As Widely Expected, Merck Gets Another Keytruda® Nod, From FDA, This Time In Blood Cancer…
March 15, 2017

As a counterweight to this rather downbeat story of last night, Kenilworth overnight announced an expected nod for Hodgkin’s lymphoma — handed down by FDA. BMS’s Opdivo® long ago received a similar indication approval, from FDA. [Legacy graphic at right; story here, from as early as December 2014.]

This is very good news, albeit in a not terribly high burden cancer. It is priced in to the NYSE trading, to be sure. Here’s a bit, from PharmaTimes:

. . . .Approval of the anti-PD1 therapy, the first for the drug in a blood cancer, “reinforces the hope that immunotherapy will prove useful in a wide variety of cancers,” noted Dr Roger M. Perlmutter, president of Merck Research Laboratories. . . .

“For the patients with classical Hodgkin lymphoma who are not cured with existing treatments, there are limited options, and treating their disease becomes more challenging,” added Dr Craig Moskowitz, clinical director, division of haematologic oncology, Memorial Sloan Kettering Cancer Center. “This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us the opportunity to help patients in their fight against this devastating disease. . . .”

Now you know. Big judicial branch constitutional events due up, later today, out of Hawaii — as it all portends to reinvigorate, and return the nation — to her nearly three centuries’ long steady march, toward true pluralism. This will be the beginning of the end, for Trump’s year of ugliness, on this score. Amendment, First — means just what it says.


At ASH, BMS’s Opdivo® (Nivolumab) Outshines Merck’s Keytruda® (Pembrolizumab) In Hodgkin’s Lymphoma
December 6, 2014

It is still pretty early-on, in these particular clinical trial processes, and only partial results are available from the ongoing trials (i.e., not remotely complete) — so the data sets are smallish — and, I suppose, in fairness — they could reverse, as the deeper results sets are tallied. But on the current partial results at ASH, this weekend, it looks like nivolumab, branded as Opdivo® by BMS, is pulling away from Merck’s Keytruda®. Both are broad-acting anti PD-1 oncology agents. Both have shown revolutionary effectiveness in a surprisingly wide range of cancers. But nivolumab may be showing more robust efficacy here, just as we predicted about a half-year ago, now.

In any event, here’s the erstwhile John Carroll’s take, for FierceBiotech, on the ground in San Francisco, at ASH:

. . . .Bristol-Myers’ Opdivo could start breaking away from Merck’s drug with better efficacy results. Bristol has achieved an 87% response rate in an early Hodgkin lymphoma study of its own. . . .

For Bristol-Myers’ Opdivo (nivolumab, the 87% response rate broke down into a 17% complete response rate with 70% achieving a partial response. 13% experienced stable disease. “Of the patients who achieved a complete and partial response, 60% (n=12) had their first response within eight weeks (range: 3-39 weeks), investigators reported. “Data from the study also showed a progression-free survival rate of 86% at 24 weeks, meaning patients lived six months longer without their disease worsening. . . .”

Obviously, there are a range of studies — on other cancers — underway. So the results will be manifold, in the coming months, but we will stick with our prediction that BMS wins the day, here. A great evening up north here, to stay warm by the fire. . . so I will. . . .