YM BioSciences’ licensee for nimotuzumab, Daiichi-Sankyo has initiated the enrollment of a phase II trial. It is to evaluate nimotuzumab, in combination with radiation therapy/cisplatin/vinorelbine, in first-line curative intent patients with stage III non-small-cell lung cancer (NSCLC).
The trial will evaluate the treatment completion rate and numerous secondary endpoints, including response rate, progression-free survival, and the overall survival rate at 12 and 18 months, as well as toxicity.
David Allan, Chairman and CEO, YM BioSciences, said: This is the latest of eleven Phase II and III trials currently being conducted by YM and/or its four licensees, highlighting the tremendous breadth of clinical activity focused on nimotuzumab and the benefits of our cooperative model which permits the undertaking of such a comprehensive international program.
Of these trials, three involve patients with NSCLC at various stages – curative, palliative radiotherapy and metastatic. NSCLC is an important indication for nimotuzumab as treatments typically involve radiation-containing regimens that have been demonstrated to enhance the expression of EGFR. Nimotuzumab’s differentiated mechanistic attributes result in it selectively targeting tissues over-expressing EGFR while avoiding normal tissue. The debilitating and dangerous side effects observed with the marketed EGFR-targeted drugs result from their indiscriminant targeting of normal healthy tissues in addition to their binding to tumor, he added.