As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

As­traZeneca has made a stride to­ward re­al­iz­ing its am­bi­tions in Chi­na as reg­u­la­tors green­light Imfinzi as a treat­ment for non-small cell lung can­cer.

In par­tic­u­lar, the PD-L1 agent is fill­ing a void for im­munother­a­pies in Stage III un­re­sectable case, the com­pa­ny said, where the can­cer has not spread to the rest of the body. It is to be used, with cu­ra­tive in­tent, in pa­tients whose can­cer hasn’t pro­gressed fol­low­ing con­cur­rent plat­inum-based chemother­a­py and ra­di­a­tion ther­a­py.

Dave Fredrick­son

“This ap­proval il­lus­trates our long-stand­ing com­mit­ment to im­prov­ing health out­comes in Chi­na, where more than one-third of the world’s lung can­cer di­ag­noses and deaths oc­cur,” said Dave Fredrick­son, who heads As­traZeneca’s on­col­o­gy busi­ness unit, in a state­ment.

Imfinz’s ap­proval al­so marks the en­try of a PD-L1 in­hibitor to the coun­try, where PD-1 drugs have been pil­ing up. Bris­tol-My­ers Squibb scored the first-ever Chi­nese ap­proval for a check­point in­hibitor in June 2018, with Op­di­vo in­di­cat­ed for sec­ond-line treat­ment of NSCLC, and Mer­ck has been rack­ing up OKs for dif­fer­ent reg­i­mens in­volv­ing Keytru­da.

Then there are the do­mes­tic ri­vals, whose drugs are cur­rent­ly lim­it­ed to lym­phoma or melanoma but al­so have plans for a lu­cra­tive lung can­cer mar­ket. And they are ea­ger to com­pete on price.

Leon Wang

For As­traZeneca, this is just more rea­son to roll up its sleeves and get to ne­go­ti­at­ing with pay­ers. Its head of Chi­na, Leon Wang, has pre­vi­ous­ly told Bloomberg that he sees new treat­ments con­tribut­ing to 60% of all its Chi­na rev­enue with­in five years. To il­lus­trate that dri­ve, Wang of­fered the ex­am­ple of its first-gen EGFR-tar­get­ing lung can­cer Ires­sa, in which they won the drug sup­ply con­tract in by slash­ing the price more than 70%.

Quick ap­provals for third-gen EGFR TKI Tagris­so (which is now on the Na­tion­al Re­im­burse­ment Drug List), as well as the PARP in­hibitor Lyn­parza, helped — and now it’s time for Imfinzi to shine. No­tably, Roche’s PD-L1 Tecen­triq — which gained FDA ap­proval ear­li­er than Imfinzi — is not yet avail­able in Chi­na.

In the Phase III PA­CIF­IC tri­al, Imfinzi cut the risk of death by 32% and pro­longed pro­gres­sion-free sur­vival by 11.2 months ver­sus place­bo (me­di­an PFS 16.8 vs 5.6 months), when paired with chemo or ra­di­a­tion ther­a­py. At the three-year mark, 57% of pa­tients on the Imfinzi arm are still alive com­pared to 43.5% on place­bo, ac­cord­ing to a post hoc analy­sis pre­sent­ed at AS­CO.

Imfinzi sales have gone over the $1 bil­lion mark in the first three quar­ters of the year, grow­ing 182% com­pared to the same pe­ri­od last year.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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No­var­tis to pay near­ly $178M in law­suit over BRAF drug — and will be on the hook for roy­al­ty

After a four-year battle over a cancer drug patent, Novartis has been ordered by a California judge to pay a Daiichi Sankyo subsidiary $177.8 million.

Plexxikon filed a lawsuit against the pharma giant in 2017, alledging that Tafinlar, a rival to its melanoma drug Zelboraf that was brought to market in collaboration with Roche, has stepped on its intellectual property. The jury ruled in its favor, adding that the infringement is in fact willful.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen de­fends slow roll­out of new Alzheimer's drug, crit­i­cizes neg­a­tive me­dia at­ten­tion

As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.

Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.