Re: Erbitux Fails Pancreatic Cancer Trial

4/11/2006 WSJ - Same song, second verse:

Another Pancreatic-Cancer Setback
In Study With Erbitux,
Overall Patient Survival
Wasn't Much Improved
By PETER LOFTUS
April 12, 2007; Page D7

Bristol-Myers Squibb Co. and ImClone Systems Inc. said their cancer
drug, Erbitux, failed to significantly prolong the lives of people
with pancreatic cancer in a new study, marking yet another setback in
the drug industry's efforts to find a better treatment for this deadly
disease.

Erbitux is currently approved by regulators to treat colorectal cancer
and head and neck cancer. Bristol-Myers and ImClone have been studying
whether it is effective in other cancers.


The latest study compared Erbitux plus Eli Lilly & Co.'s Gemzar with
Gemzar alone in 700 people with pancreatic cancer that is either
locally advanced and untreatable by surgery, or metastatic, which
means it has spread to other parts of the body. Gemzar is the current
standard of care for advanced pancreatic cancer. The trial didn't meet
its primary endpoint of improving overall survival. The companies
didn't release figures comparing survival times in each group.

The results make it unlikely the companies would seek regulatory
approval of Erbitux for pancreatic cancer in the manner it was given
in this study. However, the companies plan to pursue additional
evaluations of Erbitux in pancreatic cancer, including a pilot study
of the drug in combination with Genentech Inc.'s Avastin cancer drug.

"We still think Erbitux holds promise for pancreatic cancer, but this
trial obviously didn't work out," said Alexander Denner, chairman of
ImClone's executive committee.

Pancreatic cancer is one of the deadliest forms of the disease. About
33,730 new cases were estimated to be diagnosed in the U.S. last year,
with 32,300 people dying from the disease, according to the American
Cancer Society. Many die within months of diagnosis, and only about 4%
of pancreatic-cancer patients live at least five years. In comparison,
the average five-year survival rate for all cancers is about 65%.

Drug makers' effort to develop a better pancreatic-cancer treatment
has been littered with setbacks. Earlier this year, Threshold
Pharmaceuticals Inc. said its experimental drug didn't significantly
improve overall survival in a study of advanced pancreatic-cancer
patients. OSI Pharmaceuticals Inc.'s Tarceva was approved in 2005 to
treat pancreatic cancer, but its survival benefit is relatively
modest.

While the latest Erbitux study is bad news for pancreatic-cancer
patients, it may not represent a huge financial setback for ImClone
and Bristol-Myers. Pancreatic cancer is one of several types of cancer
for which Erbitux is being studied as a potential treatment. Big
market opportunities for Erbitux lie in additional uses in colorectal
cancer and in nonsmall cell lung cancer, which are more prevalent than
pancreatic cancer.

ImClone expects to report results from a study of Erbitux in lung
cancer by year end, Mr. Denner said. Bristol-Myers markets Erbitux and
pays ImClone royalties on the sales. Bristol-Myers reported 2006
Erbitux sales of $652 million, up 58% from 2005.

Erbitux has a new competitor in Amgen Inc.'s Vectibix, which was
approved by the Food and Drug Administration last year to treat
advanced colorectal cancer. But Vectibix had its own development
setback last month when Amgen said it dropped the drug from a study of
colorectal-cancer patients, citing safety concerns. The study was
testing a combination of Vectibix, Avastin and chemotherapy.

Write to Peter Loftus at peter.loftus@xxxxxxxxxxxx

Fig



.

Relevant Pages
Quantcast