Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In re­cent months, the bat­tle for PD-(L)1 dom­i­nance has spilled over in­to ear­ly can­cer with Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo all alone on the front lines. Keytru­da now has an­oth­er shell in its ban­dolier, and it could spell a quick ap­proval.

Keytru­da cut the risk of re­lapse or death by 35% over place­bo (p=0.00658) in high-risk, stage 2 melanoma pa­tients who had pre­vi­ous­ly un­der­gone surgery to re­move their tu­mors, ac­cord­ing to full da­ta from the Phase III KEYNOTE-716 pre­sent­ed Sat­ur­day at #ES­MO21.

It’s Keytru­da’s lat­est win in what is known as ad­ju­vant/neoad­ju­vant can­cer, mak­ing good on Mer­ck’s mis­sion to bring its block­buster PD-1 in­hibitor in­to pa­tients be­fore their can­cer ever ad­vances. The FDA ac­cept­ed these da­ta for pri­or­i­ty re­view in Au­gust.

At a 14.4-month in­ter­im check-in, 11.1% of 487 pa­tients dosed with Keytru­da had re­lapsed or died com­pared with 16.8% of pa­tients on place­bo in the ran­dom­ized test. The Keytru­da arm saw few­er “dis­tant re­cur­rences” at 4.7% of pa­tients com­pared with 7.8% in the place­bo arm.

Mer­ck Re­search Labs CMO and Keytru­da czar Roy Baynes had this to say about the re­sults:

We con­duct­ed KEYNOTE-716 to ex­plore whether ad­ju­vant Keytru­da, an ap­proved ad­ju­vant treat­ment op­tion across all re­sect­ed stage III melanoma, could pro­long re­cur­rence-free sur­vival for pa­tients with re­sect­ed high-risk stage II dis­ease. These find­ings of a sig­nif­i­cant 35% re­duc­tion in the risk of dis­ease re­cur­rence or death com­pared to place­bo sup­port ear­li­er in­ter­ven­tion with Keytru­da. We are pleased that these find­ings have been ac­cept­ed for pri­or­i­ty re­view by the FDA, and we are grate­ful to the in­ves­ti­ga­tors and pa­tients for their in­volve­ment in this im­por­tant study.

Ear­ly can­cer has emerged as a key bat­tle­field for the biggest I/O play­ers, with drugs such as Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo set­tling in as stan­dards of care across ad­vanced can­cer and squab­bling over rel­a­tive­ly mi­nor in­di­ca­tions. But ad­ju­vant/neoad­ju­vant can­cer — and the po­ten­tial to prove im­mune check­point in­hibitors can be cu­ra­tive op­tions — has dri­ven those two biggest play­ers in­to a heat­ed con­test for pa­tients, with big rev­enues on the line.

Mer­ck toplined da­ta from the 716 study back in Au­gust, just days af­ter the megablock­buster earned the FDA’s ap­proval to head in­to ear­ly breast can­cer pa­tients. The agency gave its rub­ber stamp to a reg­i­men of Keytru­da plus chemo as a neoad­ju­vant com­bo fol­lowed by ad­ju­vant Keytru­da monother­a­py in pa­tients with high-risk triple-neg­a­tive breast can­cer.

The da­ta un­der­scor­ing that ap­proval were par­tic­u­lar­ly con­tentious: FDA hand­ed Mer­ck a com­plete re­sponse let­ter on the re­sults, cit­ing a lack of ma­ture safe­ty da­ta and ques­tions over the piv­otal study’s patho­log­ic com­plete re­sponse end­point. But Mer­ck with­in weeks rolled out OS da­ta show­ing a win on more ma­ture sur­vival da­ta, and caus­ing the FDA to re­verse its ear­li­er de­ci­sion.

In ear­ly June, Mer­ck rolled out da­ta from the KEYNOTE-564 study for Keytru­da in ad­ju­vant kid­ney can­cer, with the drug cut­ting the risk of can­cer re­lapse or death by 32% af­ter a lit­tle more than two years com­pared with place­bo in re­nal cell car­ci­no­ma pa­tients with a mid-to-high risk of re­cur­rence af­ter a kid­ney re­moval, or af­ter re­moval of a kid­ney and metasta­t­ic le­sions.

Mean­while, Op­di­vo sports an ad­ju­vant ap­proval of its own from May in re­sect­ed esophageal or gas­troe­sophageal junc­tion (GEJ) can­cer with resid­ual patho­log­ic dis­ease in pa­tients who have re­ceived neoad­ju­vant chemora­dio­ther­a­py. The ap­proval was based on re­sults from the Phase III CHECK­MATE-577 study, which found a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in dis­ease-free sur­vival (DFS) over place­bo, which was de­fined as the time be­tween ran­dom­iza­tion and the first re­cur­rence date, or death, from any cause.

A month be­fore, the FDA grant­ed pri­or­i­ty re­view to Op­di­vo as an ad­ju­vant treat­ment in mus­cle-in­va­sive urothe­lial can­cer.

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.

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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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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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.