Drug maker Eli Lilly and Co. (LLY) announced Monday that study of Alimta or pemetrexed for injection for treatment of non-squamous non-small cell lung cancer or NSCLC failed to achieve primary superiority endpoint.
According to the company, the Pronounce study did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events or G4PFS. 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 about 20 years.
The study revealed no significant difference between the treatment arms for secondary endpoints of progression-free survival or PFS overall survival, overall response rate and disease control rate. Toxicity profiles observed were consistent with the known safety profiles of each therapy.
The Pronounce trial compared Alimta, carboplatin doublet regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen.
Pronounce is a randomized, open-label Phase III superiority study of first-line chemotherapy pemetrexed plus carboplatin, followed by maintenance pemetrexed, compared to paclitaxel plus carboplatin plus bevacizumab, followed by maintenance bevacizumab in patients with advanced non-squamous NSCLC conducted in the U.S.
Eli Lilly noted that the results from the Pronounce trial of Alimta for treatment of NSCLC was presented on Monday at the American Society of Clinical Oncology annual meeting in Chicago, Ill.
"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, vice president of product development and medical affairs for Lilly Oncology.
LLY is currently trading at $52.74, down 0.78 percent, on the NYSE.
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