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Tuesday, May 11, 2021 9:45:43 AM
Why lenzilumab patients accepted for a study are really moderate to slightly severe , Why not really sick if drug THAT good?
Lenzilumab didn't do well with patients in the advanced stage of severe. So it probably won't do well with critical patients. It actually makes sense since GM-CSF is "upstream". GM-CSF is the cytokine responsible for starting the cytokine storm. Once the cytokine storm is on full blast, it is too late for lenzilumab.
The trial also had less efficacy with patients 85 years old and older. This also makes sense. A person needs a good immune system to reach the age of 85. The 85+yo age group doesn't experience the cytokine storm much and overall they have done better than younger age groups.
Lenz's whole study has 54% efficacy but further analysis brings some eyepopping results. Patients who are treated when they have been hospitalized for 2 days or less have 88% efficacy. When patients 85+ and patients in the advanced stage of severe aren't included, efficacy on the primary endpoint of preventing mechanical ventilation goes up to 296%. The mortality benefit in this same group is 217%.
Naysayers might argue that I am datamining or cherry picking but I disagree. It could have been predicted that the 85+ and advanced stage severe patients wouldn't have efficacy. I think the FDA will give an EUA and give guidance that patients should be administered lenzilumab immediately after being hospitalized. Unfortunately, the 85+ age group might have to be excluded or it could possibly be left up to the physician.
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