CHICAGO, June 2 /PRNewswire/ --
-- Study Highlights Quality-of-Life Data
ALIMTA(R) (pemetrexed for injection) showed additional utility in the treatment of the most diagnosed type of cancer(i), according to data presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO). Results from a Phase III study suggest that a first-line ALIMTA-based regimen may deliver less toxicity than a commonly used therapy in advanced non-small cell lung cancer (NSCLC). ALIMTA is manufactured and marketed by Eli Lilly and Company.
A prospective, randomized, multicenter Phase III study was conducted to compare ALIMTA plus carboplatin with the commonly used regimen of GEMZAR(R) (gemcitabine HC1 for injection) plus carboplatin (ASCO Abstract # 7517(ii)). The study, conducted by the Norwegian Lung Cancer Group, enrolled 446 chemonaive patients with either stage IIIB or IV NSCLC. The primary purpose of the study was to evaluate if the ALIMTA-carboplatin combination provided increased quality-of-life benefits while offering comparable survival data. As such, the primary endpoint was quality of life (defined in the study as nausea/vomiting; dyspnea or a difficulty in breathing, and; fatigue) and the secondary endpoint was overall survival.
Thus far, 384 patients have been analyzed for toxicity and there were fewer patients in the ALIMTA arm who experienced Grade 3/4 thrombocytopenia or a low platelet level (48 vs. 107, p < .001); leukopenia or a lowering of leukocyte white blood cells (44 vs. 89, p < .001), and; granulocytopenia or a lowering of granulocyte white blood cells (78 vs. 98, p=.02). More patients in the GEMZAR arm received transfusion of platelets (5 vs. 19, p=.02). At this point, no difference in survival has been observed.
"The patients in this study received a comparable quality-of-life benefit whether they received ALIMTA and carboplatin or GEMZAR and carboplatin," said Bjorn Henning Gronberg, M.D. of St. Olavs University Hospital in Norway and the study's principal investigator. "Patients on the ALIMTA arm also appeared to benefit from a lower toxicity profile."
Additional data to be presented on Sunday, June 3rd at ASCO from a Phase II, open-label, non-randomized trial will report on an International Oncology Network Study evaluating the safety of a triplet therapy in which bevacizumab (Avastin(R)) was added to the combination of ALIMTA plus oxaliplatin (Eloxatin(R)) in patients with advanced NSCLC (Abstract # 7700(iii)). Previous research has indicated that oxaliplatin and ALIMTA, as single agents, have shown activity in NSCLC, and ALIMTA has shown synergistic effects when combined with platinum-based drugs.(iv,v) This preliminary study was conducted to evaluate the efficacy and safety of the combination as first-line treatment for NSCLC.
"We are pleased to see that ALIMTA has a synergistic effect with platinum agents like carboplatin," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly. "We look forward to continued research on ALIMTA as a chemotherapeutic foundation with targeted therapies and other anti-cancer agents for the treatment of lung cancer.
"Lilly is aggressively investigating potential novel therapies in other tumor types, as we are committed to providing patients with therapeutic options that fight the cancer but do not compromise quality of life."
Lilly also has studied ALIMTA plus cisplatin for the first-line treatment of NSCLC. In the first quarter of 2007, a study of ALIMTA plus cisplatin versus GEMZAR plus cisplatin met its primary endpoint of non-inferiority relative to overall survival. Utilizing these data, Lilly plans to submit ALIMTA for an indication for the first-line treatment of NSCLC to the European Medicines Agency (EMEA) later this year.
At ASCO, researchers will also present data that show ALIMTA as a chemotherapeutic foundation to a variety of approved and investigational targeted anti-cancer agents, including bevacizumab (Avastin(R)), erlotinib (Tarceva(R)), cetuximab (Erbitux(R)) and vandetanib (Zactima(TM)).
ALIMTA is an antifolate which interferes with a crucial process that allows cancer cells to reproduce and spread. The most common side effects when ALIMTA is used as monotherapy are disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash and desquamation or flaking of skin in scales. Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.
About Non-Small Cell Lung Cancer
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.
ALIMTA
Indications
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 < 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 1500 cells/mm3, the platelet count is > 100,000 cells/mm3 and creatinine clearance 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.
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