ASCO: Antibody improves head and neck cancer results

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel antibody improved outcomes for patients with advanced and inoperable squamous cell carcinoma of the head and neck, researchers reported. Combined with radiation or chemoradiation, the substance -- a fully humanized monoclonal antibody dubbed nimotuzumab -- significantly outperformed either modality alone in an open-label randomized trial, according to K. Govind Babu, MD, of Kidwai Memorial Institute of Oncology in Bangalore, India, and colleagues. At the same time, there was little serious toxicity -- such as debilitating skin rash -- attributed to the compound, the researchers reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. It's the first randomized study of the drug to show clinical benefit without the toxicities associated with similar antibodies, the researchers said. In general, neither radiation nor chemotherapy provides a good outcome for patients with inoperable stage III or IVa squamous cell carcinoma of the head and neck. However, substances such as cetuximab (Erbitux) that target the epidermal growth factor receptor (EGFR) -- overexpressed in such tumors -- have improved outcomes. Nimotuzumab, like cetuximab, targets EGFR, but is highly selective for tumor tissues, limiting toxicity, the researchers said. The study enrolled 92 patients, and 76 were evaluable for efficacy. They were treated with radiation or chemoradiation (with cisplatin), with or without nimotuzumab. The substance was given by intravenous infusion of 200 milligrams over a 60-minute period, once a week for six weeks. In group A -- [...]

YM Biosciences reports positive nimotuzumab four-year survival data

Source: www.reuters.com Author: press release YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that an oral presentation at the American Society for Therapeutic Radiology and Oncology (ASTRO) 2009 Annual Meeting reported positive 48-month survival data for its EGFR-targeting antibody, nimotuzumab. The "BEST" trial was a randomized four-arm study treating patients with inoperable, locoregionally-advanced, stage III/IVa head and neck cancer with radiation alone, chemoradiation alone, or radiation or chemoradiation in combination with nimotuzumab. These data were a follow-up to 30-month survival data presented at ASCO 2009 and demonstrate that the benefit of adding nimotuzumab to radiation and chemoradiation is durable and persists for several years. "These data are convincing evidence that nimotuzumab is an efficacious and safe drug and highlight its potential in the head and neck cancer indication. In this respect we note that the National Cancer Centre of Singapore has initiated a global Phase III trial with nimotuzumab in the adjuvant setting for head and neck cancer patients," said David Allan, Chairman and CEO of YM BioSciences. "Activity of nimotuzumab in the BEST trial was similar to that demonstrated in separate trials with cetuximab in locally advanced head and neck cancer but there was no evidence that nimotuzumab's activity was accompanied by the advanced toxicities of the class." In the ASTRO presentation, Dr. Lokesh Viswanth, Kidwani Memorial Institute of Oncology, Bangalore, India described that the addition of nimotuzumab to radiotherapy (RT) [...]

2009-11-03T08:17:42-07:00November, 2009|Oral Cancer News|

YM Biosciences’s drug selected for Phase III head and neck cancer study

Source: www.pharmaceutical-business-review.com Author: staff YM BioSciences, an oncology company, has announced that the National Cancer Centre of Singapore has selected nimotuzumab, the company's EGFR-targeting drug, for evaluation in a multinational Phase III trial of more than 700 patients with cancers of the head and neck. The National Cancer Centre of Singapore (NCCS) said that it selected nimotuzumab because of its reported preferential safety profile compared with other epidermal growth factor receptor (EGFR)-targeting cancer drugs. The trial is sponsored by the NCCS in collaboration with Innogene Kalbiotech, YM's licensee for nimotuzumab for the region. The NCCS is the lead cancer center coordinating this clinical trial, which will involve approximately 22 institutions from 12 countries worldwide. The trial will treat patients with locally advanced squamous cell cancers of the head and neck immediately following surgery - the 'adjuvant setting'. Along with standard chemotherapy and radiotherapy, half of the patients will be administered nimotuzumab weekly for an eight week period. The primary endpoint for this study is two-year and five-year disease-free survival; the secondary endpoint is two-year and five-year overall survival. The countries involved in the trial include Japan, South Korea, Taiwan, Thailand, Indonesia, India, Pakistan, Singapore, Saudi Arabia, Israel, South Africa and Cuba. The trial is expected to expand into Canada and additional sites may also be added from the Philippines, Australia and the UK. The NCCS anticipates reporting initial results from the trial in approximately five years. David Allan, chairman and CEO of YM BioSciences, said: "This trial further expands the [...]

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