Trad­ing places with Bris­tol-My­ers, Mer­ck hit with an­oth­er late-stage set­back on check­point star Keytru­da

Close to a year af­ter Mer­ck $MRK won an ac­cel­er­at­ed FDA OK to use its PD-1 check­point star Keytru­da for treat­ing sec­ond-line cas­es head and neck squa­mous cell car­ci­no­ma in com­bi­na­tion with plat­inum-con­tain­ing chemo, the phar­ma gi­ant an­nounced that its big Phase III study for that in­di­ca­tion failed.

The piv­otal KEYNOTE-040 tri­al failed to meet the pri­ma­ry end­point on over­all sur­vival in com­par­ing the block­buster check­point against stan­dard ther­a­pies, the phar­ma gi­ant re­port­ed. But the cur­rent ap­proval stands nev­er­the­less, Mer­ck said in a state­ment.

“The com­pa­ny not­ed that the FDA re­mains com­fort­able with the drug’s cur­rent ac­cel­er­at­ed ap­proval in this in­di­ca­tion de­spite the tri­al re­sults,” ob­served Leerink’s Sea­mus Fer­nan­dez. “Im­por­tant­ly, Keytru­da ap­pears to have an­oth­er shot on goal for full ap­proval in H&N can­cer, as the Keynote-048 study in first-line pa­tients could, if pos­i­tive, serve as the con­fir­ma­to­ry tri­al.”

Roger Perl­mut­ter, Mer­ck

Mer­ck didn’t pro­vide a lot of de­tails, but this is the lat­est in a se­ries of set­backs in the field that have be­gun to show the out­er lim­its of ef­fi­ca­cy for a new class of can­cer med that has trans­formed on­col­o­gy ther­a­py in the past two years. But right now, those out­er lim­its of ef­fi­ca­cy run along a blur­ry line, with no clear ex­pla­na­tions for what is caus­ing these sud­den break­downs.

Mer­ck re­cent­ly was forced to put a slate of 3 Keytru­da tri­als for mul­ti­ple myelo­ma on hold af­ter in­ves­ti­ga­tors spot­ted a high­er rate of death in the check­point arm. Two of those stud­ies used com­bi­na­tions with Cel­gene drugs, Po­m­a­lyst and its big drug Revlim­id.

Mer­ck has ini­ti­at­ed hun­dreds of stud­ies, in­clud­ing some 300 com­bi­na­tion stud­ies, as it races to cap­i­tal­ize on its new lead in the field af­ter Bris­tol-My­ers Squibb ran in­to se­ri­ous is­sues with a failed study for lung can­cer. It’s clear that af­ter see­ing some re­mark­able im­prove­ments for a sig­nif­i­cant mi­nor­i­ty of check­point pa­tients, these ther­a­pies have their lim­its. Roche has al­so had its own prob­lems with the fail­ure of a Phase III con­fir­ma­to­ry study us­ing Tecen­triq.

Bris­tol-My­ers’ Op­di­vo, mean­while, post­ed pos­i­tive Phase III da­ta on squa­mous cell car­ci­no­ma of the head and neck back in late 2016, with a me­di­an OS of 7.5 months for Op­di­vo com­pared to 5.1 months for in­ves­ti­ga­tor’s choice.

What to make of that?

“Up un­til yes­ter­day,” not­ed Ever­core ISI’s Umer Raf­fat, “I would have told you that there are at least 2 dif­fer­ent in­di­ca­tions where MRK worked and oth­ers failed … and per­haps MRK is just ex­e­cut­ing these tri­als much bet­ter.  How­ev­er, as of to­day, there ap­pears to be no con­sis­ten­cy in the in­con­sis­ten­cy.  Now MRK failed where BMY worked.”

“We are en­cour­aged by the pos­i­tive im­pact that KEYTRU­DA has had on many can­cer pa­tients, in­clud­ing those with pre­vi­ous­ly treat­ed re­cur­rent or metasta­t­ic head and neck can­cer, and we re­main con­fi­dent that KEYTRU­DA is an im­por­tant ther­a­py for this dif­fi­cult-to-treat can­cer,” said Roger Dansey, late-stage on­col­o­gy de­vel­op­ment leader, Mer­ck Re­search Lab­o­ra­to­ries. “We look for­ward to shar­ing the com­pre­hen­sive da­ta analy­sis from KEYNOTE-040 with the sci­en­tif­ic com­mu­ni­ty at an up­com­ing med­ical meet­ing.”

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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