INDIANAPOLIS, June 5, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) announced today that PARAMOUNT, its Phase III study evaluating ALIMTA® (pemetrexed for injection) in the continuation maintenance setting, met its primary endpoint of progression-free survival, or the time a patient is alive without their disease worsening, for patients with a specific type of lung cancer called advanced nonsquamous non-small cell lung cancer (NSCLC).
"Continuation maintenance" treatment is when one of the same medicines used in first-line treatment setting is continued as maintenance therapy in an effort to control the cancer.
Results from the study will be presented on Sunday, June 5 at 11:30 a.m. CDT during the Lung Cancer Oral Abstract Session (Abstract #CRA7510) at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. Lilly will present overall survival results from PARAMOUNT at a medical meeting in the future.
PARAMOUNT is the second study to evaluate the use of ALIMTA as a maintenance therapy in patients with advanced nonsquamous NSCLC, and the first study to evaluate the use of continuation maintenance with ALIMTA(1) following first-line ALIMTA plus cisplatin therapy.
Results of this multicenter, double-blind trial demonstrated the median progression-free survival measured from randomization (after first-line treatment) was 3.9 months on the ALIMTA arm as compared to 2.6 months on the placebo arm with a hazard ratio of 0.64. Said another way, the study showed that ALIMTA continuation maintenance arm resulted in a 36 percent improvement of survival without disease worsening over the placebo arm. The maintenance disease control rate, or the percentage of patients achieving either a response or stable disease first measured at 6 weeks post-randomization was 71.8 percent (2.8%/69.0%) on the ALIMTA