If so, why do it using bevacizumab when ll does VE

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If so, why do it using bevacizumab when ll does VEGF inhibition already? Yes, why not start pre-clinical, we are at $0.13 anyway? Why not go for monotherapy?

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With a deadly disease the FDA is going to insist on pairing with a standard of care or best in class drug so that the patient will get some benefit even if the new drug is a failure. The best thing about the inflammation in HIV trial is that it will show exactly what leronlimab does. In future trials we may not have to be paired with a drug that duplicates what leronlimab does.

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Yes, I know this Phase II will be quick as we are going for ORR and not OS or PFS, so ORR can be determined as quick as 3 months while OS needs over a year. So, maybe we can advance to Phase 3 much quicker if that is what you're thinking.

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The FDA may allow only ORR but I would be inclined to think OS and PFS would be secondary outcomes.

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Are there any advantages of using the chemo as well? Just to see how much better the chemo works when ll is added?

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Leronlimab stops tumor DNA repair when used with chemo. But as this trial is for fourth line treatment where chemo has already failed it wouldn't be used. At the point where the FDA understands that leronlimab works on a wide range of cancers we should be allowed to trial directly as first or second line treatment.

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Can a Phase III be designed that only looks at ORR as end point if we go this quicker route? Do we need to look at OS and PFS in the Phase III in order to write a BLA and gain approval? or is OS an PFS also necessary for the BLA and approval?

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I can't see the FDA approving any cancer drug without OS and PFS. Response rate shows that the drug is working but OS and PFS shows what the actual benefit is.