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$HGENQ @VeryJerry hey Jerry. So being so close to this for a long time and therefore running the risk of losing objectively I asked a close friend of mine who’s a hardcore academic to have a look at the pre-print of LIVE-AIR for me…….his comments below.

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 hey Jerry. So being so close to this for a long time and therefore running the risk of losing objectively I asked a close friend of mine who’s a hardcore academic to have a look at the pre-print of LIVE-AIR for me…….his comments below.

@VeryJerry I’ve finished reviewing that paper. My initial thoughts are: there are some pretty hardcore exclusions 1) pregnant/must agree to use contraception for a period of time after treatment. 2) can’t have IL-6 blockers which are established standard of care. The trial was done at 29 sites but only recruited 520 patients. This is always a worry for me as it implies there was some pretty strong screening processes going on at those sites. Were only the best possible candidate patients taken forward into the trial? There are some weird parts of the statistical analysis. The modified ITT analysis excluded a large number of patients who went onto IMV (the primary end point) because the hospital ran out of high flow O2. I’m not sure what to make of that. They do give the unmodified ITT which agrees largely with the mITT though. The KM curves are *only* shown for the mITT analysis, which I think is dodgy. I would have liked to have seen an as per protocol analysis for comparison.

 I’ve finished reviewing that paper. My initial thoughts are: there are some pretty hardcore exclusions 1) pregnant/must agree to use contraception for a period of time after treatment. 2) can’t have IL-6 blockers which are established standard of care. The trial was done at 29 sites but only recruited 520 patients. This is always a worry for me as it implies there was some pretty strong screening processes going on at those sites. Were only the best possible candidate patients taken forward into the trial? There are some weird parts of the statistical analysis. The modified ITT analysis excluded a large number of patients who went onto IMV (the primary end point) because the hospital ran out of high flow O2. I’m not sure what to make of that. They do give the unmodified ITT which agrees largely with the mITT though. The KM curves are *only* shown for the mITT analysis, which I think is dodgy. I would have liked to have seen an as per protocol analysis for comparison.

@VeryJerry A lot of the secondary end points do not appear to be pre-specified, and so I don’t think we should interpret them too strongly. Lastly, in the discussion, they make a big argument against Tocilizumab, by casting doubt over its efficacy. This is disingenuous as a large meta-analysis now shows that tocilizumab is clearly efficacious, though it is difficult to say if it is more or less efficacious than Lenzilumab based on this study.

 A lot of the secondary end points do not appear to be pre-specified, and so I don’t think we should interpret them too strongly. Lastly, in the discussion, they make a big argument against Tocilizumab, by casting doubt over its efficacy. This is disingenuous as a large meta-analysis now shows that tocilizumab is clearly efficacious, though it is difficult to say if it is more or less efficacious than Lenzilumab based on this study.

@VeryJerry In short. The paper reads like it was written by a drug company, and I think that was a mistake. I think the big journals will probably see through that, and either ask for a re-write so it is more balanced, or they will just reject it. It depends on how greedy the big journals are feeling, as this will obviously get good press

Oh, and the pre-registration for the trial lists 18 pre-specified secondary end points. Most of which aren’t reported. Instead they report some different ones.

 In short. The paper reads like it was written by a drug company, and I think that was a mistake. I think the big journals will probably see through that, and either ask for a re-write so it is more balanced, or they will just reject it. It depends on how greedy the big journals are feeling, as this will obviously get good press

Oh, and the pre-registration for the trial lists 18 pre-specified secondary end points. Most of which aren’t reported. Instead they report some different ones.

@VeryJerry So I think there is definitely potential here. The drug needs further evaluation from an external sponsor. But the IL-6 exclusion is going to make that logistically very difficult.

I suppose a good way to run a trial would be to put Tocilizumab vs. Lenzilumab head to head

 So I think there is definitely potential here. The drug needs further evaluation from an external sponsor. But the IL-6 exclusion is going to make that logistically very difficult.

I suppose a good way to run a trial would be to put Tocilizumab vs. Lenzilumab head to head

@VeryJerry my thoughts:
A lot of what he’s said is fair to pick up like the mITT question which I think has been adequately answered although is a fair point to pick up on when reading the paper for the first time with no background.
Also as I said he is a pure academic and this is is part academia and part commercial and I personally think Mayo running stamping things will take care of that concern.
Additionally I’m pretty sure there will never be a Lenz, Toc trial on grounds of cost, ethics, time and general pragmatism 
The only thing I wasn’t sure about was absolute comparison to Toc efficacy……have you got any evidence to hand quickly to answer that query??
Thanks

 my thoughts:
A lot of what he’s said is fair to pick up like the mITT question which I think has been adequately answered although is a fair point to pick up on when reading the paper for the first time with no background.
Also as I said he is a pure academic and this is is part academia and part commercial and I personally think Mayo running stamping things will take care of that concern.
Additionally I’m pretty sure there will never be a Lenz, Toc trial on grounds of cost, ethics, time and general pragmatism 
The only thing I wasn’t sure about was absolute comparison to Toc efficacy……have you got any evidence to hand quickly to answer that query??
Thanks

@Sheriff_Nottingham thanks for sharing , always appreciate an objective viewpoint and always up for constructive debate :) 

I think you touched on the first two points - the paper is a Mayo Clinic paper with the head of the covid task force attached so no journal will have an issue publishing their POV. Lenz is already being studied and sponsored by various organizations across different indications (see pipeline) but also in covid by the NIH. The guidelines released yesterday really lend a lot of credibility to the trial results as well. I’ll post screenshot below.

