The other issue here is the exorbitant cost of these treatments versus the use of cheap widely available generic statins. Payers will not pay for these treatments out of label or guidelines.]]>

The other issue here is the exorbitant cost of these treatments versus the use of cheap widely available generic statins. Payers will not pay for these treatments out of label or guidelines.]]>

MRK also has KN-042 on-going, a 1L NSCLC Keytruda monotherapy study with an OS endpoint. The primary endpoint is efficacy in high expressers (greater that or equal to 50% PD-L1 expression) and a secondary endpoint of efficacy in lower expressers (expression from 1% to 49%).]]>

MRK also has KN-042 on-going, a 1L NSCLC Keytruda monotherapy study with an OS endpoint. The primary endpoint is efficacy in high expressers (greater that or equal to 50% PD-L1 expression) and a secondary endpoint of efficacy in lower expressers (expression from 1% to 49%).]]>

If you look closely at the nivolumab data, in the studies in 2L NSCLC where Opdivo was approved for any expression level, the benefit only comes for PD-L1 expressers greater than or equal to 10% expression in the biopsy samples.

BMY rolled the dice and lost.]]>

If you look closely at the nivolumab data, in the studies in 2L NSCLC where Opdivo was approved for any expression level, the benefit only comes for PD-L1 expressers greater than or equal to 10% expression in the biopsy samples.

BMY rolled the dice and lost.]]>

As an example, our knowledge to date about PD-1/PD-L1 inhibition led biotech/pharma professionals, like myself, to assume that CM-026 would be a positive study. Unfortunately the trial failed. Now everyone working in the field, not just the BMY scientists, wants to understand why.

Results like this illustrate the limits of our current knowledge.]]>

As an example, our knowledge to date about PD-1/PD-L1 inhibition led biotech/pharma professionals, like myself, to assume that CM-026 would be a positive study. Unfortunately the trial failed. Now everyone working in the field, not just the BMY scientists, wants to understand why.

Results like this illustrate the limits of our current knowledge.]]>

Just to be clear, I am long BMY for a long time. I continue to hold for now, but folks to think about the new reality in this particular space.]]>

Just to be clear, I am long BMY for a long time. I continue to hold for now, but folks to think about the new reality in this particular space.]]>

Rest assured that BMY has already performed what is called a retrospective analysis ("looking backward") to do as you suggest (this again is an assumption) and that they are currently trying to understand these results and determine next steps.

The problem at the moment for BMY is that even if they find a sub-cohort that responded to the treatment (for argument, let's say those with greater than or equal to 20% of their cancer cells expressing PD-L1) there are a couple of large hurdles to overcome. 1) The study wasn't designed with enough statistical power to show that a positive result in a sub-cohort would be able to show acceptable statistical confidence, and 2) because of the lack of statistical power the retrospectively determined result would not be acceptable to regulators, like the FDA. This means BMY likely, at the minimum, just bought themselves another large, Phase 3 trial to test Opdivo monotherapy in the correct patient cohort and the associated delay to approval associated with designing, implementing, enrolling, conducting, and filing such a study with regulators (~2-3 years).]]>

Rest assured that BMY has already performed what is called a retrospective analysis ("looking backward") to do as you suggest (this again is an assumption) and that they are currently trying to understand these results and determine next steps.

The problem at the moment for BMY is that even if they find a sub-cohort that responded to the treatment (for argument, let's say those with greater than or equal to 20% of their cancer cells expressing PD-L1) there are a couple of large hurdles to overcome. 1) The study wasn't designed with enough statistical power to show that a positive result in a sub-cohort would be able to show acceptable statistical confidence, and 2) because of the lack of statistical power the retrospectively determined result would not be acceptable to regulators, like the FDA. This means BMY likely, at the minimum, just bought themselves another large, Phase 3 trial to test Opdivo monotherapy in the correct patient cohort and the associated delay to approval associated with designing, implementing, enrolling, conducting, and filing such a study with regulators (~2-3 years).]]>