Pfiz­er, Mer­ck KGaA run in­to a se­vere set­back as PD-L1 drug Baven­cio fails in PhI­II gas­tric can­cer study

Pfiz­er $PFE and its part­ner Mer­ck KGaA have run in­to a dead end in their race to ex­pand the mar­ket for their PD-L1 check­point Baven­cio (avelum­ab). Re­searchers to­day con­ced­ed that the check­point — one of 5 now scram­bling to ex­pand their mar­ket turf in the mega-block­buster glob­al on­col­o­gy busi­ness — failed to sig­nif­i­cant­ly im­prove over­all sur­vival for ad­vanced gas­tric can­cer pa­tients com­pared to best stan­dard of care.

We won’t see the da­ta un­til a lat­er sci­en­tif­ic con­fer­ence to be de­cid­ed on, but the JAVELIN Gas­tric 300 flop will put a def­i­nite hitch in their plans to ex­pand sales for a key drug in both com­pa­nies’ pipelines.

Lu­ciano Ros­set­ti, Mer­ck KGaA

Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti put the fail­ure down to their de­ci­sion to test the drug against cur­rent­ly used chemo rather than a place­bo. He not­ed:

“Gas­tric can­cer in the third-line set­ting is a par­tic­u­lar­ly hard-to-treat and het­ero­ge­neous dis­ease, and im­por­tant­ly, this was the first tri­al con­duct­ed with a check­point in­hibitor com­pared to an ac­tive chemother­a­py com­para­tor rather than place­bo in a glob­al pa­tient pop­u­la­tion.”

The tri­al en­rolled 371 pa­tients from 147 sites in Asia, Aus­tralia, Eu­rope, North Amer­i­ca and South Amer­i­ca. Gas­tric can­cer counts as the third most com­mon type of can­cer killer.

Their mis­for­tune is US Mer­ck’s gain, as well as Bris­tol-My­ers Squibb’s, which both earned third-line ap­provals af­ter test­ing their drugs against a place­bo.

Mer­ck gained an ac­cel­er­at­ed OK from the FDA two months ago to use Keytru­da, a PD-1 check­point, against ad­vanced gas­tric can­cer af­ter lay­ing out mar­gin­al­ly suc­cess­ful re­sponse rates for pa­tients whose tu­mors hit the mark on PD-L1 ex­pres­sion. And af­ter look­ing over the da­ta on over­all sur­vival for both ap­proved ther­a­pies, Uber Raf­fat at Ever­core ISI con­clud­ed that Pfiz­er and Mer­ck KGaA faced tough odds from the start.

And the fail­ure rais­es an­oth­er is­sue, he says:

Im­me­di­ate­ly makes you won­der: is avelum­ab in­fe­ri­or on ef­fi­ca­cy?  And does this tie in­to the broad­er PDL1 vs PD1 de­bate?

That de­bate cen­ters on a heat­ed dis­cus­sion of whether PD-L1 is in­her­ent­ly weak­er than PD-1, so you can ex­pect to hear lots more about it.

This set­back for Pfiz­er and Mer­ck KGaA al­so un­der­scores the se­ries of stun­ning sur­pris­es that con­tin­ues to ad­vance some play­ers while oth­ers are held back. Check­points, which re­moves a brake on an im­mune sys­tem re­sponse to can­cer cells, are fast en­ter­ing the stan­dard of care in a wide range of on­col­o­gy mar­kets, both as a so­lo ther­a­py as well as in com­bi­na­tion. And there’s been a fren­zied race to field new check­points, as we high­light in this re­cent piece not­ing 50 PD-1/L1 ther­a­pies in the clin­ic and 114 more in pre­clin­i­cal de­vel­op­ment.

Still in the pipeline is a Phase III study — JAVELIN Gas­tric 100 — which is test­ing the check­point as a front­line ther­a­py for gas­tric can­cer.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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