Median progression-free survival measured from randomization was 4.1 months on the ALIMTA arm as compared to 2.8 months on the placebo arm with a hazard ratio of 0.62. Stated another way, the study showed that patients on the ALIMTA continuation maintenance arm had a 38 percent improvement of survival without disease worsening, compared to the placebo arm.
The most severe adverse reactions (grades 3-4) with ALIMTA as a single agent versus placebo, respectively, for these patients in the maintenance setting were anemia (4.8% vs 0.6%); neutropenia (3.9% vs 0%); fatigue (4.5% vs 0.6%).
Common adverse reactions (all grades) with ALIMTA as a single agent versus placebo, respectively, were anemia (15% vs 4.8%); neutropenia (9% vs 0.6%); fatigue (18% vs 11%); nausea (12% vs 2.4%); vomiting (6% vs 1.8%); mucositis/stomatitis (5% vs 2.4%); edema (5% vs 3.6%).
U.S. ALIMTA ApprovalsIn 2004, ALIMTA received consecutive approvals: it was the first agent to be approved in combination with cisplatin as a treatment for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy treatment. 1In 2008, ALIMTA, in combination with cisplatin, was approved as a first-line treatment for locally advanced or metastatic NSCLC for patients with nonsquamous histology. At the time of the first-line approval, the FDA also approved a change to the second-line indication. ALIMTA is now indicated as a single agent for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC after prior chemotherapy. In 2009, ALIMTA was approved as a maintenance therapy for locally advanced or metastatic NSCLC, specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.