Levi Garraway, Genentech CMO and head of global product development

Genen­tech touts pos­i­tive Phase III da­ta for Tecen­triq/Avastin com­bo in liv­er can­cer

The Tecen­triq and Avastin com­bi­na­tion met its pri­ma­ry end­point — re­cur­rence-free sur­vival — for peo­ple with liv­er can­cer, specif­i­cal­ly ear­ly-stage he­pa­to­cel­lu­lar car­ci­no­ma, in a Phase III study, Genen­tech an­nounced Thurs­day.

The in­ter­im analy­sis of the Phase III IM­brave050 study showed “sta­tis­ti­cal­ly sig­nif­i­cant” im­prove­ment in their tar­get pa­tients: peo­ple who have a high risk of the dis­ease re­turn­ing af­ter they’ve had ab­la­tion or surgery to re­move the can­cer. This im­prove­ment was com­pared to pa­tients who on­ly had ac­tive sur­veil­lance.

How­ev­er, no da­ta from the 662-per­son study were pro­vid­ed by the Roche sub­sidiary. The com­pa­ny said the over­all sur­vival da­ta were “im­ma­ture,” and it will now dis­cuss the re­sults with the FDA and the Eu­ro­pean Med­i­cines Agency and present them at a fu­ture med­ical meet­ing.

The tri­al par­tic­i­pants re­ceived ei­ther 1,200 mg of Tecen­triq every three weeks plus 15 mg of Avastin every three weeks for a max­i­mum of 12 months, or had no in­ter­ven­tion with ac­tive sur­veil­lance. Sec­ondary end­points in­clude over­all sur­vival.

“IM­brave050 is the first Phase III study to show that a can­cer im­munother­a­py com­bi­na­tion re­duced the risk of dis­ease re­turn­ing in peo­ple with this type of HCC,” Levi Gar­raway, chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment at Genen­tech, said in a press re­lease.

Near­ly 42,000 Amer­i­cans were di­ag­nosed with liv­er can­cer in 2022, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety’s es­ti­mate.

Tecen­triq is a mon­o­clon­al an­ti­body that in­hibits PD-L1 and re­ac­ti­vates T cells. Avastin, a bi­o­log­ic an­ti­body, binds to a spe­cif­ic pro­tein in or­der to ham­per a tu­mor’s blood sup­ply and slow the growth of new blood cells by in­hibit­ing VEGF-A.

Tecen­triq is al­ready ap­proved alone or in com­bi­na­tion with oth­er drugs for non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma if the dis­ease can’t be re­moved through surgery, melanoma and soft tis­sue tu­mors.

In 2020, the FDA ap­proved Avastin and Tecen­triq for pa­tients with un­re­sectable or metasta­t­ic he­pa­to­cel­lu­lar car­ci­no­ma af­ter Roche and Genen­tech pub­lished Phase III find­ings that showed the com­bo im­proved pro­gres­sion-free sur­vival. It al­so helped pa­tients live longer than the stan­dard-of-care since 2007, Bay­er’s Nex­avar. The com­bo be­came the first im­mune check­point ther­a­py to make it to the first line for these tu­mors.

How­ev­er, in Oc­to­ber 2021, the FDA pulled Tecen­triq from its ac­cel­er­at­ed ap­proval pipeline in com­bi­na­tion with pa­cli­tax­el pro­tein-bound for pa­tients with lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer. The FDA orig­i­nal­ly ap­proved the drug com­bo in 2019 based on pro­gres­sion-free sur­vival in a 902-per­son tri­al.

Oth­er com­pa­nies have en­tered the late stages of the im­mune check­point in­hibitor space, in­clud­ing Mer­ck and Ei­sai with Keytru­da in com­bi­na­tion with Lenvi­ma; Jiang­su Hen­grui and El­e­var Ther­a­peu­tics with PD-1 in­hibitor cam­re­lizum­ab along­side rivo­ceranib; and BeiGene with tislelizum­ab.

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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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

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.

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.

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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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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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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