The 700mg dose appears to be the most effective up to 24 weeks, as that’s as far as the 700mg data goes. But even the 525mg dose is effective in a good majority of the subjects.
Wow is right. This is crazy insane. Will BP move? Obviously this is going to threaten SOC...Hello Gilead did you see that...I’m sure they were aware before CROI. This science is ridiculously impressive. Am I missing something?
100% suppression they see with 700 mg when overlap at the beginning of treatment with HAART 5X half life of Leronlimab , so instead of 1 week as in protocol , is 2-3 weeks. Excellent !!
The very last Investor presentation, which spells out Monotherapy PE is from 03/01/2018. 300 pts, PE responder rate > 70%, SE achieved (may return to HAART).
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Poster data included for 700mg Group: 36 ongoing + 6 failure + 1 early-termination = 43 pts, or 36 ongoing + 7 failure = 43 pts.
The 100% 700mg performance for timepoint period 12-24 weeks is misleading for overall efficacy, they capped the 0-12 weeks 6/43 VL failure (14%) already and one early termination.
This gives us a maximum possible responder rate of 36/43 = 83.72% if all 36 ongoing patients would pass.
Note that the 525mg group of 8 completed + 62 ongoing (rest failure/terminated) has a maximum possible responder rate of 70/115 = 60.87%. Hence this group has already failed the PE!
Even worse the 350mg group: 57/229 = 24.89%.
Note that all ongoing pts would still need to pass to achieve given maximum responder rate.
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Now let's recapitulate some 700mg data:
Investor presentation slides from 11/08/18 (SHM) using the 23 pts 700mg rescue arm (failed 525mg rescue arm, dose escalation) said ~52% suppressed and 22% failures.
Investor presentation slides from 01/01/19 said ~90% of 700mg pts in first 1-16 weeks, w/o giving pts count.
Investor presentation slides from 2/11/19 said 100% of 22 700mg pts in first 10 weeks. So 6 of the additional patients had a VL rebound/failure.
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How many more can fail?
29% failure for 71% responder rate of 43 pts -> Limit 28% 12 pts failure, 72% 31 pts responder.
7 pts already failed (1 + 6), so we have a free buffer of 5 pts. It is tight, but gladly all 700mg failures occurred in the 0-12 weeks so far!
We still need all ongoing 36 patients to complete the last timeslot 24-48 weeks.
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Safety wise, we had 30 SAE incidents in total of 387 pts or 7.75%, where it is unknown whether these were definitely or probably related to PRO 140.
This is probably OK, but have no details about the nature of the SAEs yet.
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Bottom line is (only) 700mg is good enough to pass PE safely.
They say they want to enroll additional 200 pts across all 3 dosage groups, which IMHO is a waste of time. Why not simply enroll them to 700mg only? (See: Methods & Materials)
This will take some more time to conclude and only thereafter will we have negotiations for the pivotal trial.
While 700mg for mono looks good, I would like to see us concentrating just on that group and dismiss the lower dosage to safe time & resources.
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