Lilly Announces PRONOUNCE Trial Did Not Meet Primary Superiority Endpoint
Eli Lilly and Company (NYSE: LLY)
announced results from its PRONOUNCE trial of ALIMTA® (pemetrexed for
injection) for treatment of nonsquamous non-small cell lung cancer (NSCLC)
that was presented today at the American Society of Clinical Oncology (ASCO)
annual meeting in Chicago, Ill.
The PRONOUNCE trial compared an ALIMTA (pemetrexed), carboplatin doublet
regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen.
The study did not achieve its primary superiority endpoint of improved
progression-free survival without grade four adverse events (G4PFS). No
significant difference was observed between the treatment arms for secondary
endpoints of progression-free survival (PFS), overall survival, overall
response rate and disease control rate. Toxicity profiles observed in the
trial were consistent with the known safety profiles of each therapy.
"The history of ALIMTA clinical evaluation from histology to its use in the
maintenance therapy paradigm encourages us to explore new avenues to
determine if we can improve patient outcomes," said Richard Gaynor, M.D., vice
president of product development and medical affairs for Lilly Oncology.
"These data give us additional insights that further inform the vast body of
ALIMTA clinical data."
The safety and efficacy profile for ALIMTA has been the subject of
Lilly-sponsored studies involving an estimated 32,500 patients over the span
of almost 20 years.
(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.