Final results from PARAMOUNT, a Phase III study of ALIMTA® (pemetrexed for injection) in the continuation maintenance setting, demonstrated improved overall survival in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) treated with ALIMTA continuation maintenance, according to data announced today by Eli Lilly and Company (NYSE: LLY). PARAMOUNT results will be presented on Monday, June 4, at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill.
Representing a paradigm shift in the treatment of lung cancer, "continuation maintenance" treatment is when one of the same medicines used in the first-line treatment setting is continued as maintenance therapy in an ongoing effort to control the cancer. Prior to the use of maintenance treatment, physicians typically treated a patient with four to six cycles of chemotherapy and then waited until the disease returned or worsened before treating it again. In PARAMOUNT, ALIMTA was prescribed in combination with cisplatin induction therapy immediately followed by maintenance ALIMTA and best supportive care.
PARAMOUNT builds upon previous studies evaluating the use of ALIMTA as a first-line therapy with cisplatin, as well as ALIMTA as a maintenance therapy (following non-ALIMTA first-line agents) in patients with advanced nonsquamous NSCLC. However, PARAMOUNT is the first study that evaluated both the use of ALIMTA plus cisplatin therapy followed immediately by the use of ALIMTA in the continuation maintenance setting. At ASCO 2011, the primary progression-free survival results of PARAMOUNT were presented and showed that ALIMTA continuation maintenance improved progression-free survival, or the time a patient is alive without their disease worsening.
Final results of this multicenter, double-blind, placebo-controlled trial demonstrated a statistically significant 22 percent reduction in the risk of death (HR=0.78). Patients achieved a median overall survival of 13.9 months from randomization (16.9 months from start of induction) on the ALIMTA continuation maintenance arm compared to 11.0 months from randomization (14.0 months from start of induction) on the placebo arm.
"The ALIMTA PARAMOUNT study is the first to show a survival benefit in continuation maintenance – answering an important question for physicians treating patients with this type of lung cancer," said Allen S. Melemed, M.D., M.B.A., a senior medical director with Lilly Oncology.