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.

FDA Oncology Approvals: Why BMS So Ardently Wants Nivolumab To Beat MK-3475 -- By MORE Than Six Months

I've been meaning to post on this for two solid weeks now -- and just haven't found the free thoughtful ten minutes' worth of time. As long as I have a moment over my coffee -- here goes -- even if only half baked(!). (I also finally got around to making a graphic for what will be a series of Condor's predictions/prognostications posts, in various pharmaceutical and bioscience arenas.)

I still think BMS will be on market first (i.e., clear FDA), with nivolumab (my recent backgrounder here) -- the promising Anti-PD-1 cancer candidate -- here in the US. I am just no longer convinced that it will have a six month or more lead, over Merck's MK-3475.

And, since oncologists take a bit to ramp up, a new drug needs more than a six month lead, alone in a given new market, to firmly establish itself as the leader, among the prescribers. Of course, even a later arriving candidate will trump all, if it shows orders of magnitude more efficiacy. But at the moment, BMS and Merck look to be pretty close to parity on clinical trial efficacy and safety.

So -- having the US to oneself for six months or more would be decisive for BMS. (Of course, the same can be said of Merck -- and MK-3475, should it, less probably, garner a six month lead.) We shall see, but MK-3475 is at FDA on a rolling submission now, so they may break from the gate -- at essentially the same moment. And by that, I mean within six months of one another. That will make for a very interesting "off-label" horse race, in other cancers, if both are only initially-approved for melanoma. Now do go read Medicynic, from last summer -- to understand that this is no cure -- from either company.

. . . .This is not a cure but there is clear progress evident with this new drug. Whether this will be sustained remissions with a significant survival benefit, as appears likely, remains to be fully proven.

Medicynical Note: The cost of this new agent will be interesting to track. An unaffordable drug has the same impact as the sound generated by a tree falling in the woods. . . .

More background here -- but I think he is (mostly) wrong on the price notion -- in a good portion of the fully-insured US patient base, at least, as to cancer -- price becomes secondary to significant survival benefits even for the now constrained payers. So -- it should be a fascinating roll-out period, mid-2014. For both companies. How highly will the battling duo be priced, once launched -- at either company? As ever, we shall see.