YM BioSciences Inc. has announced that the National Cancer Centre of Singapore (NCCS) has selected nimotuzumab, YM'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 NCCS stated that it selected nimotuzumab because of its reported preferential safety profile compared with other EGFR-targeting cancer drugs. The trial is sponsored by the NCCS in collaboration with Innogene Kalbiotech Pte. Ltd, (IGK) YM's licensee for nimotuzumab for the region.
"The efficacy of nimotuzumab as an epidermal growth factor receptor targeted therapy is likely to be comparable to drugs of the same class. However, what is likely to set nimotuzumab apart is its low toxicity and favourable safety profile," said Dr. Rikrik Ilyas, Director of IGK. "Patients are spared the discomfort of severe skin rashes and may benefit from an enhanced quality of life. Both patients and physicians may also benefit from lack of hypomagnesemia often related to treatment with other anti-EGFR targeted drugs. IGK is pleased to support the NCCS in this investigator-initiated trial of nimotuzumab."
The NCCS is the lead cancer centre 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 United Kingdom. The NCCS anticipates reporting initial results from the trial in approximately five years.