Thursday, January 23, 2014

Nivolumab Vs. MK-3475 -- U.S. Gate Timing Is. . . Everything, Now.

As irony would have it, just about an hour or so after I wrote my latest, at least suggesting that the Merck v. BMS "race to clear the FDA's approval gates" was essentially a dead heat now (< +- 6 months). . .

. . .Up pops a Wall Street analyst (at ISI), suggesting that nivolumab (the BMS version) might have hit some snags. I think that is a particularly unfounded guess, on ISI's part. But the sheer breathlessness of it all will help IBD to sell more papers (and ads, online). Here's a bit -- but this first bit is plainly some bird cage liner worthy "analysis":

. . . .The existence of the new trial, however, could mean the data from the nivolumab/Yervoy combo has problems, according to ISI Group analyst Mark Schoenebaum.

"One possibility is that this is not good news, that the data from Checkmate 012 indicate the combo of the two drugs is not sufficiently effective or is excessively toxic in NSCLC," he wrote in an email to clients. "Another possibility is that by starting the new phase-three trial BMY is instead being strategic, perhaps knowing that optimizing the dose for the combo may take time and/or not wanting to put its lead position in NSCLC at risk with others studying their PD1/PDL1 antibody specifically in PDL1+ patients."

The new study adds a further complication to the PD-1 saga, which took a surprising turn last week when Merck (MRK) said it would begin the submission process for its own anti-PD-1 for melanoma, even though Bristol-Myers was generally expected to file first. . . .

As I say, that first paragraph of analysis seems rather overwrought. It is far more likely (in my experienced view) that BMS wants to begin now, to get the actual data to fine tune dosages -- and doesn't mind spending a big chunk of cash to do so (using a new Phase III study -- with an "almost guaranteed" mega blockbuster status, for nivolumab). This would all be aimed at shortening the at least six month burn-in/uptake process with US oncologists, as it flies out of the FDA gating area. But that goofy ISI spin above will sell papers for Investors' Business Daily, no doubt. We will keep you posted.

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