Eli Lilly Launches Phase III Alimta Trials

October 20, 2006 - According to a press release issued by Eli Lilly and Company pharmaceuticals, their Phase III trials for the cancer-fighting drug Alimta have begun.  This international trial, expected to be the largest ever to be conducted in small-cell lung cancer (SCLC), “will assess the potential clinical benefit of pemetrexed in combination with carboplatin, a commonly-used chemotherapeutic agent, in direct comparison to the current leading treatment option of etoposide in combination with carboplatin.”

The study will involve 1,820 people with extensive-stage small cell lung cancer.  The overall survival rate after treatment (in previously untreated patients) will be the focus of the study, headed by British cancer specialist Nick Thatcher, M.D. of Christie Hospital NHS Trust in Manchester, United Kingdom.

SCLC accounts for 15% to 20% of all lung cancers, notes the press release.  SCLC spreads very quickly and is often not diagnosed until the later stages of the disease, leaving victims with few options.  Surgery to remove the cancer is generally not one of those options.

"An innovative aspect of this study is that we will employ the use of pharmacogenomic analysis to assess potential biological characteristics relative to a patient's potential response to chemotherapy," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Eli Lilly and Company.

Researchers add that they may one day find ways to "tailor" chemotherapy to patients based on their biological indication to benefit from specific treatments.

Results of Eli Lilly’s Phase II Alimta trials were recently published in the October 2006 issue of The Journal of Clinical Oncology.