Key Tarceva Study May Disappoint Amid Cancer Data Releases

A massive release Thursday of more than 4,000 cancer studies included positive results for Genomic Health Inc. (GHDX) and Eli Lilly & Co. (LLY), and an unimpressive outcome for Tarceva, the therapy sold by OSI Pharmaceuticals Inc. (OSIP) and Roche Holding AG's (RHHBY) Genentech unit.

The studies were published by the American Society of Clinical Oncology two weeks before the group's major annual meeting in Orlando, Fla. This is the second year that ASCO has publicly released the summaries of studies early in order to prevent leaked information from affecting stock trading.

The Tarceva study, known as Saturn, measures the therapy's use in lung cancer as a maintenance therapy - when it is given after chemotherapy but before new tumor growth.

The study shows that patients receiving Tarceva had a median progression-free survival of 12.3 weeks, compared to 11.1 weeks for those on placebo. The week-plus difference is likely disappointing to those looking for something similar to the two-month spread seen with Lilly's Alimta.

OSI Chief Executive Colin Goddard conceded that Wall Street would look at the survival figure, but believes it will be a "non-event" after physicians see the full data.

The company noted that the figures are not representative of patient benefit because of data distribution. Goddard said the average benefit was about 22 weeks in Tarceva patients, compared to 16 weeks on placebo.

Goddard is confident that maintenance use of Tarceva could add more than $500 million in annual U.S. sales in one to three years after expanded approval, expected in early 2010.

In 2008, Tarceva had U.S. sales of $457 million and worldwide sales of $1.12 billion. OSI splits U.S. sales with Roche and gets a 20% royalty on overseas sales.

Tarceva is currently approved for use as a later treatment in advanced lung cancer patients who have progressed after at least one prior chemotherapy regimen. Applications for expanded approval have been filed in Europe and the U.S.

 
   Other Studies 
 

- Data from a large late-stage trial of Genentech's Avastin, called RIBBON-1, show the drug extended progression-free survival in advanced breast cancer patients - by nearly three months, on a median basis - when used with Roche's chemotherapy pill Xeloda.

When used with other commonly used chemotherapies, taxane or anthracycline, Avastin improved progression-free survival by a little more than a month.

The data was shared with the FDA to support full approval in the indication after the agency granted accelerated approval last year.

The study didn't meet a secondary goal of showing improvement in overall survival, but data will continue to be collected. A Genentech spokeswoman warned that the study is unlikely to meet that goal because patients were eligible to get Avastin with second-line chemotherapy after their disease progresses, which makes it hard to measure survival.

- A study showed a gene-based test being developed by Genomic Health met a goal of predicting the likelihood of recurrence of colon cancer for certain patients following surgery. The test, the Oncotype DX, is currently being used to help determine whether chemotherapy should be added to hormone treatment for some women with breast cancer.

The study's lead researcher, David Kerr, professor of cancer medicine at the University of Oxford, said the test was good at distinguishing low-risk patients from those facing a high risk of cancer returning. The test didn't meet a secondary goal of predicting how a patient would respond to chemotherapy. Genomic Health expects to have an Oncotype colon cancer test on the market next year.

- Data showed that adding Lilly's Gemzar to another chemotherapy drug cisplatin cut the risk of death and tumor growth in patients with advanced cancer of the gallbladder and bile duct.

The study looked at 410 patients and showed those receiving Gemzar in addition to cisplatin lived for an average of three months longer than those receiving cisplatin alone, which researchers said translated into a 32% reduction in the risk of dying.

-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; [e-mail]

(Jennifer Corbett-Dooren contributed to this story)