BN003644 15 de maio de 2008 21:00 HORALOCAL
INDIANAPOLIS, May 15 /PRNewswire-FirstCall/ -- Lung cancer
patients whose histology is factored into treatment decisions may
fare better as a result, according to data from a pivotal non-small
cell lung cancer (NSCLC) clinical trial. Data from the trial, which
involved Eli Lilly and Company's ALIMTA(R) (pemetrexed for
injection), will be presented at the 44th Annual Meeting of the
American Society of Clinical Oncology (ASCO) in Chicago, Ill., May 30
-- June 3, 2008.
"The data presented at ASCO confirms that histology matters when
treating non-small cell lung cancer," said Richard Gaynor, M.D., vice
president, cancer research and global oncology platform leader for
Lilly. "We are seeing continued affirmation that when physicians
factor in a patient's histology, pemetrexed becomes an even more
valuable treatment option in non-small cell lung cancer."
Results from a multicenter, double-blind Phase III trial will be
presented on June 2, 2008, at ASCO (Abstract # 8011). The study also
was one of those featured during ASCO's live online presscast, a
virtual press event that marked the first time researchers were
invited to present key abstracts to the media prior to the annual
meeting.
The trial compared the efficacy and safety of pemetrexed versus a
placebo in 663 patients with stage IIIB/IV NSCLC whose disease had
not progressed after four cycles of platinum-based induction
chemotherapy. According to the results, patients treated with
pemetrexed demonstrated increased efficacy with respect to
progression-free survival compared to those treated by placebo (4.3
months vs. 2.6 months), and pemetrexed patients also achieved better
tumor response (p < 0.001).
However, when data was broken down by histology, it was comparable to
previous pemetrexed trials evaluating histology -- patients with a
non-squamous histology fared better than those with a squamous
histology. Patients with non-squamous histology who were treated
with pemetrexed achieved 4.5 months of median progression-free
survival compared to 2.8 months for patients with squamous histology.
"The efficacy findings of this data show that pemetrexed performed
better in patients with non-squamous histology for the treatment of
non-small cell lung cancer," said the trial's lead investigator,
Tudor Ciuleanu, M.D. of the Institutul Oncologi I Chiricuta in Cluj,
Romania.
Patients in the trial were treated with pemetrexed (500 mg/m2) plus
best supportive care or placebo plus best supportive care. All
patients were supplemented with vitamin B12, folic acid and
dexamethasone.
No significant toxicity differences were identified between the two
trial arms with the exception of grade 3/4 anemia (pemetrexed 4.5%,
placebo 1.4%) and total serious adverse events due to the treatment
(pemetrexed 4.3%, placebo 0%).
The data presented at ASCO reaffirmed findings from previous studies,
most notably a Phase III study of pemetrexed plus cisplatin versus
gemcitabine plus cisplatin in chemonaive patients with locally
advanced or metastatic NSCLC. That study showed NSCLC patients with
a non-squamous histology (those with adenocarcinoma or large cell
carcinoma) demonstrated increased benefits when treated with
pemetrexed(1).
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(2). NSCLC has five-tier staging, starting
at 0 and rising to the severity of stage IV(3). 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(4).
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(5).
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology 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. Our
quest is to develop a broad portfolio of tailored therapies that
accelerate the pace and progress of cancer care.
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.
ALIMTA(R) (pemetrexed for injection), Lilly
P-LLY
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.
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 < 45 mL/min. One patient with severe renal impairment
(creatinine clearance 19 mL/min) who did not receive folic acid and
vitamin B12 died of drug-related toxicity following administration of
ALIMTA alone.
ALIMTA can suppress bone marrow function, as manifested by
neutropenia, thrombocytopenia, and anemia (or pancytopenia).
Patients must be instructed to take folic acid and vitamin B12 with
ALIMTA as a prophylaxis to reduce treatment-related hematologic and
GI toxicities.
Pregnancy Category D-ALIMTA may cause fetal harm when administered to
a pregnant woman.
Precautions
Complete blood cell counts, including platelet counts and periodic
chemistry tests, should be performed on all patients receiving
ALIMTA.
Patients should not begin a new cycle of treatment unless the
ANC is greater than or equal to 1500 cells/mm3 and the platelet count
is greater than or equal to 100,000 cells/mm3 and creatinine
clearance is greater than or equal to 45 mL/min.
Pretreatment with dexamethasone or its equivalent has been reported
to reduce the incidence and severity of skin rash.
The effect of third space fluid, such as pleural effusion and
ascites, on ALIMTA is unknown.
In patients with clinically significant third space fluid,
consideration should be given to draining the effusion prior to
ALIMTA administration.
Concomitant administration of nephrotoxic drugs or substances that
are tubularly secreted could result in delayed clearance of ALIMTA.
