SEOUL--4 Sep--PRNewswire-AsiaNet/InfoQuest
The clinical benefit of ALIMTA(R) (pemetrexed for injection) continues to be validated across patient populations, as demonstrated in two studies conducted in Asia. The data presented today at the 12th World Conference on Lung Cancer provide further support of the efficacy of Eli Lilly and Company's ALIMTA in treating non-small cell lung cancer (NSCLC), the world's most common form of cancer.(1) ALIMTA is currently indicated for the second-line treatment of non small cell lung cancer in more than 85 countries.
In one study (WCLC Abstract # P2-274), a Japanese multicenter, randomized Phase II trial, pretreated patients with locally advanced or metastatic NSCLC demonstrated more than 12 months of median survival time when treated with ALIMTA.
"This is data showing that ALIMTA not only provides excellent outcomes but also a favorable quality of life in pretreated patients with non-small cell lung cancer," said Dr. Kaoru Kubota, M.D., of the National Cancer Center Hospital East in Kashiwa, Japan and the study's principal investigator. "Other Western studies have demonstrated similar efficacy of ALIMTA in patients with
non-small cell lung cancer. It is nice to see clinical benefits substantiated in Japanese patients and observe consistency in the drug's performance."
The study evaluated 216 patients, comparing the current approved dose of ALIMTA 500 mg/m2 to ALIMTA 1000 mg/m2. Patients in the 500 mg/m2 arm showed a median survival time of 16 months compared to 12.6 months for patients in the
1000 mg/m2 arm. The study also showed one-year survival rates of 59.2 percent and 53.7 percent, and response rates of 18.5 percent and 14.8 percent, respectively. The study also provides supporting information for oncologists, affirming the currently approved dose of ALIMTA as the proper dosage for use in the second-line treatment of NSCLC.
Additionally, a randomized Phase II Taiwanese study (WCLC Abstract # P2-245) showed a median survival time of 9.1 months in patients with NSCLC who were treated either in the second- or third-line setting. The study involved 44 patients who had failed previous treatment with platinum-based chemotherapies with/without tyrosine-kinase treatment. An overall response rate of 18.2
percent was achieved with a response rate of 40 percent in patients treated in second-line compared to 11.8 percent in third-line or later treatment patients. The study also found that treatment toxicities tended to be generally mild. Grade 3/4 hematological toxicities included neutropenia in 18.2 percent, thrombocytopenia in 6.8 percent and anemia in 4.5 percent. Non-hematological
toxicities were all less than grade 3.
Three additional studies (WCLC Abstract # P2-226, WCLC Abstract # P2-237, WCLC Abstract # P2-243) being presented at WCLC also provided further affirming evidence of the efficacy of ALIMTA in the second-line treatment of NSCLC.
"We have always been impressed with ALIMTA for its consistent performance and versatility," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly. "These studies underline the efficacy of ALIMTA in the second-line treatment of non-small cell lung cancer. As Lilly looks to potentially bring ALIMTA to market in countries throughout
Asia, it is important that ALIMTA demonstrates efficacy and safety across diverse patient populations."
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 second-line treatment of NSCLC.
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.
(1) Parkin DM, Bray F, Ferlay J, Pisani P, Global Cancer Statistics, 2002.
CA Cancer J Clin 2005;55;74-108,
http://intl-caonline.amcancersoc.org/cgi/content/abstract/55/2/74,
(April 10, 2007).
ALIMTA ABBREVIATED PRESCRIBING INFORMATION
Uses
ALIMTA is indicated in combination with cisplatin for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. ALIMTA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, after prior chemotherapy.
Dosage and Administration
The drug is to be administered intravenously, under the supervision of a physician qualified in the use of cytotoxic anti-cancer therapy.
Malignant pleural mesothelioma: Pemetrexed in combination with cisplatin has been investigated using a three-week (21-day) cycle. Pemetrexed is used at 500mg/m2 of body surface area (BSA), given by ten-minute infusion, on day 1 of each 21-day cycle. Cisplatin is used at 75mg/m2 BSA, given by two-hour infusion, approximately 30 minutes after completion of the pemetrexed infusion
on day 1 of each cycle. Adequate anti-emetic treatment and hydration for cisplatin treatment must be given.
Non-small cell lung cancer: The recommended dose of pemetrexed is 500mg/m2 BSA, given by ten-minute infusion, on day 1 of each 21-day cycle.
Pre-medication: Supplement with 1000 micrograms intramuscular vitamin B12 and oral folic acid (350 to 1000 micrograms) to reduce toxicity (for full details see Summary of Product Characteristics [SPC
]). To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration - this should be
equivalent to 4mg of dexamethasone administered orally twice a day.
