This morning, Bloomberg is reporting that Merck’s enrolling of a Phase II study on MK-3475, lambrolizumab (so named, as a dig at the most likely beneficiaries of the drug: gold-chain wearing, pot-bellied, high-multi-millionaire net-worth “Lamborghini-Lizards species” — at risk of melanoma, due to their penchant for flashy top-down driving!. . . where was I? Oh, right.), may turn out to be bigger than just the usual science backgrounder news it appears to be at first blush.
Because, at 500 patients, and with breakthrough status at FDA — the Phase II 500 patient data just might be a large enough “n” to grant approvability, on that Phase II study, alone. IF the FDA accepts that argument, and that data is clearly, and appropriately powered, to demonstrate strong efficacy and safety. . . then Merck is essentially tied with BMS, and its nivolumab candidate, on timing. [As I had reported last month, Merck was about a year behind BMS, because Merck’s initial safety study was too small to support direct NDA submission. It seems that is changing.]
This is materially good news for Merck. We will see if it moves the stock price on the NYSE.
Here is a snip, from the Bloomberg item — do go read it all:
. . . .Merck, of Whitehouse Station, New Jersey, is in second-stage testing on its immune therapy, lambrolizumab, in melanoma. If successful, the 500-patient trial may be large enough to gain approval from U.S. regulators without completing the usual required third-stage of testing, putting it in a virtual dead heat with Bristol’s nivolumab in melanoma. . . .
We will keep the readership posted. PS: I’ve updated the graphic — to include the MRL science crew’s nomenclature joke, for MK-3475. It’s the target, indeed!