Single agent ORR in relapsed and refractory setting for any cancer is minimum 20% to have chance for accelerated approval. I have followed ONXX for a long time. Before carfilzomib result was announced, most people didn't expect they could clear 20% hurdle based on previous result - they needed higher dose due to it is a similar drug to Velcade. Each agent is different. It seems in 520 case higher dose didn't result better response rate, probably due to toxicity. Look at the poster, patients with minimum response and SD are still on treatment. They could turn into responder. As I said, wait until phase 2 data to make judgement.
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