UPDATE: Pfizer Halts Enrollment In Lung-Cancer Drug Trial
October 09 2009 - 4:20PM
Dow Jones News
Pfizer Inc. (PFE) has temporarily halted enrollment of new
patients in a clinical trial of an experimental lung-cancer drug,
saying the drug was associated with a higher rate of adverse
events, including fatalities, than those who didn't get the
drug.
The drug is figitumumab, also known as CP-751,871. It was in a
Phase 3, or late-stage, trial in patients with a form of the
disease known as non-adenocarcinoma non-small cell lung cancer.
The trial began around March 2008 and was projected to have
about 820 patients before ending in 2011, according to a U.S.
government clinical-trial database. Some of the patients were given
figitumumab in addition to the drugs paclitaxel and carboplatin,
while others received paclitaxel and carboplatin only.
Pfizer said in a written statement Friday that an independent
committee monitoring drug safety found there were more serious
adverse events, including deaths, in people who received the Pfizer
drug. Pfizer didn't immediately disclose the number of such
events.
It was the latest research setback for New York-based Pfizer,
which has struggled to bring successful new drugs to market to
offset lost revenue from patent expirations for current
best-sellers. Pfizer, maker of blockbuster cholesterol drug Lipitor
and erectile-dysfunction drug Viagra, is in the process of
acquiring Wyeth (WYE) partly to beef up its research efforts.
Pfizer is temporarily halting new enrollment of patients in the
figitumumab trial, but currently enrolled patients may continue
their treatment in accordance with the trial design and in
consultation with their doctors. The company will work with the
drug-safety committee to analyze the data before issuing further
guidance.
A separate study, which tests figitumumab with the drug Tarceva,
continues to enroll new patients, Pfizer said. Tarceva is
co-promoted by OSI Pharmaceuticals Inc. (OSIP) and Roche Holding AG
(RHHBY).
Figitumumab belongs to a class of drugs known as IGF-1R
inhibitors, which block a substance in the body known as
insulin-like growth factor. The mechanism exploits research
suggesting that insulin-like growth factor can stimulate cancer
cells.
Several other companies are developing drugs with similar
mechanisms, including Merck & Co. (MRK) and Eli Lilly & Co.
(LLY) and Biogen Idec Inc. (BIIB). Most are biologics, which means
they're developed using living cells rather than traditional
chemicals.
If they're successful, the IGF-1R drugs could be lucrative.
Research firm Leerink Swann previously estimated Pfizer's compound,
which is one of the furthest along in patient trials, could
generate peak annual sales exceeding $1 billion.
But even before the safety issue emerged in the Pfizer trial,
there was a known theoretical risk to this class of drugs: Just as
giving insulin therapy to diabetics can help control blood sugar,
blocking the effects of insulin or similar substances in cancer
patients could lead to excess blood sugar, a marker of
diabetes.
An earlier-stage study of figitumumab showed it to be associated
with higher rates of hyperglycemia than those not taking the drug.
Still, some doctors think this is a manageable side effect, with
non-insulin drugs such as metformin able to control high blood
sugar.
It wasn't immediately known whether hyperglycemia or related
conditions were a factor in the adverse events or deaths in the
halted Pfizer trial. It's also not clear whether the safety issues
with the Pfizer drug are specific to the drug itself or represent a
"class effect" that would spell trouble for other companies'
drugs.
A spokeswoman for Biogen, whose IGF-1R inhibitor is in
early-stage studies, said the compound has shown a favorable
clinical safety profile, with no hyperglycemia or a blood-platelet
disorder observed.
The biological basis for a link between insulin and cancer was
behind studies published in the summer which suggested that
Sanofi-Aventis's (SNY) insulin product Lantus raised the risk of
cancer. Sanofi and health authorities have said those studies were
inconclusive, but Sanofi recently announced it would conduct
research to help resolve the debate.
The Pfizer trial's halt was reported earlier by CNBC.
Pfizer shares rose 24 cents to $16.94 in recent trading
Friday.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com
(Thomas Gryta in New York contributed to this article.)