16544
Fwd: BMY: lung cancer trial update
Begin forwarded message:
From: "Umer Raffat" <umer.raffat@evercoreisi.com>
Date: September 3, 2018 at 14:25:06 EDT
To: "sally@icarusconsultants.com" <sally@icarusconsultants.com>
Subject: BMY: lung cancer trial update
Reply-To: "Umer Raffat"<umer.raffat@evercoreisi.com>
Checkmate-9LA is a v impt 1L lung study underway for BMY (due 2H:19). Unlike CKM-227 (investigating PD1+CTLA4), CKM-9LA has 2 rounds of chemo along with PD1+CTLA4 combo … the idea being that the chemo induction may help with early progressers (recall ipi+nivo underperforms chemo on PFS in the first 3-4 mo).
It appears that Checkmate-9LA has had some stat changes recently … the exact nature of which is not fully disclosed.
Here’s what we’re seeing:
- Clinicaltrials.gov is now showing that the sample size of CKM-9LA has been increased from 420 pts to 700.
- On the 2Q earnings call in July, BMY’s Tom Lynch hinted: “accrual has gone from about 500 patients to about 700 patients”
This change obviously increases the power of the trial.
Question is: why would BMY decide to do that all of a sudden?
It’s our understanding that the the primary motivation behind this change may have been to add statistical optionality. I can say that with confidence because BMY dropped a hint on 1Q call regarding potential for optionality on stat plan:
we’re not going to comment on the physical plan of CheckMate-9LA at this point. As you know, we have committed to collecting TMB in this patient population, and we look forward to seeing how TMB plays out in this patient population. We have announced that overall survival will be an important endpoint in CheckMate-9LA. But as you know, we do have optionality regarding and around that statistical plan as we move forward.
But what exactly would this “statistical optionality” mean?
It’s impossible to say with certainty … but here’s a theory: we noticed that the primary endpoint remains OS. However, we also know that there was a secondary endpoint for OS specifically in patients with certain tumor mutation burden threshold. Perhaps this increase in sample size added statistical optionality around taking a primary endpoint read in a sub-population (TMB+). But again, that’s my theory – and certainly not confirmed with the company.
For reference, notice how a BMY slide at a broker conference this year described the key populations in CKM-9LA, and notice the PDL1 and TMB selection optionalities:
You may ask: is timing also pushed out?
Doesn’t seem like it.
BMY previously mentioned CKM-9LA should report by 2H:19.
We also noticed that BMY gave an update on enrollment timelines (500 pts already enrolled as of of July 2018 earnings call) … and more importantly, BMY reiterated “end of next year” timing on that call.

Last point, don’t forget that CKM-227’s Part 2 is fully enrolled and has NOT reported out yet … that’s the PD1+chemo trial (no PD1+CTLA4 in part 2) – am pasting the trial design below to jog our memory:
Exhibit: BMY’s Checkmate-227
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september 2018
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