Interim data show Aranesp no help in breast cancer

Interim data show Aranesp no help in breast cancer
LOS ANGELES (Reuters) - Amgen Inc said on Friday interimresults from an independent study involving breast cancerpatients found its anemia drug Aranesp did not enhance theeffect of chemotherapy prior to surgery.
Amgen shares fell 4 percent to $53 in extended trade as thecompany also reported preliminary follow-up data showing thatthe participants who received Aranesp had numerically moredeaths and reports of tumor growth than the control group.
The company cautioned that the results -- which land amidconcerns about the overuse and safety of the anemia drug class-- were preliminary and said no conclusions should be drawnuntil the final study report is completed.
The study, involving 733 patients, was designed to evaluatewhether Aranesp prevented anemia and augmented the therapeuticeffects of the chemotherapy regimens, Amgen said.
"This interim analysis shows that the use of Aranesp tosupport neo-adjuvant chemotherapy has no significant impact ontumor response to chemotherapy at the time of surgery," saidDr. Michael Untch, lead investigator of the study conducted bythe German Gynecological Oncology Study Group and the GermanBreast Group.
There were no deaths during the treatment period,researchers said.
Preliminary long-term follow-up data as of October 30 alsoshowed numerically more deaths in the group receiving Aranesp,50 of 356 patients, compared with 37 deaths among the 377 inthe control group.
There also were more tumor progression events in theAranesp group, 88 of 356, versus the control group's 70 of 377.
"No definitive conclusions should be drawn from the interimresults of the long-term follow up until the final study reportis completed," Untch said.
A formal statistical analysis of survival is anticipated inearly 2009.
Aranesp and its predecessor Epogen were Amgen's top-sellingdrugs in 2006, reaping combined revenue of $6.6 billion.
Sales of those Amgen drugs totaled $4.5 billion at the endof the third quarter, down 11 percent from the year earlier.
Anemia drugs, which also include products from Johnson &Johnson and Roche Holding AG, accounted for global sales ofabout $12 billion last year. They are used to treat anemia incancer and kidney dialysis patients.
The entire class has been under a microscope as debatesrage over whether anemia drugs increase the risk of heartattack and stroke, and whether they may play a role in fuelingthe growth of cancer.
Shares in Amgen, the largest U.S. biotechnology company byrevenue, are down 19 percent so far this year.
(Additional reporting by Bill Berkrot in New York)
(Editing by Braden Reddall and Andre Grenon)