New Study Released Today Shows Patients With Deadly Form of Lung Cancer Lived Longer Without Disease Worsening

By Eli Lilly And Company, PRNE
Saturday, June 4, 2011

BASINGSTOKE, England, June 5, 2011 -

- Pivotal Phase III ALIMTA study met primary endpoint

Eli Lilly and Company Limited announced today that PARAMOUNT(1), Lilly
Oncology's Phase III study evaluating ALIMTA(R) (pemetrexed for injection) in
the continuation maintenance setting, met its primary endpoint of
progression-free survival, or the time a patient is alive without their
disease worsening, for patients with a specific type of lung cancer called
advanced nonsquamous non-small cell lung cancer (NSCLC).

"Continuation maintenance" treatment is when one of the same medicines
used in first-line treatment setting is continued as maintenance therapy in
an effort to control the cancer.

Results from the study will be presented on Sunday, June 5 at 11:30 a.m.
during the Lung Cancer Oral Abstract Session (Abstract #CRA7510) at the
47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, Ill. Lilly will present overall survival results from PARAMOUNT at a
medical meeting in the future.

PARAMOUNT is the second study to evaluate the use of pemetrexed as a
maintenance therapy in patients with advanced nonsquamous NSCLC, and the
first study to evaluate the use of continuation maintenance with
pemetrexed(2) following first-line pemetrexed plus cisplatin therapy.

Results of this multicentre, double-blind trial demonstrated the median
progression-free survival measured from randomization (after first-line
treatment) was 3.9 months on the pemetrexed arm as compared to 2.6 months on
the placebo arm with a hazard ratio of 0.64. Said another way, the study
showed that pemetrexed continuation maintenance arm resulted in a 36 percent
improvement of survival without disease worsening over the placebo arm. The
maintenance disease control rate, or the percentage of patients achieving
either a response or stable disease first measured at 6 weeks
post-randomization was 71.8 percent (2.8%/69.0%) on the pemetrexed arm and
59.6 percent (0.6%/59.0%) on the placebo arm.

"PARAMOUNT demonstrated that a pemetrexed continuation maintenance
regimen — single-agent pemetrexed following pemetrexed plus cisplatin
induction therapy — can improve progression-free survival in patients with
the most common form of lung cancer," said Allen S. Melemed, M.D., M.B.A.,
pemetrexed medical product development leader at Lilly Oncology. "This
finding continues to validate the use of pemetrexed maintenance treatment for
certain patients living with this devastating disease."

A total of 939 patients with advanced nonsquamous NSCLC were enrolled in
the study and received pemetrexed (500 mg/m2 on day one of a 21-day cycle) in
combination with cisplatin (75 mg/m2) induction therapy. Patients whose
disease had not progressed during the pemetrexed+cisplatin induction and had
a performance status of 0-1 (n=439) were randomized to receive pemetrexed
maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive
care (n=359) or placebo plus best supportive care (n=180) until disease
progression. All patients received vitamin B12, folic acid and dexamethasone.

Overall, the most serious (grade 3/4) drug-related adverse events (AEs)
were higher for those treated with pemetrexed continuation maintenance versus
placebo (9.2% vs. 0.6% laboratory and 8.9% vs. 4.4% non-laboratory). The most
commonly reported drug-related AEs observed on the pemetrexed arm versus
placebo were anemia (4.2% vs. 0.6%), fatigue (4.5% vs. 0.6%), and neutropenia
(3.6% vs. 0%). There was one potentially drug-related death on each arm.
Discontinuations due to AEs were 5.3 percent with pemetrexed and 3.3 percent
with placebo.

The study was conducted in patients with advanced nonsquamous NSCLC
because past studies have shown that advanced NSCLC patients with a
nonsquamous histology (those with adenocarcinoma, large cell carcinoma, or
other subtypes) experienced improved efficacy over the relative comparator
arm in the trial (an increase in progression-free survival, as well as
overall survival), when treated with an pemetrexed regimen.(2,3) Patients
with advanced NSCLC with squamous cell histology were not included in the
PARAMOUNT study as pemetrexed has not shown to be effective in this patient
population relative to the comparators in these previous trials.


About Non-Small Cell Lung Cancer (NSCLC)

Globally, lung cancer is the most common form of cancer and the biggest
killer, causing over 1 million cancer deaths annually.(4) About 85 - 90
percent of all lung cancers are NSCLC.(5) The liver, bones and brain are
potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by
cellular structure. Nonsquamous histology includes adenocarcinoma and large
cell carcinoma, which account for more than half of all NSCLC diagnoses(6),
as well histologies classified as "other."

About Lilly Oncology

For more than four decades, Lilly Oncology, a division of Eli Lilly and
Company, has been dedicated to delivering innovative solutions that improve
the care of people living with cancer. Because no two cancer patients are
alike, Lilly Oncology is committed to developing novel treatment approaches.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organisations. Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most urgent
medical needs.

UKALM00327 June 2011


(1) Paz-Ares L. G et al. PARAMOUNT: Phase III study of maintenance
pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC
immediately following induction treatment with pem plus cisplatin for
advanced nonsquamous non-small cell lung cancer (NSCLC). ASCO Abstract
(CRA7510), Chicago, USA June 3-7 2011

(2) Ciuleanu T, et al. Maintenance pemetrexed plus best supportive care
versus placebo plus best supportive care for non-small-cell lung cancer: a
randomised, double-blind, phase 3 study. The Lancet, Vol. 374 No. 9699 pp
1432-1440, October 24, 2009.

(3) Scagliotti G, Purvish P, et al. Phase III study of pemetrexed plus
cisplatin versus gemcitabine plus cisplatin in chemonaive patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC). Abstract
PRS-3, 12th World Conference on Lung Cancer (WCLC) 2007. Journal of Thoracic
Oncology, Vol 2 No 8, Supplement 4, Page S306, August 2007.

(4) World Health Organization, Gender in Lung Cancer and Smoking
Research, Department of Gender, Women and Health, 2003,, (April 20, 2011).

(5) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
December 16, 2010, American Cancer Society,,
(April 20, 2011).

(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
October 20, 2009, American Cancer Society,,
(April 20, 2011).

The licensed indications of Alimta are contained in the full Summary of
Product Characteristics that is available here:

(Logo: )

Lilly Press Office, 01256-315000, GB_CA_Mediaenquiries at; or Grainne Maguire, TogoRun, 0207-554-1813, Mobile: 07540-002009, G.Maguire at

Health News

Eli Lilly and Company News

will not be displayed