Clinical Data Suggest Potential Versatility Of ALIMTA-Based Regimens In Lung Cancer

showed additional utility in the treatment of the most diagnosed type of cancer , according to data presented 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® (gemcitabine HC1 for injection) plus carboplatin (ASCO Abstract # 7517 ). The study, conducted by the Norwegian Lung Cancer Group, enrolled 446 chemonaïve 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 Bjørn Henning Grønberg, 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 was presented at ASCO from a Phase II, open-label, non-randomized trial on an International Oncology Network Study evaluating the safety of a triplet therapy in which bevacizumab (Avastin®) was added to the combination of ALIMTA plus oxaliplatin (Eloxatin®) in patients with advanced NSCLC (Abstract # 7700 ). 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. , 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®), erlotinib (Tarceva®), cetuximab (Erbitux®) and vandetanib (Zactima™).

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.
source:www.medicalnewstoday.com