INDIANAPOLIS - Eli Lilly and Co.'s chemotherapy drug Alimta continues to show signs as a promising new treatment option for malignant pleural mesothelioma and non-small cell lung cancer, according to data presented recently at a conference in France.

In several new studies with Alimta (pemetraexed), researchers discovered an increased median survival and response rate for patients with mesothelioma and lung cancer. The data from the studies was presented at the 27th European Society for Medical Oncology Congress, held Oct. 18 to 22 in Nice, France.

"New data continues to show that Alimta produces promising results either as a single or combination agent across tumor types," said Dr. Francis Shepard, professor of medicine at the University of Toronto and one of the researchers involved in the study. "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."

PHASE III TRIALS

In Phase III trials for patients with mesothelioma, data from patients who were administered a combination of Alimta and cisplatin showed high efficacy in tumor reproduction and a longer life span. The new data demonstrates that 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 particular study, was based on pain, dyspnea and performance status.

At the end of each three-week cycle of the study, clinical benefit parameters were rated and 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 evaluated, 21 percent of the Alimta/cisplatin patients and 14 percent of cisplatin patients were considered responders. The Alimta/cisplatin treatment also showed a greater improvement in dyspnea, 15 versus eight patients, and pain intensity, 22 versus 10 patients.

ALIMTA/GEMZAR

The recent studies also show that in Phase I and II trials of non-small cell lung cancer patients given a combination of Alimta with another Eli Lilly drug, Gemzar (gemcitabine HCI), the patients demonstrated a 8.9-month median survival and a 44.8 percent response rate. The researchers plan to continue studies in the lung cancer patients and also plan to make other combinations with Alimta to discover the "therapeutic profile" of Alimta in upcoming studies.

Alimta initially gained attention in fall 2000 as researchers from the Newcastle Freeman Hospital in Glasgow, Scotland, hailed the drug as a breakthrough in treating mesothelioma and reported that a majority of patients given the drug suffer no further cancerous growth and enjoy a rapid improvement of their symptoms. The drug was given to 27 patients at the hospital, most of them former construction workers. Doctors reported that 25 of the patients tested suffered no further growth of the cancerous cells.

On July 9, Eli Lilly and the U.S. Food and Drug Administration announced an agreement to fast-track Alimta and make it available to those patients currently suffering from malignant pleural mesothelioma.

SOURCE: Mealey's Litigation Report Volume 17, Issue #19