Bris­tol-My­ers’ tar­nished check­point star Op­di­vo beats out Yer­voy in sur­prise PhI­II

Bris­tol-My­ers got a much-need­ed boost with the ear­li­er-than-ex­pect­ed news that Op­di­vo beat out Yer­voy in a Phase III study fo­cused on a par­tic­u­lar niche for ad­ju­vant melanoma ther­a­py. And an an­a­lyst who’s been fol­low­ing the da­ta says it could be worth a bil­lion dol­lars in added an­nu­al sales.

The big biotech says an in­ter­im analy­sis of Check­mate-238 pro­vid­ed re­searchers with proof that the PD-1 drug out­per­formed Yer­voy, Bris­tol-My­ers’ CT­LA-4 drug, among ad­vanced Stage II­Ib or IV pa­tients, cut­ting the re­cur­rence rate for those who have un­der­gone surgery. There are no bot­tom line num­bers in the state­ment, but Bris­tol-My­ers says they’ll be able to re­lease da­ta at an up­com­ing con­fer­ence to show that Op­di­vo pro­vid­ed a sig­nif­i­cant­ly low­er risk of dis­ease re­cur­rence.

Sea­mus Fer­nan­dez notes that the re­sults are like­ly to can­ni­bal­ize Bris­tol’s Yer­voy rev­enue, but will like­ly de­liv­er a $1 bil­lion boost to Op­di­vo as physi­cians steer away from the high­er dos­es of high­ly tox­ic Yer­voy. He not­ed:

This comes as a sur­prise, as top-line da­ta were not ex­pect­ed un­til the fi­nal read­out in 2H:18. While there were no de­tails in the press re­lease re­gard­ing the mag­ni­tude of ben­e­fit for Op­di­vo, we would ex­pect it to be­come the stan­dard of care in high-risk pa­tients fol­low­ing sur­gi­cal re­sec­tion giv­en its su­pe­ri­or safe­ty and tol­er­a­bil­i­ty pro­file rel­a­tive to Yer­voy. We es­ti­mate the ad­ju­vant melanoma mar­ket will ex­pand PD1 sales by ap­prox­i­mate­ly $3B glob­al­ly. Al­though this like­ly will can­ni­bal­ize sales of Yer­voy in the set­ting (we es­ti­mate cur­rent ad­ju­vant Yer­voy sales at $300-400M), the ex­pan­sion of the mar­ket should add ap­prox­i­mate­ly $1B to BMY’s net im­muno-on­col­o­gy (IO) sales de­spite as­sumed com­pe­ti­tion from MRK’s (MP) Keytru­da (pem­brolizum­ab; an­ti-PD-1).

Vic­ki Good­man

Op­di­vo’s rocky road at Bris­tol has led to end­less spec­u­la­tion that the com­pa­ny could find it­self on the auc­tion block be­fore it gets a chance to re­or­ga­nize in the clin­ic and come back in its head-to-head show­down with Mer­ck’s Keytru­da. But it is al­so rack­ing up bil­lions in an­nu­al sales of Op­di­vo, with a slate of new tri­als un­der­way.

“These topline re­sults sup­port the po­ten­tial promise of Op­di­vo as a treat­ment op­tion for pa­tients with high-risk sur­gi­cal­ly re­sect­ed melanoma. There re­mains an un­met need for ad­di­tion­al op­tions as the ma­jor­i­ty of stage III and re­sect­ed stage IV high-risk melanoma pa­tients ex­pe­ri­ence dis­ease re­cur­rence af­ter surgery,” said Vic­ki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-My­ers Squibb. “We are com­mit­ted to re­search­ing ther­a­pies that may bet­ter meet the needs of this pa­tient pop­u­la­tion and look for­ward to shar­ing these da­ta with health au­thor­i­ties soon.”

Jef­frey We­ber

Physi­cians in the field, in­clud­ing the high pro­file Jef­frey We­ber at NYU Lan­gone, have been wait­ing to see how this one will shake out. And they’re get­ting the read­out a year ahead of sched­ule. In a pan­el chat with ex­perts in the field in the spring of 2016, he not­ed:

On the ba­sis of my own ex­pe­ri­ence with both drugs in pi­lot ad­ju­vant tri­als, I have a sus­pi­cion that nivolum­ab is go­ing to look bet­ter than ip­il­i­mum­ab. And the next fron­tier is what we’ve al­ready pi­lot­ed when I was at Mof­fitt and we’ll con­tin­ue at NYU, which is com­bi­na­tion ad­ju­vant ther­a­py. But be­cause of the tox­i­c­i­ty, we flipped the dos­es giv­ing one of ip­il­i­mum­ab and three of nivolum­ab, which is very well-tol­er­at­ed with a pret­ty good track record, ad­mit­ted­ly, in a small study. So, I think that we’ve gone from in­ter­fer­on, we’ll go to ip­il­i­mum­ab, we’ll go to nivolum­ab, and even­tu­al­ly end up at ip­il­i­mum­ab plus nivolum­ab, over the next five years, which brings us to where we’re go­ing in metasta­t­ic treat­ment. I think we’re go­ing to see triple com­bi­na­tions. On the one hand, it’s sci­en­tif­i­cal­ly fas­ci­nat­ing, ex­treme­ly com­plex with para­dox­i­cal­ly a bar that’s now so high, it’s go­ing to be very dif­fi­cult to get com­bi­na­tions ap­proved. You’re go­ing to need to see ma­jor in­cre­men­tal ad­van­tages, which I think you prob­a­bly will see with some of the drugs my col­leagues have men­tioned. But they’re al­so go­ing to be very ex­pen­sive, so phar­ma­coeco­nom­ics is al­so go­ing to play a huge role in what we do. Right now, I would es­ti­mate that the cost of ip­il­i­mum­ab plus nivolum­ab ther­a­py for a year is about $250,000. So, I would ask where does this all end?

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.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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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.