In a recent study, Lilly's drug AlimtaŽ (pemetrexed) demonstrated a similar patient survival rate, but with an improved safety profile, when compared to TaxotereŽ (docetaxel), the current standard of care for second-line non-small cell lung cancer.
The research findings of the largest head-to-head Phase III trial ever reported to date in second-line non-small cell lung cancer were reported in the May 1 issue of the Journal of Clinical Oncology(1), a peer-reviewed journal.
Alimta, in combination with cisplatin, was recently approved by the FDA for use in the treatment of malignant pleural mesothelioma, a cancer often associated with asbestos exposure.
Currently, Taxotere is the only drug approved in the U.S. to treat patients with non-small cell lung cancer in the second line setting. While the drug extends the average patient's life by a few months when compared to best supportive care, it is associated with several side effects, including hair loss and blood-related toxicities, including neutropenia, a lowering of the white blood cell count that can cause infections and fever, thus requiring hospitalization.
The new findings show that Alimta, which can be administered in 10 to 15 minute infusions once every three weeks, displayed a survival rate comparable to that of Taxotere (median survival was 8.3 months vs. 7.9 months respectively), but with fewer serious side effects.
"Alimta clearly had fewer drug-related hematological side effects, which resulted in fewer hospitalizations," said Nasser Hanna, M.D., lead author of the study and assistant professor, Indiana University School of Medicine and member of the Indiana University Cancer Center. "So in short, Alimta is better tolerated, it's convenient to administer and it's equally as effective as Taxotere." Patients on Alimta did show an increased transient elevation in the liver enzyme, Alanine Transaminase (ALT) said Hanna.
Lilly has submitted a New Drug Application to the Food and Drug Administration for the use of Alimta in the second-line treatment of non-small cell lung cancer. Lilly anticipates a regulatory decision by the fourth quarter. Lilly has also submitted a dual European submission, with the first part for Alimta, combined with cisplatin, in the treatment of malignant pleural mesothelioma and the second for Alimta as a single-agent in the second-line treatment of non-small cell lung cancer.