Lilly's Almita enters Ph III trial for SCLC

US drugmaker Eli Lilly says that it has initiated a Phase III trial of its anticancer agent Alimta (pemetrexed for injection). Specifically, the drug will be used in combination with carboplatin-based chemotherapy in the treatment of extensive-stage small-cell lung cancer (SCLC), which is a rapidly spreading form of the disease.

Lilly explained that the drug is a novel antifolate that simultaneously blocks three separate enzyme targets important to the development of cancerous cells. The company added that it is already approved by the Food and Drug Administration, also in combination with cisplatin, for the treatment of patients with malignant pleural mesothelioma, and as a regimen for locally-advanced or metastatic non-small cell lung cancer (Marketletters passim).

The study, referred to as the Global Analysis of Pemetrexed in SCLC Extensive Stage (GALES), will compare the combined regimen with that of etoposide plus carboplatin, the current standard treatment approach. Key efficacy indicators will include assessment of the level of overall survival that Alimta plus carboplatin confers, as well as the pharmacogenetic analysis of patient-authorized tissue and blood samples. The firm went on to say that, through its use of pharmacogenomics, it hopes to identify patient subgroups which derive most benefit from Alimata-based therapy.