Acceptance of an additional regulatory filing is normally a footnote. The exception to this rule is Merck & Co. (NYSE:MRK), whose market cap this morning gained an incredible $8bn on news that the FDA had accepted for review an application to use Keytruda plus chemotherapy in first-line lung cancer.
Then again, this is the first direct evidence of the group taking on Bristol-Myers Squibb (NYSE:BMY) in the combination setting. True, Merck was known to have been pursuing the chemo combo approach – it had tried and failed to get it listed in US compendia based on the uncontrolled Phase II Keynote-021 trial – but the market had until now assumed that it would wait for Phase III data before filing.
Bristol’s valuation lost $2.7bn this morning. Since Bristol’s Opdivo failed in the first-line setting, all the big immuno-oncology players have upped their game in a bid to take on Keytruda, which is approved first-line albeit only in PD-L1-high patients (Three imminent second chances in first-line lung cancer, January 5, 2017).
