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;
thomas.gryta@dowjones.com; and Jennifer Corbett Dooren, Dow Jones
Newswires; 202-862-9294; jennifer.corbett@dowjones.com