'Go­ing big': Mer­ck launch­es front­line PhI­II lung can­cer study for Keytru­da/Yer­voy com­bo

Mer­ck took a dom­i­nant po­si­tion in front­line lung can­cer with the ap­proval of a com­bi­na­tion of Keytru­da and chemo. And it isn’t just wait­ing around to see if any com­bi­na­tion of a PD-(L)1 with a CT­LA4 can come along and knock it off its mar­ket-lead­ing perch.

The phar­ma gi­ant has launched a Phase III study com­bin­ing its check­point star with the Bris­tol-My­ers drug. Re­searchers are re­cruit­ing 548 pa­tients at sites around the world, ac­cord­ing to the list­ing at clin­i­cal­tri­als.gov.

The ju­ry is still def­i­nite­ly out on how a PD-(L)1/CT­LA-4 com­bo will work. Yer­voy and its class has been ef­fec­tive in im­prov­ing sur­vival rates, but they’re al­so as­so­ci­at­ed with sig­nif­i­cant tox­i­c­i­ty, which makes their use prob­lem­at­ic.

Mer­ck al­so has its own CT­LA-4 (MK-1308), which it is com­bin­ing with Keytru­da. So why add Yer­voy to the mix?

The sim­plest ex­pla­na­tion may be that Mer­ck, which has hun­dreds of com­bo stud­ies un­der­way, is try­ing every­thing. It’s al­so been spurred on by Bern­stein’s Tim An­der­son.

Since 2016, we have ar­gued it would be wise for MRK to run com­bi­na­tion tri­als of Keytru­da+Yer­voy tri­al in 1L lung can­cer.  Even though MRK does not own Yer­voy, it could still eas­i­ly de­sign a study like this, and it would be a hedge against the pos­si­bil­i­ty that AZN’s MYS­TIC and BMY’s Check­mate-227 show that CT­LA4+PDx com­bi­na­tion ther­a­py is vi­able (its vi­a­bil­i­ty re­mains un­clear at the mo­ment).

MYS­TIC, of course, has proven to be some­thing of an em­bar­rass­ment to As­traZeneca so far, with dur­val­um­ab and treme­li­mum­ab miss­ing the first goal on pro­gres­sion-free sur­vival. They’re still shoot­ing for over­all sur­vival, though, and aren’t com­plete­ly count­ed out in a field that rou­tine­ly pro­vides ex­tra­or­di­nary sur­pris­es.

An­der­son has urged Mer­ck to “go big or go home” on this front. I have no idea what Mer­ck, which went big on Keytru­da sev­er­al years ago, thought of that. But An­der­son has some in­flu­ence here and is not to be ig­nored.

The tri­al will on­ly en­roll high PDL1 ex­pressers (>50%), and bold­ly, it will com­pare this com­bi­na­tion to Keytru­da monother­a­py (which has be­come stan­dard of care any­way; re­call that MYS­TIC and ‘227 don’t have a PDx as a com­para­tor, but on­ly con­ven­tion­al chemother­a­py). The pri­ma­ry end­points are PFS and OS, but re­sults won’t be in hand un­til 2022 per clin­i­cal­tri­als.gov (link); this time­line is ar­guably con­ser­v­a­tive.

Bris­tol-My­ers and Cy­tomX, mean­while, are work­ing on a new CT­LA-4 that they hope will prove just as ef­fi­ca­cious or more while sig­nif­i­cant­ly less tox­ic.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.

As an­oth­er an­tibi­otics biotech sinks in­to a cri­sis, warn­ings of a sec­tor ‘col­lapse’

Another antibiotics company is scrambling to survive today, forcing the company’s founding CEO to exit in a reorganization that eliminates its research capabilities as the survivors look to improve on minuscule sales of their newly approved treatment. And the news — on top of an alarming series of failures — spurred at least one figure in the field to warn of a looming collapse of the antimicrobial resistance research field.

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