Keytru­da PhI­II fail­ure in gas­tric can­cer blights Mer­ck­'s quest for front­line dom­i­nance

A year and a half af­ter scor­ing an ap­proval to use Keytru­da in third-line gas­tric can­cer, Mer­ck has run in­to a wall try­ing to ap­ply the PD-1 star in the front­line set­ting.

In an up­date for the KEYNOTE-062, the com­pa­ny $MRK dis­closed that Keytru­da as a monother­a­py proved non-in­fe­ri­or to chemother­a­py — the cur­rent stan­dard of care for ad­vanced gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma — in over­all sur­vival. In com­bi­na­tion, though, Keytru­da plus chemo was not found to be su­pe­ri­or for ei­ther OS or pro­gres­sion-free sur­vival com­pared with chemo alone. That like­ly meant more miss­es than hits in the pri­ma­ry end­points, list­ed as PFS and OS on clin­i­cal­tri­als.gov.

As a spokesper­son ex­plained:

Based on the pre-spec­i­fied sta­tis­ti­cal analy­sis plan, su­pe­ri­or­i­ty test­ing for OS in the KEYTRU­DA monother­a­py group was con­duct­ed, how­ev­er as an­nounced, the fi­nal analy­sis showed that KEYTRU­DA monother­a­py was non-in­fe­ri­or, not su­pe­ri­or, to the chemother­a­py arm in pa­tients whose tu­mors were CPS ≥1. For KEYNOTE-062, it made sense to test for non­in­fe­ri­or­i­ty in the event that KEYTRU­DA monother­a­py had com­pa­ra­ble ef­fi­ca­cy as chemother­a­py with a po­ten­tial­ly fa­vor­able safe­ty and tol­er­a­bil­i­ty pro­file.

Roy Baynes

Mer­ck went ahead with the Phase III tri­al de­spite a flop in the sec­ond-line set­ting of the same in­di­ca­tion in 2017. Grant­ed, the drug had pos­i­tive third-line da­ta go­ing for it in a tough dis­ease where Pfiz­er and Mer­ck KGaA’s PD-L1 drug Baven­cio failed.

All pa­tients in the tri­al had tu­mors that ex­press PD-L1. In­ves­ti­ga­tors did not tease out any dif­fer­ences be­tween those with a high com­bined pos­i­tive score (CPS ≥10) and those with low CPS, of 1 or above.

“Gas­tric can­cer is his­tor­i­cal­ly dif­fi­cult to treat, and un­for­tu­nate­ly con­tin­ues to be as­so­ci­at­ed with high mor­tal­i­ty rates in many coun­tries, par­tic­u­lar­ly in the metasta­t­ic stage,” said Roy Baynes, Mer­ck’s head of glob­al de­vel­op­ment, in a state­ment.

The brief state­ment al­so didn’t cov­er any of the sec­ondary end­points, in­clud­ing over­all re­sponse rate, du­ra­tion of re­sponse, qual­i­ty of life and a gas­tric can­cer score.

Mer­ck says it plans to dis­cuss the fi­nal analy­sis with the FDA, as well as oth­er on­go­ing gas­tric stud­ies that might serve as con­fir­ma­to­ry tri­als, in­clud­ing KEYNOTE-811 and KEYNOTE-859. Then there’s the Phase III KEYNOTE-585 to watch, where Keytru­da in com­bi­na­tion with chemother­a­py is test­ed in a neoad­ju­vant/ad­ju­vant set­ting.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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Leo Tarkovsky, Fingerpaint Group's new chief commercial officer

Fin­ger­paint Group taps for­mer WPP and Mc­Cann Health ex­ec for new com­mer­cial role

Healthcare agency veteran Leo Tarkovsky has joined Fingerpaint Group as chief commercial officer to oversee its growing portfolio of pharma and healthcare agencies and communications companies.

Tarkovsky came to Fingerpaint from WPP where he was EVP for global healthcare growth over the past year. Before that served at McCann Health for seven years including as president overseeing the New York agencies with pharma clients including AstraZeneca, Bristol Myers Squibb, Eli Lilly and Johnson & Johnson’s Janssen.

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