AstraZeneca CEO Pascal Soriot [via AP]

As­traZeneca's flag­ship Tagris­so helps lung can­cer pa­tients live longer in piv­otal study

As­traZeneca is off to a good start in Au­gust. Af­ter its PARP in­hibitor Lyn­parza scored in a prostate can­cer tri­al ear­li­er this week, the British drug­mak­er on Fri­day dis­closed that its star can­cer drug Tagris­so helped pa­tients with a cer­tain type of lung can­cer live longer in a late-stage study.

The over­all sur­vival da­ta fol­lows pos­i­tive pro­gres­sion-free sur­vival da­ta un­veiled in 2017 from the FLAU­RA Phase III tri­al in­volv­ing pa­tients with metasta­t­ic epi­der­mal growth fac­tor re­cep­tor (EGFR) mu­ta­tion-pos­i­tive non-small cell lung can­cer (NSCLC). As­traZeneca es­ti­mates rough­ly 10-15% of pa­tients in the US and Eu­rope, and 30-40% of pa­tients in Asia have EGFR-mu­tat­ed NSCLC.

In the first half of 2019, Tagris­so was As­traZeneca’s $AZN biggest sell­er, rak­ing in $1.4 bil­lion in sales. The drug is cur­rent­ly ap­proved in 74 coun­tries, in­clud­ing the Unit­ed States, Japan and the EU for first line EGFR-pos­i­tive metasta­t­ic NSCLC.

The FLAU­RA tri­al as­sessed the ef­fi­ca­cy and safe­ty of Tagris­so oral­ly once dai­ly against com­para­tor treat­ments (ei­ther Tarce­va from Roche and Astel­las or Ires­sa from As­traZeneca’s own ar­se­nal) in 556 pa­tients across 29 coun­tries. Da­ta showed the drug near­ly dou­bled me­di­an pro­gres­sion-free sur­vival to 18.9 months ver­sus 10.2 months achieved by Tarce­va and Ires­sa.

On Fri­day, As­traZeneca said Tagris­so con­ferred a sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly-mean­ing­ful im­prove­ment in over­all sur­vival — al­though de­tails will be pro­vid­ed at a lat­er date.

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. Lung can­cer has a poor prog­no­sis; sta­tis­tics sug­gest over half of peo­ple di­ag­nosed die with­in one year of di­ag­no­sis and the av­er­age 5-year over­all sur­vival rate is less than 18%.

Con­sid­ered one of the most com­mer­cial­ly re­ward­ing con­di­tions to treat, As­traZeneca had pinned its hopes on the com­bi­na­tion of its check­point in­hibitor Imfinzi with its in-house CT­LA-4 drug in the keen­ly watched MYS­TIC tri­al ear­li­er this year, but that bet proved cost­ly. Imfinzi is now in de­vel­op­ment as a monother­a­py, as well as a chemother­a­py com­bi­na­tion, for lung can­cer pa­tients with­out a known ge­net­ic mu­ta­tion.

De­spite a string of high-pro­file miss­es, chief Pas­cal So­ri­ot has made strides in his mis­sion to fix As­traZeneca’s once-ail­ing port­fo­lio bruised by gener­ic med­i­cines eat­ing in­to sales. The com­pa­ny has since sharp­ened its fo­cus on the lu­cra­tive field of on­col­o­gy with drugs such as Lyn­parza, Tagris­so and Imfinzi. In 2016, So­ri­ot had tout­ed Tagris­so as a $3 bil­lion an­nu­al earn­er, a key fea­ture in his big promise to de­liv­er $45 bil­lion in an­nu­al rev­enue in 2023.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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