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"While preliminary, these results are compelling because we observedclinical benefit (Partial Response or Stable Disease) in every one of the 13patients so far enrolled in this study. A study by The National CancerInstitute of Canada demonstrated that patients with advanced NSCLC with StableDisease as best response for treatment had Overall Survival similar topatients with Partial Response. The relatively long survival times observed inthe first cohort of this trial are encouraging and are in agreement with theNCIC observations," said Dr. Igor Sherman, YM's Director of Clinical Research."Although nimotuzumab specifically targets the EGF receptor, the reportedabsence of side effects, particularly the absence of severe rash, makesnimotuzumab therapeutically attractive in this setting."
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The Phase I component enrolled patients at three centers in Canada and isevaluating the safety and feasibility of administrating nimotuzumab at threedose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30 Gyin 10 fractions). The data will be used to select the optimal effective dosefor the randomized Phase II component of the study, in which Overall Survivalwill be the primary endpoint.
Of the six patients enrolled in the 1st cohort (100mg), four PartialResponse (PR) and two Stable Disease (SD) were reported as at August 14, 2007.Median Overall Survival of the group was 41.5 weeks. All patients ultimatelyprogressed. Two severe adverse events have been reported, neither causallyattributable to nimotuzumab. A notable absence of grade III/IV rash ordiarrhea in this cohort was reported.
Of the seven patients enrolled in the 2nd cohort (200mg) of the study, twoPR and five SD were reported as at August 14, 2007 Median overall survival ofthe group has not been reached but currently exceeds 25 weeks. There has beena notable absence of grade III/IV rash or diarrhea reported in this cohort.
Enrolment is now ongoing into the third cohort, to be treated at 400 mgper dose level, and accrual is anticipated to be completed by the end of 2007.
YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. isconducting a parallel trial in Korea with a common protocol. This structure isdesigned to accelerate overall recruitment and lower the costs to theparticipants. The interim report from Phase I Korean patients is anticipatedearly in 2008.
The poster presentation is entitled "Preliminary Results Of An EscalatingDose (Phase I /II Clinical) Trial Of The Anti EGFR Monoclonal AntibodyNimotuzumab In Combination With External Radiotherapy In Patients DiagnosedWith Stage IIB, III or IV NSCLC Unsuitable For Radical Therapy" by Gwyn Bebb,Colum Smith, Anthony Brade, Stewart Rorke and Igor Sherman. The poster, P3 -023, will be on display on September 5 & 6 at Atlantic Halls 5 - 8 in postersession 3 - Novel Therapeutics: Molecular Therapeutics.
Nimotuzumab
Nimotuzumab is a humanized monoclonal antibody that targets the epidermalgrowth factor receptor (EGFR). To date nimotuzumab has been administered toapproximately 900 patients in more than a dozen clinical trials and on acompassionate basis. It has been approved in several c
