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ALIMTA First Chemotherapy Approved in Europe as Continuation Maintenance Therapy for Most Common Form of Lung Cancer
Date:10/28/2011

lready benefited from first-line treatment will now have the option to continue treatment with ALIMTA, with the goal of a better clinical outcome."

Approval of ALIMTA continuation maintenance was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology (ASCO) Annual Meeting.(1) The study examined whether ALIMTA continuation maintenance therapy improves progression-free survival, as well as overall survival, after ALIMTA-cisplatin induction therapy in patients with advanced nonsquamous NSCLC. The study met its primary endpoint of progression-free survival, and a preliminary analysis has shown a strong trend toward positive overall survival.  

Patients received standard induction therapy with four cycles of ALIMTA (500 mg/m2) and cisplatin (75 mg/m2) on a 21-day cycle. Of the 939 patients with advanced nonsquamous NSCLC who were enrolled and received induction therapy, 539 non-progressers with a good performance status were subsequently randomized to receive one of two maintenance therapy regimens. They received either ALIMTA (500 mg/m2 on day one of a 21-day cycle) plus best supportive care (n=359), or placebo plus best supportive care (n=180) until disease progression. All patients received vitamin B12, folic acid and dexamethasone.

ALIMTA is approved in Europe and the U.S. for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

ALIMTA is also approved, in combination with cisplatin, in both the EU and U.S. for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.

Notes to Editor

About Maintenance Treatment in NSCLC

Maintenance therapy is a relativ
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SOURCE Eli Lilly and Company
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