* MAGE-A3 fails to hit goal in Phase III lung cancer trial
* Setback follows disappointing 2013 results in melanoma
* GSK hopes to find patient sub-set in which vaccine works
* Shares fall 2 percent
(Adds analyst comments, latest shares, further details)
By Ben Hirschler
March 20 An experimental cancer vaccine from
GlaxoSmithKline has failed in a second test - this time
against lung cancer - but the British company said it still
hoped to identify a sub-group of patients in which it would
Thursday's news that the MAGE-A3 therapeutic vaccine did not
help patients with non-small cell lung cancer in a late-stage
study is a further blow to the high-risk, high-reward project
after a similar setback in melanoma in September.
Unlike traditional preventative vaccines, the MAGE-A3
treatment is designed for people with established disease,
helping their immune systems to prevent the return of disease
The large Phase III study, involving more than 2,000 lung
cancer patients, found that the experimental therapy did not
help patients live longer without their disease recurring.
Nonetheless, GSK plans to continue the clinical trial in the
hope of finding a sub-population that will benefit. It is also
doing the same with patients suffering from melanoma and results
of analyses looking at these sub-sets of patients with
particular genetic profiles are expected in 2015.
Vincent Brichard, head of immunotherapeutics at GSK
Vaccines, said the company was disappointed by the outcome but
remained committed to the project.
Shares in GSK fell by 2 percent by 0945 GMT, underperforming
a 0.7 percent decline in the European drugs sector.
Many investors had been expecting a disappointing read-out
from the lung cancer study, following the earlier setback in
melanoma, and there are doubts as to whether GSK will be able to
prove the vaccine works for a smaller group of genetically
But despite the problems GSK Chief Executive Andrew Witty
painted a surprisingly upbeat picture of prospects for MAGE-A3
at full-year results last month. Witty described the cancer
vaccine and another drug for heart disease called darapladib
that has also disappointed in tests as among the most promising
in the company's pipeline.
10 PERCENT CHANCE
Citi analyst Andrew Baum said he estimated there was a 10
percent probability that MAGE-A3 could result in a significant
benefit in a gene-signature defined population group, which
would still be a substantial market.
As a result, Citi has a risk-adjusted sales forecast for the
product of 216 million pounds ($360 million) in 2022.
Other companies, including Bristol-Myers Squibb,
Roche and Merck & Co, have had some recent
notable successes in clinical trials of innovative drugs to
boost the immune system, but GSK is still pushing the scientific
boundaries with its vaccine-based approach.
So-called immunotherapy, in which the body's own immune
system is enlisted to fight tumour cells, is a hot area of
pharmaceutical research and development at the moment, although
cancer vaccines have proved difficult to develop over the years.
U.S.-based Agenus has contributed technology to the
GSK vaccine and its shares are sensitive to news on the project.
The vaccine contains Agenus' QS-21 Stimulon adjuvant, or
Although news on MAGE-A3 and darapladib has been
disappointing for GSK, the company's overall drug research has
been improving recently, with notable new drug approvals in 2013
for HIV, cancer and respiratory disease.
GSK, which is the only major drugmaker to report its
internal rate of return on R&D investment, said last month that
returns had now reached 13 percent, up from 12 percent two years
earlier and 11 percent in 2010. It has set a target of reaching
($1 = 0.6014 British Pounds)
(Additional reporting by Sarah Young; Editing by David Goodman
and Jane Merriman)