Lilly Suspends Approval Plans for Alimta in Head and Neck Cancers
In October of 2010, Eli Lilly, a global pharmaceutical manufacturer headquartered in Indianapolis, Indiana, announced that it was abandoning plans to have its established drug Alimta approved by the U.S. Food and Drug Administration, or FDA, for the treatment of head and neck cancer.
The move followed an announcement from Lilly that Phase III trials using Alimta in combination with cisplatin to evaluate its effectiveness in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet previously established overall survival goals.
Data was presented for the first time on Oct. 11 at the 35th Annual Meeting of the European Society for Medical Oncology, or ESMO, and showed that the Phase III portion – the biggest trial conducted in SCCHN so far – failed to deliver expected results among 795 patients.
The study, which delivered Alimta/cisplatin every three weeks to one group, with a control group receiving cisplatin plus a placebo, showed only an additional month on the median survival rate as compared to cisplatin alone (or 7.3 months versus 6.3 months), with no significant improvement in the quality of life in either group.
The results were not considered a “statistical improvement”. As a result, Lilly will not be asking the FDA or the EMA (the European Medicine Agency) to approve marketing activities for Alimta for that purpose (head and neck cancers).
Reportedly, according to lead researcher Professor Susan Urba, M.D. (of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center), the results are “disappointing but not surprising”, given the difficulty of treating metastatic or localized but advanced head and neck cancers.
However, the trials may not be a total loss. Study participants were originally grouped into nine sections, based on their ECOG status of 0 or 1. ECOG is a statistical tool used to calculate cancer patients’ disease progression, quality of life and prognosis.
In the study, two of the nine groups showed improved survival rates in final assays; that is 8.4 months for the Alimta/cisplatin group as compared to 6.7 months for the cisplatin\placebo group. These study participants accounted for 87 percent of the total, and – as Dr. Urba noted – the valuable information obtained from the study will enable pharmaceutical companies like Lilly and oncologists in general to plan more revelatory future clinical trials for head and neck cancers.
Another group, this one with mouth and throat cancers, showed even better survival results: 9.9 months for the Alimta/cisplatin group versus 6.1 months for the cisplatin/placebo group, although no significant advantage was noted for patients whose primary disease site included the mouth itself, the part of the pharynx that connects to the esophagus (the hypopharynx), the larynx, or a classification simply known as “other”.
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