Caution should be used when administering ibuprofen concurrently with
ALIMTA to patients with mild to moderate renal insufficiency
(creatinine clearance from 45 to 79 mL/min). Patients with mild to
moderate renal insufficiency should avoid taking NSAIDs with short
elimination half-lives for a period of 2 days before, the day of, and
2 days following administration of ALIMTA. In the absence of data
regarding potential interaction between ALIMTA and NSAIDs with longer
half-lives, all patients taking these NSAIDs should interrupt dosing
for at least 5 days before, the day of, and 2 days following ALIMTA
administration. If concomitant administration of an NSAID is
necessary, patients should be monitored closely for toxicity,
especially myelosuppression, renal and gastrointestinal toxicities.
It is recommended that nursing be discontinued if the mother is being
treated with ALIMTA.
ALIMTA should be administered under the supervision of a qualified
physician experienced in the use of antineoplastic agents.
Dose adjustments may be necessary in patients with hepatic
insufficiency.
Dosing and Modification Guidelines
Dose adjustments at the start of a subsequent cycle should be based
on nadir hematologic counts or maximum nonhematologic toxicity from
the preceding cycle of therapy. Modify or suspend therapy according to
the Dosage Reduction Guidelines in the full Prescribing Information.
Abbreviated Adverse Events (% incidence)
The most common adverse events (grades 3/4) with ALIMTA versus
docetaxel, respectively, for the treatment of patients with NSCLC
were anemia (8 vs 7); leukopenia (5 vs 28); neutropenia (5 vs 40);
thrombocytopenia (2 vs 1); ALT elevation (3 vs 1); febrile
neutropenia (2 vs 13); infection without neutropenia (6 vs 4);
infection/febrile neutropenia -- other (2 vs 1); fatigue (16 vs 17);
thrombosis/embolism (3 vs 3); cardiac ischemia (3 vs 1); anorexia (5
vs 8); dyspnea (18 vs 26); and chest pain (7 vs 8). The most common
clinically relevant adverse events (all grades) with ALIMTA versus
docetaxel, respectively, were fatigue (87 vs 81); anorexia (62 vs
58); nausea (39 vs 25); constipation (30 vs 23); vomiting (25 vs 19);
diarrhea (21 vs 34); stomatitis/pharyngitis (20 vs 23); edema (19 vs
24); dyspnea (72 vs 74); chest pain (38 vs 32); neuropathy/sensory
(29 vs 32); infection without neutropenia (23 vs 17); anemia (33 vs
33); fever (26 vs 19); and rash (17 vs 9).
The most common adverse events (grades 3/4) with ALIMTA in
combination with cisplatin versus cisplatin alone, respectively, for
the treatment of patients with MPM were neutropenia (24 vs 4);
leukopenia (16 vs 1); anemia (6 vs 0); thrombocytopenia (5 vs 0);
infection without neutropenia (2 vs 0); infection with grade 3/4
neutropenia (1 vs 0); infection/febrile neutropenia
-- other (1 vs 0); febrile neutropenia (1 vs 0); fatigue (17 vs 13);
thrombosis/embolism (6 vs 4); nausea (12 vs 6); vomiting (11 vs 5);
dyspnea (11 vs 7); and chest pain (9 vs 6). The most common
clinically relevant adverse events (all grades) with ALIMTA in
combination with cisplatin versus cisplatin alone, respectively, were
neutropenia (58 vs 16); leukopenia (55 vs 20); anemia (33 vs 14);
thrombocytopenia (27 vs 10); fatigue (80 vs 74); thrombosis/embolism
(7 vs 4); nausea (84 vs 79); vomiting (58 vs 52); constipation (44 vs
39); anorexia (35 vs 25); stomatitis/pharyngitis (28 vs 9); diarrhea
(26 vs 16); dyspnea (66 vs 62); chest pain (40 vs 30); and rash (22
vs 9).
See complete Warnings, Precautions, Adverse Reactions, and Dosage and
Administration sections in the full Prescribing Information for
safety and dosing guidelines.
(1) 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.
(2) 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).
(3) American Cancer Society, "How Is Non-Small Cell Lung Cancer
Staged?" October 15, 2007, American Cancer Society,
www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Small_Cell_Lung_Cancer_Staged.asp?rnav=cri
, (February 21, 2008).
(4) 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 .
(5) National Cancer Institute, "Non-Small Cell Lung Cancer Treatment
(PDQ(R)) Health Professional Version," December 14, 2007, National
Cancer Institute,
www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/HealthProfessional/page2
, (February 14, 2008).
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
05/15/2008
CONTACT: Amy Sousa of Eli Lilly and Company, office,
+1-317-276-8478, mobile, +1-317-997-1481, sousa_amy_e@lilly.com; or
Neil Hochman of CPR Worldwide, office, +1-212-453-2067, or mobile,
+1-516-784-9089, n.hochman@cprworldwideusa.com
First Call Analyst:
FCMN Contact: mark.taylor@lilly.com
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