Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Mer­ck has worked hard to bring its I/O block­buster Keytru­da in­to ear­li­er and ear­li­er lines of ther­a­py, and now the won­der drug ap­pears poised to make a quick en­try in­to ear­ly ad­vanced cer­vi­cal can­cer.

A com­bi­na­tion of Keytru­da and chemother­a­py with or with­out Roche’s Avastin cut the risk of death by 33% over chemo with or with­out Avastin (p=<0.001) in first-line pa­tients with per­sis­tent, re­cur­rent or metasta­t­ic cer­vi­cal can­cer, ac­cord­ing to full da­ta from the Phase III KEYNOTE-826 study pre­sent­ed Sat­ur­day at #ES­MO21.

The Keytru­da arm post­ed a me­di­an OS of 24.4 months com­pared with 16.5 months for the chemo arm, Mer­ck said. Mean­while, the Keytru­da arm al­so post­ed a me­di­an pro­gres­sion-free sur­vival of 10.4 months com­pared with 8.2 months in the chemo arm (p=<0.001). Pa­tients in the Keytru­da arm post­ed a re­sponse rate of 65.9% com­pared with 50.8% in the chemo arm, and a me­di­an du­ra­tion of re­sponse of 18 months com­pared with 10.4 months.

Mer­ck toplined these re­sults back in June, which the drug­mak­er called a first-time clin­i­cal out­comes win for im­munother­a­py in first-line cer­vi­cal can­cer re­gard­less of pa­tients’ PD-L1 sta­tus. The 826 study served a dou­ble pur­pose as the con­fir­ma­to­ry tri­al for Keytru­da’s ap­proval in sec­ond-line cer­vi­cal can­cer, which the FDA grant­ed an ac­cel­er­at­ed ap­proval back in June 2018.

The KEYNOTE-158 study on which that ap­proval was based showed an ORR of 14.3% at an 11.7-month fol­low-up with 2.6% of pa­tients post­ing com­plete re­spons­es and 11.7% post­ing par­tial re­spons­es.

There are near­ly 14,500 new cas­es of in­va­sive cer­vi­cal can­cer di­ag­nosed each year in the US with near­ly 4,300 deaths in the US in 2021, Mer­ck said. Five-year sur­vival rate for ad­vanced cer­vi­cal can­cer is es­ti­mat­ed at about 17% with most pa­tients di­ag­nosed be­tween the ages of 35 and 44.

Like Keytru­da’s oth­er re­cent wins in ear­ly lines of ther­a­py, the KN-826 win rep­re­sents the megablock­buster’s ar­rival in an­oth­er first-line in­di­ca­tion, po­ten­tial­ly of­fer­ing ear­ly in­ter­ven­tion in a dis­ease that is the sec­ond-largest can­cer killer in women world­wide.

The re­sults are al­so a qui­et slap­down for Avastin, the wide­ly used stan­dard of care across mul­ti­ple women’s can­cer in­di­ca­tions since the sur­vival re­sults were most­ly con­sis­tent re­gard­less of whether the old­er drug was in­clud­ed in treat­ment.

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.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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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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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.