Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

The OS rate on Op­di­vo fell well short of sta­tis­ti­cal sig­nif­i­cance, with a p val­ue of 0.0752. We’ll have to wait for an up­com­ing sci­ence con­fer­ence to get the full pic­ture.

Bris­tol-My­ers shares $BMY were down 4.5% ahead of the open­ing bell Mon­day as in­vestors re­act­ed to the news that the com­pa­ny is sell­ing Ote­zla to sat­is­fy reg­u­la­tors ahead of its big Cel­gene buy­out.

Re­searchers looked for a sil­ver lin­ing in the lat­est cut of the da­ta onOp­di­vo, say­ing “the re­sults showed a clear trend to­wards im­prove­ment in OS for pa­tients treat­ed with Op­di­vo com­pared to so­rafenib (Nex­avar), a cur­rent stan­dard of care.”

Bruno San­gro Clíni­ca Uni­ver­si­dad de Navar­ra

“We are en­cour­aged by the promis­ing ef­fi­ca­cy and safe­ty trends seen with Op­di­vo in Check­Mate-459, es­pe­cial­ly as HCC is a dev­as­tat­ing and dif­fi­cult-to-treat can­cer, for which there have been no sig­nif­i­cant ad­vances over so­rafenib, a stan­dard treat­ment, in more than a decade,” said Bruno San­gro, head of the liv­er unit, Clíni­ca Uni­ver­si­dad de Navar­ra, Pam­plona, Spain.

But an­a­lysts saw the down­side clear­ly. Vamil Di­van from Cred­it­Su­isse not­ed: “While the tri­al showed a trend to­wards an over­all sur­vival ben­e­fit, the lack of sta­tis­ti­cal sig­nif­i­cance opens the door for com­peti­tors such as Mer­ck, Roche and As­tra to be­come the dom­i­nant play­er(s) in this in­di­ca­tion with the var­i­ous com­bi­na­tion tri­als they are cur­rent­ly run­ning.”

Michael Schmidt at SVB Leerink re­cent­ly not­ed:

In the US, Op­di­vo is gain­ing rapid mar­ket share in 2nd line HCC dri­ven by an ag­gres­sive mar­ket­ing ef­fort by BMY and mas­sive free sam­pling with some off-la­bel use not­ed in front-line pa­tients which is sup­port­ed by strong CM-040 re­sults. In Eu­rope, re­go­rafenib is ex­pect­ed to re­main the pre­ferred 2nd line agent in the near term, giv­en dif­fer­ences in treat­ment pat­tern and pref­er­ences.

Bris­tol-My­ers is by no means fin­ished here, with more re­sults ex­pect­ed on their com­bo with the CT­LA-4 Yer­voy. That match-up, though, has al­ready failed in small cell lung can­cer while in­ves­ti­ga­tors have had to deal with a strong push­back from the FDA in their quest to use high tu­mor mu­ta­tion­al bur­den de­f­i­n­i­tions to de­fine a new ap­proach to iden­ti­fy­ing lung can­cer pa­tients most like­ly to re­spond to Op­di­vo.

Mer­ck, mean­while, has fa­mous­ly pressed ahead in its suc­cess­ful dri­ve to gain the lead po­si­tion in the race to com­mand the PD-1 field. Both Keytru­da and Op­di­vo, though, are ex­pect­ed to re­main the two dom­i­nant drugs in their field for some time.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

As new C. diff treat­ments prep for mar­ket, spe­cial­ists di­vid­ed on 'poop in a pil­l' or small mol­e­cule, study finds

What do physicians think about the emerging market for recurrent C. diff? That depends on who you talk to, especially which specialists you talk to.

Fecal microbiota transplants, or FMT, are favored by gastroenterologists familiar with them, while infectious disease doctors prefer traditional small molecule therapies, according to a recent future market evaluation by Spherix Global Insights. While current FMT involves transplanting healthy stool into a C. diff patient through a colonoscopy, FMT encapsulated microbiome pills that are swallowed – referred to by doctors as “poop in a pill” in Spherix’s interviews – are likely on the way to market.

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Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.

Per­pet­u­al cri­sis? Phar­ma com­mu­ni­ca­tions and pub­lic re­la­tions pros just wait for the next shoe to drop

Welcome to pharma public relations where every day feels like it might be a crisis.

More than three-fourths (76%) of pharma communications leaders expect to face three or more crises this year — compared to less than half (49%) of their peers in other industries, according to new survey from risk intelligence company Crisp. The same 76% also expect that a brand new risk that is yet to be identified will crop up this year, compared to 66% of peers across other industries who worry about the same thing.

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