The company will conduct a Phase II trial in approximately 128 patients with non-small cell lung cancer (NSCLC) and a Phase II trial in approximately 88 patients with brain metastases from NSCLC. Enrollment for both trials is expected to be initiated in Canada in the first quarter of calendar 2009 and YM anticipates adding sites from other countries into the trials.
The randomized, double-blind, Phase II NSCLC study will evaluate nimotuzumab’s survival benefit in combination with external radiotherapy in patients diagnosed with stage IIb, III NSCLC who are ineligible for treatment with radical chemoradiotherapy or in stage IV NSCLC patients with chest disease including those eligible for palliative radiotherapy.
This trial will enroll approximately 128 patients over 18 months followed by an 18-month follow-up period and will likely include 20 investigational centers in Canada plus additional centers in other countries. Nimotuzumab will be administered weekly, starting on the first day of radiotherapy, until disease progression. Chemotherapy may be provided to patients in either arm at the discretion of the physician.
The other randomized, double-blind, Phase II brain metastases study will compare nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. The trial is designed to enroll approximately 88 patients over 12 months followed by a 12-month follow-up period and will likely include 12 investigational centers in Canada plus additional centers in other countries.
Nimotuzumab (200mg IV infusions) will be administered weekly during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Radiotherapy will consist of 30Gy, in 10 fractions of 3Gy/day. Patients will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms.
The primary efficacy endpoint is intracranial disease progression over six months. The secondary endpoints are overall survival (OS); time to neurologic progression or death with evidence of neurologic progression; OS rate at six months; time to intracranial disease progression; and time to overall progression.
David Allan, chairman and CEO of YM BioSciences, said: The results from these trials could contribute significantly to the data package for nimotuzumab which will be used to expand its approval across international markets. Specific to our North American regulatory strategy, these trials form part of the registration program and should generate robust data relatively rapidly.