Pfizer drugs, but points out that there were a lot more failures reported than big winners. This included failed trials involving Pfizer's Sutent (breast cancer), Roche's Avastin (colon cancer), and Lilly/BMS Erbitux (colon cancer). Big Pharma still hasn't found a fool-proof way to select and develop cancer therapies - and Langreth questions whether there is a rush to trial before the biology is really understood. Even treating patients at earlier stages (less advanced) of cancer did not always pan out - see colon cancer.
So in the end, it is still a mixed bag of cancer successe. It is clear there may be some significant new therapies approved with enviable sales projections. It is also true that there have been some dismal trial failures and a need to keep refining the way we go about developing and testing new therapies.
Posted by Bruce Lehr June 7th 2010.