Thursday, May 11, 2017

Two Bits Of Good News For Kenilworth... (Short Supply) Wee Hours Edition

We first mentioned this idea last year -- that these Merck approvals will always be about 25 per cent of the addressable patient base, in lung cancers. That was when Merck first got this indication approval as a mono-therapy.

And as of market close last night, Kenilworth now has it -- in combination with chemo. That's good news -- but may not be as important as some analysts believe -- as it covers about the same subset (i.e., about one-quarter of all such patients) that Merck has been battling BMS and Roche over, for most of the prior twelve months. But it is good news, to be sure. [Something we've found in very short supply of late, truth told.]

Separately, Merck disclosed in the SEC Form 10-Q (pages 18 and 19) filed this week that it has, as of this month, settled the Cabilly patent spats (see my prior backgrounder, here, and graphic -- at right), related to pembrolizumab -- for an immaterial sum. That too is good news.

On the main topic, though -- here's the lung cancer FiercePharma chemo-combo FDA approval story, and a bit:

. . . .The FDA late Wednesday green-lighted Merck’s checkpoint inhibitor Keytruda in tandem with Eli Lilly’s Alimta as a regimen for previously untreated patients with non-squamous non-small cell lung cancer.

Keytruda’s solo approval in previously untreated patients covers only those with PD-L1 expression levels above 50%, and that group makes up just 25% to 30% of the addressable population. . . .

Merck’s approval also marks “the first true endorsement of the general ‘chemo combo’ approach,” which Roche is also pursuing with its contender Tecentriq. What is “not yet clear” is how Bristol-Myers and AstraZeneca’s efforts to pair their PD-1/PD-L1 meds with CTLA4 treatments—such as BMS' own Yervoy—will stack up. . . .

We didn't bite on the "next seven days" making or breaking Merck's year stories out of Wall Street, last week -- for just this reason.

And so. . . for reasons well-understood, over much of these past four and one half years -- it just seems that sleep will not find me once again, this evening/morning. . . so I wait for the luminous and clear. . . arrival of a new dawn.

For as I well-know, this too, shall pass. . . all things, good and bad, sweetly sublime, and profoundly cruel, too. . . do end.


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