$BMY Back to plan A: CheckMate 227
● Bristol-Myers Squibb (Bristol) issued a press release last night stating that it would not
pursue an accelerated regulatory submission for the combination of its two immunooncology
(IO) drugs, Yervoy and Opdivo, in first-line lung cancer. Non-small cell lung cancer
(NSCLC) is the largest potential indication for IO therapies and is a hotly contested space, so
even small changes to timelines attract scrutiny.
● After the surprise failure of Bristol’s CheckMate 026 trial in 2016, which tested Opdivo as
monotherapy in NSCLC patients, and Merck’s subsequent success with its own similar trial
for Keytruda in the PD-L1 high population, Bristol has been on the back foot.
● The company believes that ultimately, combination IO therapy will deliver the best outcome
for patients, and has good early-stage data to support this hypothesis. However, the key
registrational trial, CheckMate 227, reads out in early 2018, whereas AstraZeneca’s similar
MYSTIC trial should yield progression-free survival (PFS) data in mid-2017.
● Bristol had hinted to investors that there was a possibility of compiling a regulatory
submission from other ongoing studies, which would have meant that they could have
caught up again, but we now know that this will not be the case and investors will once
again be looking to CheckMate 227. AstraZeneca will regain some more breathing space.
● Bristol says that the decision has been based on a review of the data available at the moment
– we do not necessarily believe that this implies anything is “wrong” with the combination
data, given the strength of evidence from earlier work, but nevertheless that the data from
the large CheckMate 227 will be needed to maximise the chances of trial success and product
approval.
● Given Bristol’s fairly narrow therapeutic focus and its changing position in the IO field in
terms of timing and leadership, this news could disappoint the market in the short term, and
further pressure has been applied by the FDA’s acceptance of Merck’s application for the use
of Keytruda + chemotherapy in first-line NSCLC (a different approach, but one that will
compete for the same patients). In the longer term, however, the CheckMate 227 was always
Bristol’s initial plan for a robust investigation into the effects of combination therapy and it
is this on which our forecasts are based.

BERENBERG

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