As­traZeneca gets a green light on Imfinzi for small-cell lung can­cer — set­ting the stage for a bat­tle with Roche's Tecen­triq

The stan­dard-of-care for small-cell lung can­cer (SCLC) for decades was plat­inum-based chemother­a­py, but that par­a­digm shift­ed in 2018, with the ap­proval of Bris­tol My­ers Squibb’s check­point in­hibitor Op­di­vo in the sec­ond-line set­ting. Since then, a slate of im­munother­a­pies have se­cured SCLC ap­provals, and the lat­est is As­traZeneca’s flag­ship Imfinzi, which was ap­proved on Mon­day in com­bi­na­tion with stan­dard chemother­a­py as the first line of de­fense in ex­ten­sive-stage SCLC pa­tients.

The ap­proval was based on the re­sults of the late-stage, 805 pa­tient-CASPI­AN tri­al, which test­ed Imfinzi plus stan­dard-of-care chemother­a­py, or Imfinzi and chemother­a­py with the ad­di­tion of As­traZeneca’s in-house CT­LA-4 drug treme­li­mum­ab, ver­sus chemother­a­py alone.

The pri­ma­ry end­point was over­all sur­vival in each of the two ex­per­i­men­tal arms. The com­bi­na­tion of Imfinzi and chemother­a­py cut the risk of death by 27% (HR: 0.73; p=0.0047). Pa­tients on the Imfinzi arm lived a me­di­an 13 months longer, ver­sus 10.3 months in the chemother­a­py group.

The arm with treme­li­mum­ab failed to achieve the pri­ma­ry goal. The Imfinzi/treme­li­mum­ab com­bo, once tout­ed as the cor­ner­stone of As­traZeneca’s check­point de­vel­op­ment strat­e­gy, has al­ready seen a raft of fail­ures in the past — it did not im­prove over­all sur­vival in cer­tain pa­tients with head and neck can­cer, in ad­di­tion to the big flop in the keen­ly-watched MYS­TIC non-small cell lung can­cer (NSCLC) tri­al. Al­though the duo has, when com­bined with chemother­a­py, worked in de­lay­ing dis­ease pro­gres­sion in front­line cas­es of stage 4 NSCLC.

Roche’s Tecen­triq in com­bi­na­tion with chemother­a­py was ap­proved first-line treat­ment for ex­tend­ed stage SCLC last Sep­tem­ber, based on a 30% re­duc­tion in risk of death ob­served in the piv­otal IM­pow­er133 tri­al. Months ear­li­er in June, Mer­ck’s key­stone check­point in­hibitor Keytru­da had scored FDA ap­proval as a monother­a­py for the treat­ment of SCLC pa­tients who had pro­gressed on or af­ter plat­inum-based chemother­a­py and at least one pri­or line of ther­a­py.

On Mon­day, the FDA ap­proved the Imfinzi plus chemother­a­py com­bi­na­tion as a first-line treat­ment for ex­tend­ed-stage SCLC pa­tients, pit­ting against Tecen­triq it in the ex­act same pa­tient pop­u­la­tion.

Mean­while, Phar­ma­Mar’s lur­binecte­din re­ceived pri­or­i­ty re­view last month for the treat­ment of SCLC pa­tients who pro­gressed on plat­inum ther­a­py based on da­ta from a sin­gle-arm, mid-stage study show­ing an over­all re­sponse rate (ORR) of about 35%.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. About two-thirds of SCLC pa­tients are di­ag­nosed with ex­tend­ed stage-SCLC, in which the can­cer has spread wide­ly through the lung or to oth­er parts of the body.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pfiz­er's Xalko­ri fol­low-up, which smoked the old­er drug in 1st-line pa­tients, scores dou­ble win at the FDA

Despite being the first to market in ALK-positive non-small cell lung cancer, Pfizer’s Xalkori languished on the shelf as other competitors outpaced it. Now, after Pfizer’s follow-up drug absolutely smoked Xalkori in first-line patients, the FDA is taking notice.

In one fell swoop, the agency approved Lorbrena as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive NSCLC and extended the drug’s 2018 accelerated approval to a full approval, Pfizer announced on Wednesday.

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Lat­est Mass­Bio re­port shows just how much bio­phar­ma's biggest sec­tor boomed in 2020

It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.

The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Amid back of­fice con­sol­i­da­tion, Gilead ax­es 179 jobs in Cal­i­for­nia

Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.

Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.

Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.