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Posted On: 05/29/2022 6:40:04 AM
Post# of 153939
So CytoDyn was basing its BTD for mTNBC on the pooled analysis of the 3 trials. It was not based on a previously defined, previously FDA authorized Phase 2 trial. Rather, CytoDyn was in the process of conducting these 3 trials and they were getting good results. They therefore decided to compile a BTD application based upon the mixing of the data of these 3 similar, yet different cancer trials.
How were they the same, they all evaluated LL against mTNBC. Only mTNBC patients were selected out of the individual studies to be a part of this analysis.
How were they different?
Eligibility criteria may have differed slightly.
Phasing was different. Carboplatin was Phase 1b/2; Basket trial was Phase 2; Compassionate was Expanded Access.
Dosing of LL was different between trials.
Agreed. BigTime.
Precisely as you say, The results of this Pooled Analysis prove it out.
CytoDyn should have abided by the protocols of the individual trials and continued following these patients as well as continued scheduled LL dosing as per protocol of the trial until death or intolerable toxicity. We have no reason to believe they had not.
If they did as they should have, more than likely, regardless of the compassionate patients who were on their death beds, the results will be wonderful and even more reason to grant BTD.
How were they the same, they all evaluated LL against mTNBC. Only mTNBC patients were selected out of the individual studies to be a part of this analysis.
How were they different?
Eligibility criteria may have differed slightly.
Phasing was different. Carboplatin was Phase 1b/2; Basket trial was Phase 2; Compassionate was Expanded Access.
Dosing of LL was different between trials.
Quote:.
Pts received ≥1 dose of leronlimab alone (n = 2), with carboplatin (n = 11) or with physician’s choice (n = 15). Pts received 1-33 doses, ranging from 350mg (n = 9), 525mg (n = 16) or 700mg (n = 3)
Quote:
With it being equivalent to or much more likely better than Trodelvy without the side effects it would be criminal if the FDA didn't advance it to phase 3.
Agreed. BigTime.
Precisely as you say, The results of this Pooled Analysis prove it out.
CytoDyn should have abided by the protocols of the individual trials and continued following these patients as well as continued scheduled LL dosing as per protocol of the trial until death or intolerable toxicity. We have no reason to believe they had not.
If they did as they should have, more than likely, regardless of the compassionate patients who were on their death beds, the results will be wonderful and even more reason to grant BTD.
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