But even more important the difference will be to

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But even more important the difference will be to some patients who without ICIs for one year , will die needlessly .

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I agree that it would be best if patients would receive ICI as soon as their PD-L1 levels justify. In the worst case scenario, there will be a rollover protocol. In such case, patients will receive ICI as soon as they show disease progression, assuming they have elevated PD-L1. There is no waiting for a year.

Although I am hopeful that FDA accepts the amended protocol, it wouldn't be completely surprising if they did not. Recall, Replimune RP1 received a CRL in part because FDA was concerned with determining the individual contribution of RP1 as it was being used in combination with nivolumab. Agenus' phase 3 trial in mcrc was delayed for a year because FDA wanted an additional trial arm to be able to determine individual contribution of their drug combination. It took experts' petitioning to get FDA to relent. Just a couple days ago, Oncolytics Biotech agreed on their pivotal phase 3 trial in mPDAC. Trial arms are chemo, chemo+pelo, chemo+pelo+ICI. FDA may very likely want to see the efficacy of leronlimab as a stand alone.