NICE stays sour on As­traZeneca's Tagris­so

Months ago, British drug­mak­er As­traZeneca made its case for the use of Tagris­so as the first line of de­fense in cer­tain pa­tients with lung can­cer with an analy­sis that showed the drug helped pa­tients car­ry­ing the EGFR mu­ta­tion live longer ver­sus first-gen­er­a­tion ty­ro­sine ki­nase in­hibitors. But the UK’s cost-ef­fec­tive­ness watch­dog NICE is not con­vinced — on Wednes­day, the agency is­sued its fi­nal guid­ance re­fus­ing to en­dorse the drug.

EGFR-pos­i­tive non-small cell lung can­cer oc­curs in around 10% of lung can­cer cas­es. Cur­rent­ly, the first line of treat­ment, en­dorsed by NICE, for lo­cal­ly ad­vanced stages of the dis­ease is a dai­ly oral dose of Boehringer In­gel­heim’s afa­tinib (brand­ed Gilotrif), Roche and Astel­las’ er­lotinib (Tarce­va), As­traZeneca’s own gefi­tinib (Ires­sa) or Pfiz­er’s da­comi­tinib (Viz­im­pro). Afa­tinib is cur­rent­ly the most pre­scribed EGFR TKI in Eng­land for this pop­u­la­tion.

Da­ta from the FLAU­RA tri­al, pub­lished in 2017, showed that Tagris­so (known chem­i­cal­ly as os­imer­tinib) helped stall can­cer growth in the pa­tient pop­u­la­tion for around 18.9 months, ver­sus 10.2 months in pa­tients who re­ceived er­lotinib or gefi­tinib.

How­ev­er, there is no di­rect ev­i­dence com­par­ing the treat­ment with afa­tinib, which may be more ef­fec­tive than er­lotinib or gefi­tinib, NICE said.

Over­all sur­vival da­ta from FLAU­RA were very im­ma­ture (25% of events), NICE said, but the in­ter­im re­sults did show that os­imer­tinib ex­tend­ed over­all sur­vival com­pared with stan­dard care. “This pro­duced a haz­ard ra­tio of 0.63 (95% CI 0.45 to 0.88; p=0.007) which was not sta­tis­ti­cal­ly sig­nif­i­cant (a p val­ue of less than 0.0015 was need­ed for the re­sult to be sig­nif­i­cant).”

As­traZeneca ap­pealed NICE’s neg­a­tive draft guid­ance in Ju­ly 2019.

Months lat­er, the com­pa­ny un­veiled over­all sur­vival da­ta that showed that pa­tients on Tagris­so saw 38.6 months ver­sus 31.8 months on Tarce­va or Ires­sa, elic­it­ing a haz­ard ra­tio of 0.799 (p=0.0462).

Dave Fredrick­son As­traZeneca

The hope is that these new OS da­ta can bol­ster Tagris­so’s stand­ing as a first-line treat­ment, es­pe­cial­ly as As­traZeneca seeks re­im­burse­ment around the world, not­ed Dave Fredrick­son, who heads As­traZeneca’s glob­al on­col­o­gy busi­ness, at the Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy (ES­MO) meet­ing in Barcelona.

“Os­imer­tinib does not meet NICE’s end of life cri­te­ria. The cost-ef­fec­tive­ness es­ti­mates are high­er than NICE nor­mal­ly con­sid­ers an ac­cept­able use of NHS re­sources, so os­imer­tinib is not rec­om­mend­ed,” NICE said on Wednes­day.

As­traZeneca ex­pressed its dis­ap­point­ment in a state­ment.

“NHS pa­tients in Eng­land and Wales will not have ac­cess to a treat­ment that is be­com­ing the stan­dard of care in the 18 coun­tries in which it is now re­im­bursed, in­clud­ing Ger­many, Spain, Italy and Cana­da. As­traZeneca hopes to con­tin­ue dis­cus­sions with NHS Eng­land to en­able pa­tient ac­cess to this treat­ment,” the com­pa­ny said.

