* Delays progression of disease by 1.3 months
* Well-tolerated in those who received earlier treatment
By Ransdell Pierson and Bill Berkrot
NEW YORK, June 5 Continued use of Eli Lilly and
Co's (LLY.N) lung cancer drug Alimta delayed worsening of the
disease among patients who had taken an initial treatment
regimen with the blockbuster medicine, according to a
Alimta currently has annual sales of more than $2 billion,
making it Lilly's third-biggest product, and the trial's
further validation of its use as a maintenance treatment could
drive sales higher.
Alimta is already approved in combination with the
chemotherapy agent cisplatin as a first-line, or initial
treatment option. It is also approved as maintenance therapy,
to delay disease return or progression, among patients who have
initially been treated with chemotherapy.
With data from this new Paramount trial in hand, Lilly said
it will ask U.S. regulators to approve Alimta as maintenance
therapy for patients who received the drug as part of their
Cancer drugs are increasingly being tested as maintenance
therapy, meaning they could be given for months or years to
keep the disease at bay. Until recently patients who were
stable after receiving treatment were not given other medicines
until the disease began to worsen.
The 939-patient study, presented at the annual meeting of
the American Society of Clinical Oncology in Chicago on Sunday,
included subjects with the nonsquamous form of non-small cell
lung cancer -- the most common type of lung cancer which
affects an estimated 1.1 million Americans.
Patients received initial treatment with four courses of
Alimta and cisplatin. Those whose disease did not return or
worsen after initial treatment were divided into groups that
received either Alimta as a maintenance therapy or a placebo.
The study showed that patients receiving maintenance
treatment with Alimta went an average of 3.9 months without
disease progression. That compared with 2.6 months for those
The 1.3 month delay is in line with that typically seen for
other newer treatments, said Dr. Luis Paz-Ares, chairman of
oncology with Hospital Universatario Virgen del Rocio in
Seville, Spain, who led the trial.
Although the 1.3 month delay might seen as negligible at
first glance, Paz-Ares said it represented a 36 percent
improvement over patients not receiving the Lilly medicine.
In future years, he said newer drugs will hopefully produce
more impressive delays.
"We're increasing step by step to improve overall results,"
Patients in the Paramount study will be followed to assess
how long Alimta actually prolongs life. It prolonged survival
by five months in an earlier trial, among patients with the
same nonsquamous form of the lung cancer, Paz-Ares said.
"The drug is well-tolerated, which is a reason many
patients accept maintenance therapy," he added.
Although there were more side effects among the Alimta
group in the latest trial than those receiving placebos, they
were far less burdensome than adverse events typically seen
Some 9.2 percent of patients taking the Lilly drug had
serious adverse events, as measured in the laboratory, compared
with 0.6 percent for those receiving placebos. The most common
side effect was anemia, which affected 4.2 percent of those on
Alimta, versus 0.6 percent of those getting placebos.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by