Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bris­tol My­ers Squibb and its check­point in­hibitor Op­di­vo af­ter set­backs in lung and brain can­cers. But in the bat­tle against Mer­ck’s Keytru­da, any suc­cess mat­ters — and now Bris­tol could be look­ing at a quick ap­proval for Op­di­vo in an un­matched in­di­ca­tion.

The FDA will launch a speedy re­view of a com­bi­na­tion of Bris­tol My­ers Squibb’s Op­di­vo and chemother­a­py to treat first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma, the drug­mak­er said Wednes­day. The agency set an ac­tion date of May 25 for the ap­pli­ca­tion.

Earn­ing a nod in those ear­ly pa­tients would be a clear leg up on Mer­ck’s su­per­star check­point in­hibitor Keytru­da, which sports an ap­proval in third-line pa­tients with the PD-(L)1 bio­mark­er dat­ing back to Sep­tem­ber 2017 but has since flopped con­fir­ma­to­ry tri­als in first- and sec­ond-line use.

The FDA will base its re­view on da­ta from the Phase III Check­mate-649 study, which showed the Op­di­vo-chemo com­bo sig­nif­i­cant­ly ex­tend­ed pa­tients’ lives over­all and stopped the pro­gres­sion of their dis­ease over chemo alone. Ad­vanced gas­tric can­cer is a no­to­ri­ous­ly dif­fi­cult-to-treat con­di­tion with a poor prog­no­sis, with rough­ly 738,000 deaths world­wide tied to the dis­ease in 2018.

Tak­ing the lead in stom­ach can­cer would do won­ders in Op­di­vo’s ex­is­ten­tial bat­tle with Keytru­da for the check­point in­hibitor, es­pe­cial­ly af­ter a se­ries of sting­ing set­backs in re­cent months.

In De­cem­ber, Bris­tol walked on Op­di­vo’s third-line-or-lat­er FDA ap­proval for small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod in that in­di­ca­tion back in 2018 failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. Based on find­ings from its Check­mate-451 and -331 tri­als, which found Op­di­vo failed to hit its OS pri­ma­ry end­points as both a monother­a­py and com­bo treat­ment with Yer­voy, Bris­tol de­cid­ed to pull its ap­proval based on the FDA’s rec­om­men­da­tions to fol­low post-mar­ket­ing sci­ence.

In 2018, an Op­di­vo/Yer­voy com­bo missed the pri­ma­ry end­point for over­all sur­vival in Check­mate-451, where the meds were be­ing eval­u­at­ed as main­te­nance ther­a­py for SCLC, fol­low­ing an ini­tial round of chemother­a­py. The re­sults came just over a month af­ter the drug­mak­er un­veiled an Op­di­vo flop in the Check­mate-331 study, which test­ed the im­munother­a­py against the sec­ond-line SCLC stan­dard-of-care.

Just a week be­fore that, Bris­tol opt­ed to for­go its chances in brain can­cer glioblas­toma, an­oth­er chron­i­cal­ly dif­fi­cult-to-treat in­di­ca­tion, fol­low­ing mul­ti­ple clin­i­cal fails. The drug­mak­er ad­mit­ted a com­bo of Op­di­vo on top of stan­dard-of-care temo­zolo­mide plus ra­di­a­tion couldn’t beat place­bo in ex­tend­ing over­all sur­vival in pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme who pre­vi­ous­ly had their tu­mor sur­gi­cal­ly re­moved.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serves, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.