Bispecifics for myeloma are promising. As I said earlier, I’d like them all get accelerated approval.
But as clinicians we must swiftly adjust dosing schedule & be watchful to risk of severe infections & other cancers that can occur with prolonged T cell suppression. #IMS2022
But as clinicians we must swiftly adjust dosing schedule & be watchful to risk of severe infections & other cancers that can occur with prolonged T cell suppression. #IMS2022
Overall survival is a composite endpoint. It not only depends on efficacy but also safety.
At this meeting talking to colleagues, I am increasingly aware of the risk of serious infections with these agents.
At this meeting talking to colleagues, I am increasingly aware of the risk of serious infections with these agents.
As @TomBmt133 pointed out severe infections and deaths due to infections with bispecifics and CART must be considered possibly related to therapy and not classified as unrelated.
As we move bispecifics & CART to frontline we must monitor survival outcomes in a continuous reassessment model. We know the benchmark survival rates at 1 and 2 years. So even if trials are not designed for OS endpoint we need to make sure that the benchmarks are met or exceeded.
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