|A CR is not a cure if the patient relapses within a few weeks or months. Because solid cancers can relapse even years after a CR in traditional chemotherapy (mainly seen with indolent breast cancers) the standard metric used is remission that lasts at least 5 years is probably a cure. We have never achieved that. I dont think we had 6 CR in the TNBC study, I thought it was 2? |
To become first line therapy we would need to do a large head to head P3 trial comparing 132 to current standard of care. That is a long path to getting approval, many years, so that will have to wait till we get AA for 3rd line therapy. Ultimately 132 will expand into other solid cancers and advance up the food chain especially in combination therapy trials. 10 year process to discover how to fully utilize this drug. Look at the history of rituxan, initially approved as a single agent for low grade NHL, now being used for a variety of NHL, dosing schedules, and autoimmune diseases.