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FDA approved pemetrexed plus cisplatin for non-squamous NSCLC
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The FDA this week approved pemetrexed in combination with cisplatin as first-line therapy for locally advanced metastatic non–small cell lung cancer in patients with nonsquamous history, according to a press release.
Pemetrexed for injection (Alimta, Eli Lilly) is not approved for treatment in patients with squamous cell NSCLC.
The FDA reviewed data from a phase-3, open-label, randomized study of pemetrexed for injection plus cisplatin vs. gemcitabine HCl (Gemzar, Eli Lilly) for injection plus cisplatin. The study included 1,725 patients.
Median survival was 10.3 months for both treatment arms (adjusted HR=0.94). Median PFS was 4.8 months for pemetrexed plus cisplatin and 5.1 months for gemcitabine HCl plus cisplatin (adjusted HR=1.04). Overall response rates were 27.1% for pemetrexed plus cisplatin and 24.7% for gemcitabine HCl plus cisplatin.
The researchers examined the effect of histology on OS and found that median survival for NSCLC was 11 months for pemetrexed plus cisplatin and 10.1 months for gemcitabine HCl plus cisplatin (unadjusted HR=0.84). Median survival for patients with squamous cell histology was 9.4 months for pemetrexed plus cisplatin and 10.8 months for gemcitabine plus cisplatin (unadjusted HR=1.22).
Fewer cases of hematologic toxicity and blood transfusions occurred among patients assigned to pemetrexed plus cisplatin, compared with gemcitabine HCl plus cisplatin. Patients in the pemetrexed and cisplatin group were also less likely to use growth factors. Vomiting, neutropenia, leucopenia, anemia, stomatitis/pharyngitis, thrombocytopenia and constipation were the most common adverse events reported in the pemetrexed plus cisplatin arm with an incidence rate of 20% or greater.
Pemetrexed for injection is currently approved in combination with cisplatin for treatment of patients with malignant pleural mesothelioma and as a single agent for second-line therapy in patients with locally advanced or metastatic NSCLC after chemotherapy.