Mer­ck pre­views an ear­ly hit with Keytru­da com­bo for kid­ney can­cer, putting more pres­sure on ri­val Bris­tol-My­ers

Mer­ck ar­rived at ES­MO in style, fronting their ap­pear­ance in Mu­nich with pos­i­tive — and very ear­ly — com­bi­na­tion da­ta for their PD-1 check­point star Keytru­da in treat­ing front­line kid­ney can­cer.

Re­searchers com­bined Keytru­da with Pfiz­er’s In­ly­ta for KEYNOTE-426 and came away with an ear­ly win on both pro­gres­sion-free and over­all sur­vival, along with a key sec­ondary in beat­ing Su­tent in a head-to-head show­down.

The hard da­ta will come lat­er at an­oth­er con­fer­ence, but the FDA gets to see it first as Mer­ck hus­tles for yet an­oth­er sup­ple­men­tal ap­proval for its fran­chise play­er.

Mer­ck’s team called this a win at a very ear­ly point, catch­ing an­a­lysts like Ever­core ISI’s Umer Raf­fat by sur­prise. The fi­nal da­ta weren’t ex­pect­ed be­fore the 2019/20 time frame. But Mer­ck has been pulling out all stops in its suc­cess­ful quest to push ahead of Bris­tol-My­ers Squibb, who now faces fresh com­pe­ti­tion on this front as well for its com­bi­na­tion of Op­di­vo-Yer­voy.

Bris­tol-My­ers won an OK for first line kid­ney can­cer ear­li­er in the year. But then the CHMP in Eu­rope turned thumbs down, say­ing the com­pa­ny had not “demon­strat­ed the con­tri­bu­tion of com­po­nents suf­fi­cient­ly well.” Bris­tol-My­ers is ap­peal­ing while Mer­ck looks to cut ahead of the line yet again.

“This marks the first time that com­bi­na­tion treat­ment with an an­ti-PD-1 ther­a­py has achieved the dual pri­ma­ry end­points of over­all sur­vival and pro­gres­sion-free sur­vival as first-line ther­a­py in ad­vanced re­nal cell car­ci­no­ma,” said Mer­ck R&D chief Roger Perl­mut­ter, who’s been over­see­ing a grid of hun­dreds of stud­ies for their PD-1. “Few­er than 10 per­cent of those di­ag­nosed with ad­vanced re­nal cell car­ci­no­ma sur­vive for five years, and hence there is sig­nif­i­cant need for im­proved ther­a­pies for this dis­ease.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Cure­Vac touts old­er adult da­ta for GSK-part­nered Covid-19, flu can­di­dates

Germany’s CureVac reported data Monday on older patients to beef up plans to advance vaccines for Covid-19 and seasonal flu.

In short, the Covid-19 data reveal the vaccine candidate, known as CV0501 targeting Omicron’s BA.1 variant, boosted titers of neutralizing antibodies by 13.3-fold after four weeks at the lowest 12 µg dose level. The data in these cohorts are still small, with 10 patients enrolled per dose. Some patients also received 25 and 50 µg doses.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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