Data published in The Lancet showed a survival benefit in nonsquamous patients with advanced non-small cell lung cancer (NSCLC) who received maintenance therapy with Alimta (pemetrexed for injection) plus best supportive care as compared to placebo plus best supportive care.

This phase-III clinical trial supported previous studies looking at the use of histology to tailor treatment with Alimta for patients with advanced nonsquamous NSCLC. Advanced nonsquamous NSCLC patients on the Alimta plus best supportive care arm achieved more than five months increased median overall survival compared to nonsquamous NSCLC patients who received placebo plus best supportive care following initial chemotherapy.

The publication of The Lancet manuscript follows the July 2009 US Food and Drug Administration (FDA) approval of Alimta as maintenance therapy for patients with locally advanced or metastatic nonsquamous NSCLC, whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Alimta is not indicated for treatment in patients with squamous cell NSCLC. The European Commission also granted a similar approval in July 2009.

NSCLC is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma - which account for about 70 per cent of all NSCLC diagnoses - as well as histologies classified as 'other'. About 30 per cent of all NSCLC cases are squamous.

Maintenance therapy is a relatively new concept in NSCLC treatment, according to study lead author Chandra P Belani, Miriam Beckner distinguished professor of medicine and deputy director of Penn State Cancer Institute at Penn State Milton S Hershey Medical Center in Hershey, Pennsylvania.

"Previously, we would treat patients with advanced non-small cell lung cancer with four cycles of a platinum-based therapy, and then wait for a recurrence before treating again," said Dr Belani. "The results of this study are provocative and introduce the concept of maintenance therapy for patients with non-small cell lung cancer."

"What makes these findings more compelling is a survival advantage exceeding five months with Alimta for patients with nonsquamous cell histologies. The degree of patient benefit is substantial," added Dr Belani.

"This study is very encouraging for our fight against this deadly disease," added Richard Gaynor, Lilly's vice president of cancer research and global oncology platform leader. "First, it makes a case for maintenance therapy in advanced, nonsquamous NSCLC. Secondly, it showcases the importance of histology in tailoring a treatment to the nonsquamous NSCLC patient."