Monitoring: Monitor prior to each dose for complete blood cell count, including a differential white cell count and platelet count. Absolute neutrophil count should be greater than or equal to 1,500 cells/mm3 and platelets greater than or equal to 100,000 cells/mm3. Prior to each dose, collect blood chemistry tests to evaluate renal and hepatic function. Dose adjustments to pemetrexed and/or cisplatin at the start of a subsequent cycle should be based on nadir haematological counts or maximum non-haematological
toxicity. If necessary, delay or withhold treatment in the presence of haematological toxicity, neurotoxicity, and/or impaired hepatic/renal function. (For full information on dose modification see SPC.)
Children and adolescents: Not recommended for use in patients under 18 years of age.
Renal impairment: Patients with creatinine clearance greater than or equal to 45ml/min require no dose adjustment other than those recommended for all patients. Use in patients with creatinine clearance below 45ml/min is not recommended. See also Warnings and Special Precautions.
Hepatic impairment: Patients with hepatic impairment, such as bilirubin >1.5-times the upper limit of normal and/or transaminase >3.0-times the upper limit of normal (hepatic metastases absent) or >5.0-times the upper limit of normal (hepatic metastases present), have not been specifically studied.
Contra-indications
Hypersensitivity to pemetrexed or to any of the excipients. Concomitant yellow fever vaccine. Breast-feeding.
Warnings and Special Precautions
Myelosuppression is usually the dose-limiting toxicity. Patients must be instructed to take folic acid and vitamin B12 as a prophylactic measure. Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions. Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in combination with other
chemotherapeutic agents. Many of the patients in whom these occurred had underlying risk factors including dehydration or pre-existing hypertension or diabetes. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to administration. Serious cardiovascular events, including myocardial infarction and cerebrovascular events, have been uncommonly reported when pemetrexed is given in combination with other cytotoxic agents; most of these patients had
pre-existing cardiovascular risk. Concomitant use of live attenuated vaccines is not recommended.
Interactions
Concomitant administration of nephrotoxic drugs and substances that are also tubularly secreted could potentially result in delayed clearance of pemetrexed. If necessary, creatinine clearance should be closely monitored. Patients must avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) with long elimination half-lives for at least 5 days prior to, on the day, and at
least 2 days following pemetrexed administration. In patients with normal renal function (creatinine clearance greater than or equal to 80ml/min), high doses of NSAIDs (such as ibuprofen >1600mg/day) and aspirin at higher dosage (greater than or equal to 1.3g daily) may decrease pemetrexed elimination and increase the occurrence of adverse events. Patients with mild to moderate renal
insufficiency (creatinine clearance from 49 to 79ml/min) should avoid taking NSAIDs (e.g., ibuprofen) or aspirin at higher dosage, for 2 days before, on the day of, and 2 days following pemetrexed administration.
There is a possible interaction between oral anticoagulants and pemetrexed; therefore, increase the frequency of International Normalised Ratio monitoring (INR) if treating with oral anticoagulants.
Pregnancy and Lactation
Avoid in pregnancy and do not use in breast-feeding women.
Pemetrexed can be genotoxic; sexually mature males are advised not to father a child during treatment and up to 6 months thereafter. Owing to the possibility of irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment. Women of childbearing potential must use effective contraception during treatment.
Driving, etc
It has been reported that pemetrexed can cause somnolence. Patients should be cautioned against driving or operating machinery.
Undesirable Effects
Haematological: Very common: Anaemia, leucopenia, thrombocytopenia,neutropenia. Common: Febrile neutropenia and infection without neutropenia. Uncommon: Pancytopenia.
Gastro-intestinal: Very common: Nausea, vomiting, stomatitis/pharyngitis, anorexia, diarrhoea, constipation. Common: Dyspepsia, abdominal pain. Rare: Colitis.
General: Very common: Fatigue. Common: Fever, conjunctivitis.
Metabolism and nutrition: Common: Dehydration.
Nervous system: Very common: Neuropathy - sensory. Common: Neuropathy - motor, dysgeusia.
Renal and urinary: Very common: Creatinine elevation, creatinine clearance decreased. Common: Renal failure.
Hepatobiliary: Common: SGPT (ALT) elevation and SGOT (AST) elevation, increased GGT. Rare: Cases of hepatitis, potentially serious, have been reported during trials.
Skin and subcutaneous tissue: Very common: Rash/desquamation, alopecia. Common: Urticaria, allergic action/hypersensitivity, erythema multiforme, pruritus.
Cardiovascular and cerebrovascular: Uncommon: Myocardial infarction, angina pectoris, cerebrovascular accident, arrhythmias, transient ischaemic attack. (Usually when given in combination with other cytotoxic agents and with re-existing cardiovascular risk.) Common: Chest pain.
For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at http://emc.medicines.org.uk
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.
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
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 products 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.
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SOURCE: Eli Lilly and Company
CONTACT: Gregory L. Clarke,
Lilly,
+1-317-554-7119 (mobile),
[email protected]; or
Chantal Samonte,
CPR Worldwide,
+1-202-550-4129 (mobile),
[email protected]
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--Distributed by AsiaNet ( www.asianetnews.net )--