Eli Lilly releases positive data on Alimta for lung cancer, gene expression patterns

By Elaine Rigoli

Tampa, Fla., June 5 - Eli Lilly and Co. presented data Monday affirming that Alimta (pemetrexed) offers patients with advanced non-small cell lung cancer (NSCLC) similar overall survival as docetaxel (Taxotere).

The survival data were part of a large, randomized phase 3 study to evaluate the efficacy and safety profile of Alimta as second-line therapy in NSCLC.

First reported in 2003, the study found that patients in the Alimta arm achieved 8.3 months of median survival, whereas those in the docetaxel arm obtained 7.9 months.

This updated analysis of data tracked patients from the same study nearly two years beyond the conclusion of the original study and found similar results.

The updated data showed that patients who received Alimta experienced 8.3 months of median survival compared to 8.0 months for those in the docetaxel arm, according to a news release.

The company also unveiled two breast cancer studies involving pharmacogenomics, or the study of gene expression patterns, and its chemotherapies Gemzar (gemcitabine HCl) and Alimta.

Of the approximately 90 women receiving pre-surgical chemotherapy, researchers sought to identify gene expression profiles/biomarkers that predict patients' response to chemotherapy. They also tried to determine whether these biomarkers were drug-specific.

Scientists evaluated two groups of locally advanced breast cancer patients receiving chemotherapy. DNA microarray analysis was performed on pre-treatment core biopsies from the patients.

They then treated the first group of patients (L9819) with four cycles of doxorubicin + cyclophospharmide (AC), followed by four cycles of paclitaxel (Taxol) or paclitaxel + trastuzumab (Herceptin).

The second group of patients (S329) received four cycles of Gemzar + doxorubicin followed by four cycles of Gemzar + cisplatin.

Successful microarrays were obtained on 45 of the L9819 group and 46 of the S329 group, and separate analyses on each dataset identified gene expression patterns that predicted with 75% to 80% accuracy clinical response on those patients that completed all eight cycles of chemotherapy, the release said.

Eli Lilly said comparisons of both L9819 and S329 predictors indicated that the study may provide the means to predict response related to both general and drug-specific chemotherapy, in this case Gemzar.

Indianapolis-based Eli Lilly is a global pharmaceutical developer.

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