UPDATE: Key Tarceva Study May Disappoint Amid Cancer Data

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 aren't 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.

A Phase III study looking at pazopanib, a drug being developed by GlaxoSmithKline (GSK) to treat kidney cancer, showed it prolonged progression-free survival by five months in patients with advanced kidney cancer. There isn't yet enough data to show if patients receiving pazopanib lived longer.

-A Phase III study of thalidomide, sold by Celgene Corp. (CELG) to treat certain blood cancers, failed to show any benefit in lung cancer patients when used with chemetherapy or radiation therapy. The trial, conducted by a cooperative group, was halted after the third interim analysis due to futility.

-A Phase II study of Trastuzumab-DM1, from Genentech and Immunogen Inc. (IMGN), showed the drug shrank tumors in 25% of women with advanced breast cancer that had progressed following previous treatment with HER2-targeted therapies. One adverse event leading to death was reported in the trial.

Trastuzumab-DM1 is a new type of drug called an antibody conjugate that has Genentech's blockbuster cancer drug Herceptin attached to the Immunogen's cell-killing DM-1. The idea is to seek the cancer with the antibody, then kill it.

-A study of Nexavar, marketed by Bayer AG (BAY) and Onyx Pharmaceuticals Inc. (ONXX), used in combination with ZymoGenetics (ZGEN) IL-21, suggested the combination was well-tolerated in kidney cancer patients.

Researchers said the Phase II study showed the combination was "feasible" and improved tumor shrinkage, disease-control rate and progression free survival compared to Nexavar alone.

-Another Phase II study of Nexavar in advanced thryoid-cancer patients showed patients treated with the drug experienced progression-free survival of 84 weeks. The research also showed patients whose tumors had a mutated gene form of a gene known as BRAF had much longer progression free survival than tumors with the naturally occurring form of the gene.

Nexavar is currently approved in the U.S. as a liver and kidney cancer treatment.

-Exelixis Inc.'s (EXEL) XL184 "demonstrated substantial activity" in a small ongoing Phase II study in treating progressive or recurrent glioblastoma multiforme, a form of brain cancer, in first or second relapse. The study showed that more than half of the 46 patients in the trial have required a dose interruption or reduction due to side effects.

Bristol-Myers Squibb Co. (BMY) signed a co-development pact for the drug late last year.

-Arqule Inc.'s (ARQL) ARQ-197 showed "preliminary evidence of anti-cancer activity" in interim data from a mid-stage trial of in Microphthalmia Transcription Factor, or MiT, tumors - a group of cancers that tend to affect young adults. The drug, partnered with Japan's Daiichi-Sankyo Co. (4568.TO), seems to have a clean safety profile, with no serious adverse events in the study.

-Thomas Gryta, Dow Jones Newswires; 201-938-2053; [e-mail]; and Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]