WASHINGTON -- The FDA has expanded the indication for pemetrexed injection (Alimta) to include maintenance therapy in combination with cisplatin for nonsquamous non-small cell lung cancer (NSCLC).
The FDA decision was based on data from a phase III trial of 939 patients with advanced nonsquamous NSCLC reported at the American Society of Clinical Oncology meeting in early June, 2012, which established its efficacy in maintenance therapy.
In that study patients were given 500 mg/m2 of pemetrexed injection on 21-day cycles with 75 mg/m2 of cisplatin, as well as B12 vitamins, folic acid, and dexamethasone. The 539 patients whose disease did not progress during the dual-treatment segment were randomized two-to-one to pemetrexed maintenance or placebo. Both study arms received best supportive care in addition to drug or placebo treatment.
Compared with placebo, pemetrexed treatment benefit was modest -- 44% of pemetrexed-treated patients achieved a complete or partial response to induction therapy versus 42% of patients, while 53% of patients receiving drug therapy and placebo had stable disease after sham or drug treatment.
However, patients receiving drug treatment had a significantly reduced risk of death (HR 0.78, 95% CI 0.64 to 0.96, P=0.02), and median progression-free survival for patients receiving pemetrexed was 4.1 months versus 2.8 months with placebo.
Adverse reactions for pemetrexed as a maintenance therapy during the trials included anemia, neutropenia, fatigue, nausea, vomiting, mucositis, stomatitis, and edema.
The drug was initially approved in 2004 as a combination therapy with cisplatin for malignant pleural mesothelioma where disease was unresectable or curative surgery was not possible and as a second-line treatment for locally advanced metastatic NSCLC after prior chemotherapy treatment.
Pemetrexed was approved as a first-line treatment for locally advanced or metastatic NSCLC in patients with nonsquamous histology in 2008. In 2009, the drug was given approval as a maintenance therapy for locally advanced or metastatic NSCLC in patients with nonsquamous histology following four cycles of platinum-based first-line chemotherapy without disease progression.
Cole Petrochko
Staff Writer
Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.
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