Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes
September 25 2007 - 6:00AM
PR Newswire (US)
Lilly Studies Predictive Factors to Better Target Patients for
ALIMTA(R) (pemetrexed for injection) in the Treatment of Non-Small
Cell Lung Cancer BARCELONA, Spain, Sept. 25 /PRNewswire-FirstCall/
-- In clinical research, patients with advanced non-small cell lung
cancer (NSCLC) that are classified as having a non-squamous
histology achieve statistically significant higher survival when
treated in the second-line setting with ALIMTA(R) (pemetrexed for
injection) when compared to histologically-similar patients treated
with docetaxel. The data (ECCO Abstract # 6521)(1) were presented
at the 14th European Cancer Conference (ECCO) in Barcelona. ALIMTA,
manufactured and marketed by Eli Lilly and Company, is currently
indicated for the second-line treatment of advanced NSCLC in more
than 85 countries. The retrospective analysis of Phase III data(2)
consisted of 571 patients. The analysis showed that non-squamous
patients treated with ALIMTA achieved a statistically higher
overall survival compared to those treated with docetaxel (9.3
months and 8.0 months, respectively; hazard ratio 0.778 [95% CI
0.607- 0.997]). Conversely, the analysis suggested that patients
with a squamous histology and treated with docetaxel had a
statistically higher overall survival compared to those treated
with ALIMTA (7.4 months and 6.2 months respectively; hazard ratio
1.563 [95% CI 1.079, 2.264]). Patients with a non- squamous
histology represented the majority of the patients on the trial.
The retrospective analysis was driven by preclinical data that
suggested patients with a lower expression of thymidylate synthase
(TS) enzyme show an increased efficacy when treated with
ALIMTA.(3,4) The histological type of NSCLC is determined by how
the cancerous cells appear under a microscope. Two of the most
common histological types of NSCLC are adenocarcinoma and large
cell carcinoma (5) and constitute approximately 55 percent of all
NSCLC diagnoses.(6) These two subgroups, and any other types not
identified as squamous, were considered non-squamous for this
analysis. "This particular analysis suggests that histology may
play an important role in determining patients who are most likely
to receive a larger treatment result from ALIMTA," said Patrick
Peterson, Ph.D., principal research scientist at Lilly and
principal author of the analysis. Patients on the ALIMTA arm were
treated with ALIMTA (500 mg/meters squared) supplemented with
vitamin B12 and folic acid. Patients on the docetaxel arm were
treated with docetaxel (75 mg/meters squared). Data from a second
trial (ECCO Abstract # 6560)(7) detailed additional predictive
factors for a patient's potential benefit from treatment with
ALIMTA. In a Phase II prospective study, researchers in Japan
evaluated the survival outcomes of 216 patients with locally
advanced or metastatic NSCLC who were treated with ALIMTA in the
second-line setting. The data suggested that favorable predictive
factors for ALIMTA treatment in the second-line NSCLC setting could
include the following: female patients; patients with
adenocarcinoma histology; patients with a longer interval since
their previous chemotherapy treatment; patients with good
performance status, and; those diagnosed in the early clinical
stage. "Cancer treatment continues to move in the direction of
tailoring therapies to meet the needs of the specific types of
cancers and patients," said Richard Gaynor, M.D., vice president,
cancer research and global oncology platform leader for Lilly. "Our
goal is to further explore the biologic rationale for this
observation in non-squamous histology and work toward developing a
biomarker approach to determine when ALIMTA is the right drug for
the right patient." ALIMTA, as a single agent, was approved by both
the European Medicines Agency (EMEA) and the U.S. Food and Drug
Administration (FDA) in 2004 for the treatment of patients with
locally advanced or metastatic NSCLC after prior chemotherapy. The
effectiveness of ALIMTA in second-line NSCLC was based on the
surrogate endpoint, response rate. There are no controlled trials
demonstrating a clinical benefit, such as a favorable survival
effect or improvement of disease related symptoms. About Non-Small
Cell Lung Cancer (NSCLC) NSCLC is the most common type of lung
cancer and represents 75-80 percent of all lung cancers. NSCLC has
five-tier staging, starting at 0 and rising to the severity of
stage IV. NSCLC can spread through the lymphatic system,
penetrating the chest lining, ribs, and the nerves and blood
vessels that lead to the arm. The liver, bones and brain are
potential targets if the cancerous cells enter the blood stream.
About Lilly Oncology, a Division of Eli Lilly and Company For more
than four decades, Lilly Oncology has been collaborating with
cancer researchers to deliver innovative treatment choices and
valuable programs to patients and their physicians. Inspired by
courageous patients living with cancer, Lilly Oncology is providing
treatments that are considered global standards of care and
developing a broad portfolio of novel targeted therapies to
accelerate the pace and progress of cancer care. To learn more
about Lilly's commitment to cancer, please visit
http://www.lillyoncology.com/. About Eli Lilly and Company Lilly, a
leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. P-LLY ALIMTA(R) (pemetrexed for
injection), Lilly docetaxel (Taxotere(R)), Sanofi-Aventis This
press release contains forward-looking statements about the
potential of ALIMTA for the treatment of non-small cell lung cancer
and reflects Lilly's current beliefs. However, as with any
pharmaceutical product under development, there are substantial
risks and uncertainties in the process of development,
commercialization, and regulatory review. There is no guarantee
that the product will receive additional regulatory approvals.
There is also no guarantee that the product will continue to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. ALIMTA ALIMTA in combination
with cisplatin is indicated for the treatment of patients with
malignant pleural mesothelioma whose disease is unresectable or who
are otherwise not candidates for curative surgery. ALIMTA as a
single agent is indicated for the treatment of patients with
locally advanced or metastatic non-small cell lung cancer after
prior chemotherapy. The effectiveness of ALIMTA in second-line
NSCLC was based on the surrogate endpoint, response rate. There are
no controlled trials demonstrating a clinical benefit, such as a
favorable survival effect or improvement of disease-related
symptoms. Important Safety Information Myelosuppression is usually
the dose-limiting toxicity with ALIMTA therapy. Contraindication
ALIMTA is contraindicated in patients who have a history of severe
hypersensitivity reaction to pemetrexed or to any other ingredient
used in the formulation. Warnings ALIMTA should not be administered
to patients with a creatinine clearance