Tagris­so, which was As­traZeneca’s top-sell­ing treat­ment in the first nine months of 2019, car­ries a list price of £5,770 for 80 mg and 40 mg. The com­pa­ny has a com­mer­cial arrange­ment (i.e. a dis­count), which would have ap­plied if the drug had been rec­om­mend­ed.

Lars Fruergaard Jørgensen, chief executive officer of Novo Nordisk A/S, (via Getty Images)

The list of the 11 block­busters-to-be in line for a 2020 launch high­light agony and ec­sta­sy of drug R&D

For all the talk about unmet medical need and patients first and so on, the key criteria investors watch for any new drug in the pipelines is peak sales projection. Are you going to hit the blockbuster mark, at $1 billion-plus, or are you going to be an also-ran in the sales department?

Of course, analysts’ peak sales projections by themselves are of limited value in many cases. When the PCSK9 drugs started arriving 5 years ago, Repatha was billed as a $2.5 billion peak earner. They’re nowhere near that, with new competition threatening current levels. And if Biogen’s controversial Alzheimer’s drug aducanumab (submission planned but not on the list) is approved, per chance, will payers cover it?

Maybe not. And then those $10 billion in peak sales assumptions would go straight down the drain.

But, analysts are analysts, and peak sales projections have to be factored in when assessing the top experimental drugs up for a launch in the year ahead.

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Every 6 months, as longtime followers will know, I like to list the top 10 disasters in clinical R&D. And it seems like every new round-ups the ante a little more on just what qualifies for a top blooper of the year.

H2 2019 is certainly a standout, with a Big Pharma data scandal, a couple of blockbuster M&A busts and a whole run of Alzheimer’s setbacks to contemplate as we watch the Biogen saga play out. Not only does the Alzheimer’s field continue to crater, but we watched antibiotics come apart in the last 6 months of 2019.

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AstraZeneca executives at earnings conference, February 2020 (Natalie Grover for Endpoints News)

Coro­n­avirus out­break clouds As­traZeneca's Q4 re­sults and 2020 out­look

LONDON — With nearly a fifth of total sales coming from China, AstraZeneca counts the coronavirus-hit nation as one of its biggest growth drivers. The impact of the deadly epidemic has unsurprisingly weighed on the British drugmaker’s fourth-quarter results.

On Friday, AstraZeneca posted fourth-quarter sales of $6.25 billion, just shy of Wall Street estimates. Nearly $1.2 billion of that product revenue came from China.

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Carl June, via Getty

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In August of 2011, Carl June and his team published a landmark paper showing their CAR–T treatment had cleared a patient of cancer. A year-to-the-month later, Jennifer Doudna made an even bigger splash when she published the first major CRISPR paper, setting off a decade of intense research and sometimes even more intense public debate over the ethics of what the gene-editing tool could do.

Last week, June, whose CAR–T work was eventually developed by Novartis into Kymriah, published in Science the first US paper showing how the two could be brought together. It was not only one of the first time scientists have combined the groundbreaking tools, but the first peer-reviewed American paper showing how CRISPR could be used in patients.

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Joerg Moeller via Getty

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No matter how hard politicians in Washington DC pound on pharma companies for setting astronomical drug prices, they can’t seem to change one thing: The most expensive keep getting more expensive.

List prices for the most costly therapies, of course, is not fully representative of all prescription drugs for a variety of reasons, not the least because patients almost never end up paying that full amount — a fact the biopharma world likes to highlight. But the update on GoodRx’s running list of the 20 most expensive drugs in the US is still illustrative of the unabating trend of megapricing.

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Ruud Dobber, AstraZeneca

If you were a can­cer pa­tient, where would you rather be — the Unit­ed States or Eu­rope?

LONDON — Frustrated by the lack of legislation implemented to lower soaring drug prices in the United States — a key issue that has elicited outrage across both ends of the political spectrum — the White House recently issued a report suggesting that US drug prices aren’t unreasonable, it’s that developed nations aren’t paying their fair share.

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