Study Showed ALIMTA(R) (pemetrexed for injection) Improved Survival in Certain Types of Non-Small Cell Lung Cancer
28 May 2008 - 10:00PM
PR Newswire (US)
Patients with Adenocarcinoma or Large Cell Carcinoma Histologies
Achieved Improvement in Overall Survival when Treated with
ALIMTA-based Regimen INDIANAPOLIS, May 28 /PRNewswire-FirstCall/ --
The type of non-small cell lung cancer (NSCLC) patients have may
now influence their treatment regimen and, in turn, survival
outcome according to the results of a major study published online
in the Journal of Clinical Oncology. Publication of the study was
announced by Eli Lilly and Company. The 1,725-patient study, the
largest Phase III clinical trial in the first-line NSCLC setting,
evaluated ALIMTA(R) (pemetrexed for injection) plus cisplatin
versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin, a
standard of treatment in this setting. The trial met its primary
endpoint of non-inferiority relative to overall survival.
Additionally, in a pre-planned histological analysis, patients with
either adenocarcinoma or large-cell carcinoma had a statistically
superior and clinically relevant improvement in overall survival
when treated with the pemetrexed regimen in the first-line setting.
In comparison, patients with squamous cell histology were found to
have a more favorable overall survival when treated with the
gemcitabine regimen. "While non-small cell lung cancer has
typically been treated as one disease, this study confirms that
histology, or tumor type, can provide a clue as to which treatment
regimen works best for a particular tumor type," said the study's
lead author, Giorgio Scagliotti, M.D., Department of Clinical and
Biological Sciences Thoracic Oncology Unit, University of Torino,
Orbassano, Italy. "If we can tailor the therapy for better results,
we are closer to improving outcomes for this terrible disease." The
overall survival of patients treated with either the pemetrexed
regimen or gemcitabine regimen was found to be non-inferior, with a
median survival of 10.3 months. However, when researchers reviewed
survival rates according to histological analysis, it was found
that patients with adenocarcinoma achieved 12.6 months of overall
median survival when treated with the pemetrexed regimen compared
to 10.9 months for those treated with the gemcitabine regimen.
Patients with large cell carcinoma who were treated with the
pemetrexed regimen achieved 10.4 months of overall median survival
versus 6.7 months for those treated with the gemcitabine regimen.
Both findings are statistically significant. Comparatively,
patients with squamous cell histology were found to have a more
favorable rate of survival when treated with the gemcitabine
regimen, achieving 10.8 months of median survival, compared to the
9.4 months for those treated with the pemetrexed regimen. This
finding also was statistically significant. The Phase III,
randomized study compared the overall survival between
pemetrexed+cisplatin versus gemcitabine+cisplatin in 1,725
chemonaive patients with stage IIIB or IV NSCLC who also exhibited
a performance status of 0-1. Patients on the pemetrexed arm (n =
862) were treated with pemetrexed (500 mg/m2) and cisplatin (75
mg/m2) on day one every three weeks for up to six cycles. Patients
on the gemcitabine arm (n = 863) were treated with cisplatin (75
mg/m2) on day one and gemcitabine (1250 mg/m2) on days one and
eight every three weeks for up to six cycles. Hematologic grade 3/4
drug-related toxicities - neutropenia, anemia and thrombocytopenia
- were significantly lower for patients on the pemetrexed arm (p
less than or equal to 0.001). Drug-related grade 3/4 febrile
neutropenia (p = 0.002) and alopecia (all grades; p < 0.001)
were also significantly less on the pemetrexed arm. However,
drug-related grade 3/4 nausea (p = 0.004) was more common in
patients treated with pemetrexed. Safety data by histology was
generally consistent with the overall safety results. "In research,
we're always looking for a new door to open - a different way of
looking at the problem, in the hope of finding a better solution.
That's why this study is so important. It has opened a door that
points to histology as a way of helping physicians decide which
lung cancer treatment may work best for a particular patient," said
Richard Gaynor, M.D., vice president of cancer research and global
oncology platform leader at Lilly. Notes to Editor About Non-Small
Cell Lung Cancer (NSCLC) NSCLC is the most common type of lung
cancer and represents 85 to 90 percent of all lung cancers.(1)
NSCLC has five-tier staging, starting at 0 and rising to the
severity of stage IV.(2) 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 bloodstream.
According to the World Health Organization (WHO) Cancer Report,
lung cancer is the world's most common cancer and the leading cause
of cancer death for both men and women. More than 1 million people
die from lung cancer each year.(3) NSCLC is defined as a group of
histologies, that is, tumor types differentiated by cellular
structure. The most common NSCLC histology types are squamous (or
epidermoid) carcinoma, adenocarcinoma, and large cell carcinoma.
These histologies are often classified together because, to date,
approaches to diagnosis, staging, prognosis, and treatment have
been similar.(4) 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/. (1) American Cancer Society,
"What Is Non-Small Cell Lung Cancer?," October 15, 2007, American
Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-
Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008). (2)
American Cancer Society, "How Is Non-Small Cell Lung Cancer
Staged?" October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-
Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21, 2008).
(3) World Health Organization, Gender in Lung Cancer and Smoking
Research, Department of Gender, Women and Health, 2003,
http://www.who.int/gender/documents/en/lungcancerlow.pdf. (4)
National Cancer Institute, "Non-Small Cell Lung Cancer Treatment
(PDQ(R)) Health Professional Version," December 14, 2007, National
Cancer Institute,
http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-
lung/HealthProfessional/page2, (February 14, 2008). 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 GEMZAR(R) (gemcitabine HCl for
injection), Lilly This press release contains forward-looking
statements about the potential of ALIMTA and GEMZAR 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 products will receive additional
regulatory approvals. There is also no guarantee that the products
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. Important
Safety Information for ALIMTA 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 25% of patients, were AST
elevation (72 vs 52, 78); alkaline phosphatase elevation (71 vs 64,
77); anemia (65 vs 45, 73); ALT elevation (72 vs 38, 72);
leukopenia (71 vs 15, 64); nausea and vomiting (64 vs 58, 71);
neutropenia (62 vs 18, 61); thrombocytopenia (47 vs 15, 36); pain
(10 vs 7, 42); fever (30 vs 16, 38); proteinuria (10 vs 2, 32);
constipation (10 vs 11, 31); diarrhea (24 vs 31, 30); rash (24 vs
13, 28); and bilirubin elevation (16 vs 25, 26). See complete
Warnings, Precautions, Adverse Reactions, and Dosage and
Administration sections in the accompanying full Prescribing
Information for safety and dosing guidelines. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Amy Sousa, Lilly, +1-317-276-8478, ;
or Neil Hochman, CPR Worldwide, +1-212-453-2067,
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