Studies Show Bayer, Boehringer Ingelheim Drugs Slow GIST, Lung-Cancer Growth
June 04 2012 - 12:31AM
Dow Jones News
A study involving an experimental Bayer AG (BAYRY, BAYN.XE)
cancer drug, regorafenib, showed it delayed the progression of a
rare type of gastrointestinal tumor in patients who had been
previously treated with other drugs.
BayerHealthcare, a Bayer unit, announced last month that it had
submitted an application to the U.S. Food and Drug Administration
seeking approval for regorafenib to treat patients with advanced
colon cancer, and plans to submit an application as a treatment for
gastrointestinal stromal tumors, or GIST, later this year.
The study looking at regorafenib in GIST involved 199 patients
who had been previously treated with Novartis AG's (NVS, NOVN.VX)
Gleevec or Pfizer Inc.'s (PFE) Sutent. The patients tumors had
become resistant to Gleevec and Sutent, which is not uncommon as
cancer finds new ways to grow. Researchers, led by George Demetri
of the Dana-Farber Cancer Institute in Boston, said regorafenib
targets an enzyme called KIT along with other pathways cancer uses
to grow.
Two-thirds of the patients were given regorafenib while
one-third of the patients were given a placebo drug. The study was
designed to measure progression-free survival, which is a
measurement of the time from the start of treatment until the
disease gets worse or the patient dies. Patients in the placebo
were offered regorafenib if their disease progressed.
The study showed median progression-free survival was 4.8 months
in the patients receiving regorafenib compared with 0.9 month for
patients in the placebo group. Because most patients in the placebo
group were later treated with regorafenib, there was no
statistically significant difference in overall survival, Dr.
Demetri said.
The most common drug side-effects were hand-foot skin reactions
like redness, swelling and pain, high blood pressure and
diarrhea.
Separately, a study looking at another experimental drug
afatinib, which is being developed by Boehringer Ingelheim
Pharmaceuticals Inc. for use in some types of lung cancer, showed
it slowed disease progression.
The study, also due for presentation Monday at ASCO, involved
345 patients whose cancers tested positive for a mutation called
EGFR. That type of lung cancer is commonly seen in people who have
never smoked and are of Asian descent.
About two thirds of the patients received afatinib and one-third
received a combination of chemotherapy drugs pemetrexed and
cisplatin, common lung-cancer treatments. The study showed patients
treated with afatinib had a median progression-free survival of
11.1 months compared to 6.9 months for the chemotherapy group.
Overall survival data aren't expected for about two years.
-By Jennifer Corbett Dooren, Dow Jones Newswires;
jennifer.corbett@dowjones.com