Histology Important in Treatment of Non-Small Cell Lung Cancer With ALIMTA

Lung cancer patients whose histology is factored into treatment decisions may fare better as a result, according to data from a pivotal non-small cell lung cancer (NSCLC) clinical trial. Data from the trial, which involved Eli Lilly and Company's ALIMTA (pemetrexed for injection), will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill., May 30 -- June 3, 2008.

"The data presented at ASCO confirms that histology matters when treating non-small cell lung cancer," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly. "We are seeing continued affirmation that when physicians factor in a patient's histology, pemetrexed becomes an even more valuable treatment option in non-small cell lung cancer."

Results from a multicenter, double-blind Phase III trial will be presented on June 2, 2008, at ASCO (Abstract # 8011). The study also was one of those featured during ASCO's live online presscast, a virtual press event that marked the first time researchers were invited to present key abstracts to the media prior to the annual meeting.

The trial compared the efficacy and safety of pemetrexed versus a placebo in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy. According to the results, patients treated with pemetrexed demonstrated increased efficacy with respect to progression-free survival compared to those treated by placebo (4.3 months vs. 2.6 months), and pemetrexed patients also achieved better tumor response (p < 0.001).

However, when data was broken down by histology, it was comparable to previous pemetrexed trials evaluating histology -- patients with a non-squamous histology fared better than those with a squamous histology. Patients with non-squamous histology who were treated with pemetrexed achieved 4.5 months of median progression-free survival compared to 2.8 months for patients with squamous histology.

"The efficacy findings of this data show that pemetrexed performed better in patients with non-squamous histology for the treatment of non-small cell lung cancer," said the trial's lead investigator, Tudor Ciuleanu, M.D. of the Institutul Oncologi I Chiricuta in Cluj, Romania.

Patients in the trial were treated with pemetrexed (500 mg/m2) plus best supportive care or placebo plus best supportive care. All patients were supplemented with vitamin B12, folic acid and dexamethasone.

No significant toxicity differences were identified between the two trial arms with the exception of grade 3/4 anemia (pemetrexed 4.5%, placebo 1.4%) and total serious adverse events due to the treatment (pemetrexed 4.3%, placebo 0%).

The data presented at ASCO reaffirmed findings from previous studies, most notably a Phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic NSCLC. That study showed NSCLC patients with a non-squamous histology (those with adenocarcinoma or large cell carcinoma) demonstrated increased benefits when treated with pemetrexed.