Lilly presents new data in head and neck cancer – a difficult to treat cancer with poor survival rates

Source: www.prnewswire.com Author: press release Eli Lilly and Company announced today that its global Phase III trial evaluating Alimta® (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO). The Phase III study, the largest trial conducted in SCCHN to date, evaluated Alimta in combination with cisplatin compared with placebo plus cisplatin given every three weeks in a total of 795 patients. The primary objective of the study was to determine overall survival. Patient quality of life was also assessed, in addition to several pre-planned sub-group analyses. The Alimta/cisplatin regimen showed a median overall survival of 7.3 months compared with 6.3 months with cisplatin alone, a result not considered a statistically significant improvement (p=0.082). There was no significant difference in the quality of life scores for patients treated with either ALIMTA/cisplatin or cisplatin alone (p=0.200). As a result, Lilly will not be submitting marketing authorization applications for Alimta in SCCHN with either the U.S. Food and Drug Administration (FDA) or the European Medicine Agency (EMA). "The fact that combination treatment with pemetrexed and cisplatin did not improve overall survival in this study is disappointing, although perhaps not surprising given how difficult it can be to effectively treat metastatic or locally advanced head and neck cancer," said the study's [...]

ASCO: Non-platinum regimen works in head, neck cancer

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel non-platinum-based regimen was efficacious in recurrent or metastatic squamous cell head and neck cancer, researchers said. The combination of pemetrexed (Alimta) and bevacizumab (Avastin) yielded a response rate of 30% in a small single-arm trial, according to Athanassios Argiris, MD, of the University of Pittsburgh, and colleagues. The combination also increased the length of time before patients progressed, and increased median overall survival, Argiris and colleagues reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. Patients with recurrent or metastatic disease typically have a poor prognosis, the researchers said, with median survival between six and nine months with standard chemotherapy. But, in other research, adding the monoclonal antibody cetuximab (Erbitux) to platinum-based chemotherapy increased survival, they said. Bevacizumab is a monoclonal antibody that targets the vascular epithelial growth factor (VEGF), which is expressed in squamous cell head and neck cancer; high levels of VEGF correlate with poor outcome, they noted. The researchers hypothesized that the antibody might enhance the activity of pemetrexed, which is a multi-targeted antifolate indicated for malignant pleural mesothelioma and non-small cell lung cancer. To test the idea, they analyzed results of treating 37 patients given 500 mg/m2 of pemetrexed and 15 mg/kg of bevacizumab intravenously every 21 days until disease progression. Patients were also given folic acid and vitamin B12. The primary endpoint of the study was time to progression, they said, but the researchers [...]

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