Alimta Continues To Show Versatility in Treating Different Cancers

Eli Lilly

Alimta® (pemetrexed), when combined with cisplatin, is emerging as a promising new treatment option for malignant pleural mesothelioma (MPM) as a result of a Phase III trial presented earlier this year. An investigational compound, Alimta, may also be active in treating lung cancer, according to the results of several new Phase I and II studies.

"New data continue to show that Alimta produces promising results either as a single or combination agent across tumour types," said Dr. Frances Shepherd, professor of medicine, University of Toronto, Scott Taylor Chair in Lung Cancer Research, Princess Margaret Hospital, Toronto, Ontario, Canada. "The data gathered thus far have prompted us to extend the scope of Alimta studies across cancers, regimens and drug combinations. We are very excited about the development of this drug and look forward to realizing its potential," said Shepherd, who is also president-elect of the International Association for the Study of Lung Cancer.

Alimta, when studied with both cisplatin and carboplatin, has shown promising results. In a Phase II study combining Alimta with cisplatin in patients with non-small-cell lung cancer, the combination demonstrated 8.9 months median survival and a 44.8 percent response rate.

Eli Lilly and Company sponsored new studies presented at the 27th European Society for Medical Oncology (ESMO) Congress in Nice, France, which build on these consistent results.

Study Results from Alimta/Gemzar® in NSCLC
Data were presented from a Phase II trial of Alimta combined with Gemzar® (gemcitabine HCl), in patients with advanced non-small-cell lung cancer (NSCLC). Gemzar is already a standard of care worldwide for pancreas cancer and is also the standard of care in many parts of the world for NSCLC and bladder cancers.

The platinum-free combination of Alimta and Gemzar produced a median survival of 11.3 months and a median time to progression of 4.9 months. The time to event measures were encouraging. Both drugs have produced response rates in the range of 20 percent when they have been studied as single agents. In addition, 50 percent had disease stabilization and 44 percent of the patients were alive one year after enrolling in the study.

The most common hematologic side effect was neutropenia (a decrease in white blood cells), which occurred in 34 percent of the patients. The most common nonhematologic side effect was elevated AST/ALT (aspartate amino transferase/ amino alanine transferase - enzymes monitored to assess liver function) occurring in 21 percent of patients. Patients in this study received dietary amounts of folic acid and vitamin B12 supplementation.

Investigators also gathered data on improvement or stability of disease-related symptoms, which showed improvement/stability of anorexia, cough, dyspnea (difficult, painful breathing or shortness of breath) and pain.

Overall, the study investigators concluded that Alimta/Gemzar should be studied further in advanced NSCLC based on the encouraging survival results and symptom benefits.

"The preliminary results seen in the Alimta/Gemzar study confirmed the potential strength of Alimta," said Paolo Paoletti, M.D., vice president medical - oncology, Eli Lilly and Company, "The possibility of offering a nonplatinum combination in NSCLC patients may be an important alternative for treatment of this disease, especially considering the easy-to-control toxicity profile of Alimta. We certainly look forward to examining the therapeutic profile of Alimta in upcoming studies."

A Phase III study comparing Alimta with Taxotere® (docetaxel) in second-line chemotherapy has been fully enrolled and is awaiting final analysis and dissemination of the results.

Study Results from Clinical Benefit Algorithm for Mesothelioma
Study results presented in May 2002 at the American Society of Clinical Oncology (ASCO) demonstrated that a combination of Alimta and cisplatin has high efficacy in tumour reduction and enables people with malignant pleural mesothelioma (MPM) to live longer. New data from that same study also demonstrates Alimta/cisplatin has an impact on disease-related symptoms as measured by a composite endpoint called clinical benefit response. Clinical benefit response is an objective clinical measure of symptom improvement that, in this study, was based on pain (intensity and analgesic consumption), dyspnea and performance status.

Clinical benefit parameters were rated after each three-week cycle of treatment and were compared with baseline values. A clinical benefit responder was defined as any patient who demonstrated sustained improvement after at least two cycles of treatment in at least one parameter and in absence of deterioration in any other parameter.

Of the 368 patients evaluable for clinical benefit response, 21 percent of the Alimta/cisplatin patients and 14 percent of cisplatin patients were considered responders. The Alimta/cisplatin regimen also showed a greater improvement in dyspnea (15 versus 8 patients) and pain intensity (22 versus 10 patients).

As presented at ASCO, median survival was 12.1 months for Alimta/cisplatin, versus 9.3 months for cisplatin alone, with an overall tumor response rate of 41 percent versus 17 percent with cisplatin alone. These results combined with those released today demonstrate a real advance in the treatment of this notoriously hard-to-treat cancer.

Results from Alimta/Navelbine® in a Phase I/II Trial
Preliminary data from a Phase I/II study of Alimta and Navelbine (vinorelbine) (a commonly used antineoplastic therapy) were presented today. The Phase I portion of the study established the dosing regimen. Results from the ongoing Phase II portion of this study, which has enrolled only advanced NSCLC patients with no prior chemotherapy, showed promising antitumour activity.

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