As far as the main point I think here is , is Lenzilumab better than Tocilizumab? My answer is that based on the data it should be used at a completely different stage of disease course so it’s hard to compare the two. As far as head to head here is the chart Humanigen published when compared to the Recovery Trial (main trial used for EUA)

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 thanks for sharing , always appreciate an objective viewpoint and always up for constructive debate :) 

I think you touched on the first two points - the paper is a Mayo Clinic paper with the head of the covid task force attached so no journal will have an issue publishing their POV. Lenz is already being studied and sponsored by various organizations across different indications (see pipeline) but also in covid by the NIH. The guidelines released yesterday really lend a lot of credibility to the trial results as well. I’ll post screenshot below.

As far as the main point I think here is , is Lenzilumab better than Tocilizumab? My answer is that based on the data it should be used at a completely different stage of disease course so it’s hard to compare the two. As far as head to head here is the chart Humanigen published when compared to the Recovery Trial (main trial used for EUA)

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@VeryJerry thanks Jerry. My understanding Was Toc was to be used later in the progression. Is that part of the formal EUA licensing or is it granted for all severe/critical (ie ordinal 3 onwards)?

 thanks Jerry. My understanding Was Toc was to be used later in the progression. Is that part of the formal EUA licensing or is it granted for all severe/critical (ie ordinal 3 onwards)?

@Sheriff_Nottingham it’s currently granted for all severe/critical - as long as it’s used with steroids. 

Based on the exploratory analysis LIVE-AIR it’s clear that Lenz should be used early in hospitalization. 

It makes a lot of sense as increased Levels of Gm-CSF upregulate IL-6 along with a host of other cytokines 

Earlier treatment will prevent progression to severe course disease and that’s what the goal is of any hospital right?

 it’s currently granted for all severe/critical - as long as it’s used with steroids. 

Based on the exploratory analysis LIVE-AIR it’s clear that Lenz should be used early in hospitalization. 

It makes a lot of sense as increased Levels of Gm-CSF upregulate IL-6 along with a host of other cytokines 

Earlier treatment will prevent progression to severe course disease and that’s what the goal is of any hospital right?

@VeryJerry I don’t know your sense of humour but this tickled me. I sent the guy that provided that review a précis of your retorts which is what the allying fear comment relates to……..this was his reply. If you want someone to find any flaw in any paper this is your guy because he’s so focused on the science and methodology! His responses have only made me more bullish!

 I don’t know your sense of humour but this tickled me. I sent the guy that provided that review a précis of your retorts which is what the allying fear comment relates to……..this was his reply. If you want someone to find any flaw in any paper this is your guy because he’s so focused on the science and methodology! His responses have only made me more bullish!

@Sheriff_Nottingham I never take offense to good debate , in fact I would be worried if people had only positive things to say. 

Send him the nick mark Twitter thread and see what he says.. 

I’d also suggest that he take a read of the thwaites paper to get started - 

https://immunology.sciencemag.org/content/6/57/eabg9873

Remember this trial was started at the outset of the pandemic - it was designed before we learned many things about covid progression that we know today. I’d say they did a damn good job either way butThere’s a reason why many things in live-air were not pre specified , because we learned them along the way with papers like thwaites.

Critical respiratory failure in COVID-19 is an inflammatory disease-several proinflammatory factors correlate with disease severity in COVID-19, and anti-inflammatory treatments such as corticosteroids and anti-IL-6 monoclonal antibodies can reduce mortality. There is a need to identify additional "targetable" proinflammatory factors that correlate with disease severity. Here, Thwaites et al .

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Inflammatory profiles across the spectrum of disease reveal a distinct role for GM-CSF in severe COVID-19

 I never take offense to good debate , in fact I would be worried if people had only positive things to say. 

Send him the nick mark Twitter thread and see what he says.. 

I’d also suggest that he take a read of the thwaites paper to get started - 





Remember this trial was started at the outset of the pandemic - it was designed before we learned many things about covid progression that we know today. I’d say they did a damn good job either way butThere’s a reason why many things in live-air were not pre specified , because we learned them along the way with papers like thwaites.

@Sheriff_Nottingham @VeryJerry I want to thank you for the discussion here. Though I have nothing to add I learned a lot from reading both your perspectives.

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 I want to thank you for the discussion here. Though I have nothing to add I learned a lot from reading both your perspectives.