Alimta Beats Gemcitabine In Some NSCLC Types
This article was originally published in The Pink Sheet Daily
Executive Summary
But Phase III results show similar efficacy in patients overall.
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Treatment with Lilly's Alimta (pemetrexed) in advanced non-small cell lung cancer was shown to be more efficacious than gemcitabine (Lilly's Gemzar and generics) in certain tumor types, according to Phase III study results published in the May 27 Journal of Clinical Oncology, but efficacy in the total patient population was the same for both regimens. Comparing Alimta and Gemzar in combination with cisplatin therapy in 1,725 chemotherapy-naive patients, the randomized trial met its primary endpoint: non-inferiority to overall survival. The study is the first prospective Phase III NSCLC trial to show differences in survival based on histologic type, write Giorgio Scagliotti, University of Torino, Italy, et al. "While [NSCL] cancer has typically been treated as one disease, this study confirms that histology, or tumor type, can provide a clue as to which treatment regiment works best for a particular tumor type," the investigator noted in a May 28 statement. "If we can tailor the therapy for better results, we are closer to improving outcomes" for the disease, he added. In December, Lilly held an analyst presentation during which the Indianapolis pharma said that personalized medicine would be a significant focus in its evolving research and development model (1 (Also see "Lilly Aims To Have 30 NMEs In Clinic By 2009" - Pink Sheet, 6 Dec, 2007.)). Results of the Phase III trial showed that overall survival was statistically superior in the Alimta arm in patients with adenocarcinoma (12.6 months versus 10.9 months) and with large-cell carcinoma histology (10.4 months versus 6.7 months). In patients with squamous cell histology, OS favored the Gemzar arm over the Alimta group, 10.8 months versus 9.4 months. In all patients, OS in the Alimta/cisplatin group was the same as the Gemzar/cisplatin group - 10.3 months (95 percent confidence interval, 0.84 to 1.05). In the Alimta arm, there were lower rates of grade 3 or 4 neutropenia, anemia and thrombocytopenia, febrile neutropenia and alopecia. However, incidences of grade 3 or 4 nausea were more common. The firm submitted Alimta for the first-line indication in the first half of 2007 and is awaiting FDA approval. Lilly recently released an early abstract containing data on maintenance therapy with Alimta ahead of the American Society of Clinical Oncology meeting, showing significant improvement in progression-free survival (2 (Also see "ASCO Preview Highlights Study Of Alimta For First-Line NSCLC" - Pink Sheet, 15 May, 2008.)). The drug is approved for second-line NSCLC after progression on first-line chemo, based on response rate data, and for first-line treatment of malignant pleural mesothelioma (3 (Also see "Lilly Alimta To Be Available In Two Weeks Following Five-Month Review" - Pink Sheet, 5 Feb, 2004.)). -Brooke McManus ([email protected]) |