Mer­ck­'s Keytru­da takes home ad­ju­vant win in melanoma, es­ca­lat­ing ear­ly-line fight with Bris­tol My­ers

With im­mune check­point in­hibitors quick­ly emerg­ing as stan­dard of care across a broad range of ad­vanced can­cers, the biggest drug­mak­ers in the race are mak­ing a hard push in­to ear­li­er lines of ther­a­py to gain an edge. The biggest dog in the fight, Mer­ck, now has da­ta that could spell a quick ap­proval and sales bump.

Keytru­da beat out place­bo in staving off the re­cur­rence of can­cer as an ad­ju­vant ther­a­py in pa­tients with high-risk stage II melanoma af­ter surgery to re­move their tu­mors, ac­cord­ing to topline da­ta from the KEYNOTE-716 study re­leased Thurs­day.

Al­though full da­ta weren’t avail­able, the ear­ly look paints the pic­ture of a big win for Mer­ck, which is bat­tling for ear­li­er lines of ther­a­py for Keytru­da in a heat­ed fight among the PD-(L)1 play­ers, most no­tably Bris­tol My­ers Squibb’s Op­di­vo.

With da­ta in hand, Mer­ck snared a snap pri­or­i­ty re­view from the FDA with an ac­tion date set for Dec. 4. The drug­mak­er ex­pects to present full da­ta at an up­com­ing med­ical meet­ing.

The two-part KEYNOTE-716 study first ran­dom­ized pa­tients on Keytru­da or place­bo for up to a year of dos­ing af­ter surgery. That was fol­lowed by a two-year open-la­bel pe­ri­od for pa­tients who ei­ther did not see their dis­ease re­cur af­ter one year of Keytru­da or did see it re­cur on place­bo.

The da­ta add an­oth­er jew­el to Mer­ck’s crown in ad­ju­vant/neoad­ju­vant im­munother­a­py with oth­er wins in breast, blad­der and kid­ney can­cer al­ready on the mantle­piece.

Just days ago, the FDA ap­proved a reg­i­men of Keytru­da plus chemo as a neoad­ju­vant com­bo fol­lowed by ad­ju­vant Keytru­da monother­a­py in pa­tients with high-risk triple-neg­a­tive breast can­cer, which of­fi­cial­ly be­came the drug’s first win in that ear­ly-line set­ting.

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 that 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 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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Middletown, Delaware’s main claim to fame was the site location for the film the Dead Poets Society, the city will soon play host to a massive manufacturing outfit.

WuXi AppTec’s contract research and manufacturing subsidiary WuXi STA, has broken ground on a 190-acre manufacturing campus in Middletown.

According to the company, this site will be WuXi’s second facility in the US, and it will create around 500 full-time jobs by 2026, but there are plans to kick off operations in 2025.