By Hester Plumridge
LONDON--In the latest of a string of recent drug-development
setbacks, GlaxoSmithKline PLC on Tuesday stopped a late-stage trial
of its cancer vaccine after a series of disappointing results.
The U.K. drug company had announced March 20 that its
immunotherapy treatment, MAGE-A3, didn't boost survival rates among
patients with non-small-cell lung cancer, a prevalent form of the
disease.
Immunotherapies are a new form of cancer treatment that use the
body's own immune system to attack the cancer, rather than using
traditional chemotherapies or radiotherapies.
Glaxo continued with the trial despite the poor results in the
hope of finding a subset of patients who might benefit from the
treatment. It now says this will be impossible, because the vaccine
didn't have a big enough impact on patients.
Another late-stage study of MAGE-A3 last year failed to extend
survival in patients with melanoma. Glaxo is still hoping to
identify a subset of melanoma patients in which the vaccine might
work. Results are expected next year.
Despite the low probability many analysts ascribed to MAGE-A3
being successful in lung cancer, the sales opportunity was still
sizable given the number of patients with the disease. Melanoma is
a much less common form of cancer, meaning the sales opportunity is
smaller.
The failure of its cancer vaccine is a blow to Glaxo, which has
missed out on a new wave of immunotherapy drugs with exciting early
evidence of efficacy that has buoyed the share prices of rivals
Roche Holding AG, Bristol-Myers Squibb Co. and Merck & Co.
Glaxo has been struggling to offset falling sales from
established drugs that are losing patent protection. Sales of its
best seller, the asthma drug Advair, are being eroded by cheaper
alternatives in the U.S. and Europe.
Last year Glaxo managed to secure five new drug approvals in the
U.S. but investors are waiting to see if sales of new asthma and
respiratory disease drugs Breo and Anoro can offset falling
revenues from Advair.
Glaxo has also had a series of recent pipeline disappointments.
In November, it reported its heart-disease drug in development,
darapladib--once one of its brightest hopes--had failed to show any
meaningful effect on patients.
In late March, it withdrew a regulatory application in Europe
for use of its ovarian-cancer treatment Votrient in a new group of
patients with the disease.
Glaxo has also faced manufacturing and product-recall problems
in the past month.
U.S. regulators issued a warning letter to the company in March
after an inspection of a Glaxo manufacturing plant in Ireland found
contamination of drug ingredients used in the antidepressants Paxil
and Seroxat. The drug had been contaminated with material from the
plant's waste tank, the letter said.
Glaxo said it is assessing the concerns raised and is
considering a recall from wholesalers of certain batches of the
drug, although it said a medical assessment concluded there was no
risk of harm to patients.
Also last month, Glaxo issued a voluntary recall of all supplies
of its weight-loss pill Alli in the U.S. after concerns the bottles
were tampered with. Consumers in seven states reported bottles of
Alli that contained capsules and tablets that didn't look like the
drug or that were missing labels or seals.
Alli is manufactured in South Carolina and is a nonprescription
drug that blocks the stomach from absorbing some fat from food.
Analysts expected it to be a blockbuster with potential sales of
more than $1 billion when it was launched in 2007, but sales have
disappointed. Glaxo said it is investigating the potential
tampering issue.
Glaxo shares were down 0.4% at 1,587 pence in morning London
trading, having fallen more than 6% since March 4.
Write to Hester Plumridge at Hester.Plumridge@wsj.com
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