YM Bioscience reports Phase II data for nimotuzumab in metastatic colorectal cancer
Overall Survival And Disease Control Outcomes, Coupled With Low Toxicity, Support The Continued Development Of The EGFR Antibody In Patients With Colorectal Cancer
YM BioSciences Inc. announced preliminary results obtained from its open-label, Phase II study (YMB1000-015) of nimotuzumab in patients with irinotecan-refractory, metastatic colorectal cancer (mCRC). The data are based on 58 evaluable patients of the 61 enrolled in the trial. The trial was conducted at 10 centres across Canada and consisted of treatment with 400 mg of nimotuzumab weekly plus irinotecan in patients refractory to irinotecan alone, with patients remaining on nimotuzumab until disease progression.
"These preliminary data are released upon our being advised that the trial has now reached the point at which more than 50% of the patients have died. The overall survival (OS) and disease control rate (DCR) for patients receiving nimotuzumab compare well with published results in similar patient populations treated with cetuximab, a currently marketed EGFR monoclonal antibody. Nimotuzumab also continues to display a safety profile unequalled in its class. This low incidence of toxicity with nimotuzumab may be related to differences reported in its interaction with EGF receptors compared with other EGFR targeting antibodies," said Dr. Paul Keane, Director of Medical Affairs for YM BioSciences.
The prospective primary endpoint of YMB1000-015 is objective tumour response rate (RR) with secondary endpoints that include overall survival, the rate and duration of stable disease, and progression free survival (PFS). The RR was 3.4% while the disease control rate reported was 50%, consisting of 27 patients with stable disease and two patients with partial response as determined using RECIST criteria. Median PFS was 12 weeks. Overall survival (Kaplan-Meier) in the evaluable patients was 9.3 months.
"The median overall survival of 9.3 months and disease control rate of 50% together with the exceptional safety profile of nimotuzumab support continuing development of nimotuzumab in patients with colorectal cancer," noted Dr. Amil Shah, medical oncologist and Chair, Gastrointestinal Tumor Group at the BC Cancer Agency and Principal Investigator for the trial.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
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