OSI Pharmaceuticals (OSIP) - formerly Oncogene Message Board

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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene

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To: dalroi who wrote (203)	4/10/2003 7:00:46 PM
From: Miljenko Zuanic	Read Replies (1) of 447

Thanks Stafan. Iressa trial was regardless HER1 assay and positive tumor. Zeneca went with this approach because of the indication of drug secondary mechanisms, apoptosis. Also, Zeneca said from day one that rash was not predictor for response, while DNA thinks opposite, it is. Tarceva, C225 and ABX-EGF are for HER1 positive, so there is already screen of the subjects who were more likely to respond, based on biology. BTW, <<In addition to concluding that the trial should continue, the DMC recommended that study treatment be discontinued at the time of disease progression or the start of second-line chemotherapy or radiation due to a safety signal.>> Front line NSCLC trial, because survival is co-primary endpoint, allowed continued Tarceva administration in progressed subject with hope that drug will slow down progression and bring survival benefit. In addition to safety concern sound like there was no benefit in this group, or that positive data would be weighted on responded subjects. Miljenko

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