Biotech Values

[DewDiligence]

ONXX BAY PFE WYE
Nexavar Misses Survival Goal; Shares Fall

[The early unblinding of this trial in 2005 based on stellar PFS data and the consequent allowance of crossovers from placebo to Nexavar hurt the chance of achieving a statsig outcome in overall survival.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060605:MTFH64952_2...

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Mon Jun 5, 2006 12:05 PM ET
By Toni Clarke

ATLANTA, June 5 (Reuters) - The kidney cancer drug Nexavar, which was approved last December after it proved to slow tumor growth, failed to significantly increase survival in a late-stage trial, its makers, Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. said on Monday.

Shares of Onyx, which were already down after positive news on two competing kidney cancer drugs was released on Sunday, fell further after the Nexavar news, losing more than 16 percent to hit a more than two-and-a-half-year low.

New data from the Phase III trial, released at the annual meeting of the American Society of Clinical Oncology in Atlanta, showed that patients taking Nexavar had a median survival of 19.3 months, compared with 15.9 months for those receiving a placebo. The results were not statistically significant.

The companies said the trial is continuing.

Nexavar is competing with Pfizer Inc.'s new kidney cancer drug Sutent, which was approved in January, and will likely also compete with a drug being developed by Wyeth which shows promising results.

Friedman Billings Ramsey analyst Jim Reddoch said that based on new Sutent data presented at the ASCO meeting on Sunday, Pfizer's drug will likely be the new standard of care in kidney cancer.

Also on Sunday, Wyeth said interim results of a late-stage trial showed its experimental kidney cancer drug, temsirolimus, significantly increased survival [#msg-11426914].

At this point, the Onyx data is consistent with earlier data from the trial that showed an improvement in overall survival of 39 percent in those taking Nexavar, which was not statistically significant.

Shares of Onyx were down $2.96 to $16.87 in midday trade on Nasdaq, after earlier falling as low as $16.53.

Dr. Tim Eisen, who is consultant medical oncologist at The Royal Marsden Hospital in London and who presented the latest Nexavar data, said he expects final survival results of the trial to be available this November.

Eisen said he thinks there will be room on the market for all three of the new drugs. Initially, he said, it is likely that Sutent will be preferred as there is more data about the drug in patients who have not been previously treated.

Data presented over the weekend showed that previously untreated patients who took Sutent had an average period of 11 months before their disease progressed, compared with 5 months for those taking the standard treatment interferon.

Data about Nexavar in previously untreated patients is not yet available, but in patients who failed previous treatments Nexavar prolonged the period before the disease progressed to 24 weeks from 12 weeks.

The trial tested more than 900 patients with advanced kidney cancer who had failed previous therapy. The main goal of the study was a statistical improvement in overall survival. The results presented Monday were based on an analysis of 367 patient deaths. Final analysis will be conducted when 540 patient deaths have occurred, the company said.

In April 2005, the trial was unblinded and patients who were receiving a placebo could "cross over" to treatment with Nexavar because the length of time before the disease progressed had doubled for patients on Nexavar. [This was the problem!]

Nearly 50 percent of patients crossed over into the Nexavar group.
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