Lilly announced that patients may receive Alimta (pemetrexed for injection) as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous non-small cell lung cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients.
Appropriate patients can now start with Alimta plus cisplatin and continue with Alimta in the maintenance setting in advanced or metastatic NS NSCLC. Alimta is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
The FDA approval was based on results from PARAMOUNT, a global, multicenter, double-blind Phase 3 trial. A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study and received Alimta (500mg/m2 on day one of a 21-day cycle) in combination with cisplatin (75mg/m2) induction therapy. All patients received vitamin B12, folic acid and dexamethasone. Patients whose disease had not progressed during the Alimta plus cisplatin induction and who had an ECOG performance status of 0–1 (n=539) were randomized two-to-one to receive Alimta maintenance (500mg/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. Of the patients whose disease had not progressed during Alimta plus cisplatin induction therapy and who were randomized to receive maintenance therapy, 44% versus 42% achieved a complete or partial response to induction therapy and 53% versus 53% had stable disease after induction treatment in the Alimta and placebo arms, respectively.
Alimta, a folate analog metabolic inhibitor, is also indicated as a single-agent for the treatment of locally advanced or metastatic NS NSCLC after prior chemotherapy, and for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery, in combination with cisplatin.
For more information visit www.alimta.com or call (800) 545-5979.