Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling be­hind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecen­triq with a grow­ing ex­per­tise in lung can­cer. The drug will now take an ear­ly lead in the sought-af­ter ad­ju­vant set­ting — but com­peti­tors are on the way.

The FDA on Fri­day ap­proved Tecen­triq as an ad­ju­vant ther­a­py for pa­tients with Stage II-II­IA non small cell lung can­cer with PD-(L)1 scores greater than or equal to 1, mak­ing it the first drug of its kind ap­proved in an ear­ly set­ting that cov­ers around 40% of all NSCLC pa­tients.

The agency based its re­view on da­ta from the Phase III IM­pow­er010 study, which showed ad­ju­vant Tecen­triq cut the risk of re­lapse or death by 34% over best sup­port­ive care. Tecen­triq was placed on pri­or­i­ty re­view from the agency in this in­di­ca­tion back in ear­ly Au­gust, mak­ing it a speedy turn­around from the FDA.

Tecen­triq’s win here could spell block­buster sales, with some an­a­lysts pre­dict­ing a mar­ket op­por­tu­ni­ty of more than $1 bil­lion for the drug. The ap­proval could al­so be the first of many in ear­ly NSCLC, one of the largest can­cer in­di­ca­tions in the US, where Tecen­triq has carved out a niche de­spite stiff com­pe­ti­tion from some of the best sell­ing drugs in the world.

Ad­ju­vant/neoad­ju­vant im­munother­a­py care has emerged as a new fron­tier in the fight be­tween the PD-(L)1s with Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo tak­ing home wins of their own across oth­er tu­mor types. Both drug­mak­ers have hopes in NSCLC as well, with Mer­ck look­ing at Keytru­da as part of the Phase I MK3475-223 study for ad­ju­vant Stage I-II NSCLC.

Mean­while, Bris­tol My­ers is much fur­ther along in its Phase III CHECK­MATE-816, test­ing a com­bi­na­tion of Op­di­vo and chemother­a­py as a neoad­ju­vant — be­fore surgery — ther­a­py for Stage II-III NSCLC.

The drug read out topline da­ta from one of the study’s pri­ma­ry end­points in April show­ing the com­bo post­ed a 24% patho­log­i­cal com­plete re­sponse rate for pa­tients across the PD-(L)1 ex­pres­sion spec­trum com­pared with just 2.2% for chemo alone. The drug­mak­er is wait­ing out re­sults on event-free sur­vival, the study’s sec­ond ma­jor end­point, which could set up a fil­ing close af­ter.

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.

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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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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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.

Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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