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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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