Bris­tol-My­ers shares sink af­ter an­oth­er set­back for its im­muno-on­col­o­gy fran­chise drugs

Vic­ki Good­man

Once again un­der­min­ing con­fi­dence in its all-im­por­tant im­muno-on­col­o­gy pipeline, Bris­tol-My­ers Squibb con­ced­ed Tues­day evening that a com­bi­na­tion of Op­di­vo and Yer­voy failed to hit a key co-pri­ma­ry end­point in a Phase III study for front­line re­nal cell car­ci­no­ma.

Com­par­ing the com­bo against suni­tinib (Su­tent) in CHECK­MATE-214, re­searchers said that Op­di­vo/Yer­voy failed to sig­nif­i­cant­ly im­prove pro­gres­sion-free sur­vival for pa­tients. They did note, though, that the com­bo hit a co-pri­ma­ry end­point on the ob­jec­tive re­sponse rate, achiev­ing a 41.6% ORR ver­sus 26.5% for suni­tinib. In their words: “The me­di­an PFS was 11.56 months (95% CI 8.71 – 15.51) for the Op­di­vo and Yer­voy com­bi­na­tion ver­sus 8.38 months (95% CI 7.03-10.81) for suni­tinib.”

Com­ing fast on the heels of As­traZeneca’s woe­ful fail­ure on PFS for its PD-L1/CT­LA4 com­bo in lung can­cer, in­vestors clear­ly didn’t like the lat­est set­back for Bris­tol-My­ers, dri­ving shares $BMY down 3.5% in pre-mar­ket trad­ing. In­ves­ti­ga­tors will con­tin­ue to fol­low pa­tients to see how the com­bo works on over­all sur­vival.

An­a­lysts of­fered two key opin­ions on the re­sults. A few not­ed that the PFS num­bers on­ly nar­row­ly missed their tar­get on sta­tis­ti­cal sig­nif­i­cance, mean­ing the com­bo isn’t out for the count. And Michael Schmidt at Leerink not­ed that Ex­elix­is $EX­EL in­vestors are like­ly to be re­lieved as one near-term threat to cabo’s fran­chise for Ex­elix­is at least got de­layed by the late-stage miss.

Un­der­scor­ing that point, Ex­elix­is re­port­ed this morn­ing that it had filed a sup­ple­men­tal NDA for cabo in front­line RCC. Ex­elix­is’ shares jumped 3.5% overnight.

Bris­tol-My­ers has been work­ing hard to over­come sus­pi­cions about the fu­ture of Op­di­vo and I/O in gen­er­al af­ter a ma­jor blow was lev­eled by a fail­ure in front­line lung can­cer. This lat­est flop won’t help, but it al­so won’t de­ter the com­pa­ny from its come­back mis­sion.

“We are en­cour­aged by the to­tal­i­ty of the CHECK­MATE-214 da­ta. The over­all re­sponse rate and dura­bil­i­ty of re­sponse fa­vored the com­bi­na­tion of Op­di­vo and Yer­voy, and the trend for PFS sup­ports the po­ten­tial of the com­bi­na­tion in in­ter­me­di­ate and poor-risk ad­vanced re­nal cell car­ci­no­ma, the most com­mon type of kid­ney can­cer. This is an im­por­tant study in first-line re­nal can­cer as these pa­tients need new op­tions,” said Vic­ki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-My­ers Squibb. “We look for­ward to pre­sent­ing the full re­sults from this study at an up­com­ing med­ical meet­ing.”

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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