ELI LILLY LAUNCHES TRIAL OF ALIMTA IN SMALL-CELL LUNG CANCER

Eli Lilly has launched a major clinical trial evaluating Alimta (pemetrexed for injection) in extensive-stage small-cell lung cancer (SCLC), a devastating and rapidly spreading form of lung cancer. This international trial, expected to be the largest ever to be conducted in SCLC, will assess the potential clinical benefit of pemetrexed in combination with carboplatin, a commonly used chemotherapeutic agent, in direct comparison to the current leading treatment option of etoposide in combination with carboplatin.

The trial -- known as GALES -- is a Phase III, global, multicenter, randomized, open-label study that will enroll approximately 1,820 patients with extensive-stage SCLC. The study's primary objective is to compare the overall survival after treatment with pemetrexed plus carboplatin versus etoposide plus carboplatin in previously untreated patients.

Specifically, the study will use pharmacogenomic analysis of patient-authorized tissue and blood samples to determine if there are any biological characteristics that would indicate a potentially higher clinical benefit from the Alimta therapy for any patient subpopulation groups. Pharmacogenomics may help researchers find ways to tailor chemotherapy to patients based on their biological indication to benefit from specific treatments.

Alimta is a novel antifolate that simultaneously blocks three separate enzyme targets important to the formation of basic building blocks by which cancer cells grow and divide. It is currently approved, in combination with cisplatin, for the treatment of patients with malignant pleural mesothelioma whose disease is unrectable or who are otherwise not candidates for curative surgery.