As­traZeneca ax­es an­oth­er R&D track on dur­val­um­ab af­ter once again falling be­hind ri­vals

As­traZeneca CEO Pas­cal So­ri­ot

It’s not easy be­ing fourth.

The R&D team at As­traZeneca had thought that its sin­gle-arm study for its Phase II tri­al of the PD-L1 check­point dur­val­um­ab might have of­fered a short­cut to an ap­proval for sec­ond-line head and neck can­cer. But Mer­ck eas­i­ly beat them to the mar­ket with Keytru­da for head and neck with a nod in Au­gust and now Bris­tol-My­ers is breath­ing down its neck in the hope that they can cat­a­pult ahead — which would be wel­come af­ter the em­bar­rass­ing lung can­cer de­ba­cle.

So now As­traZeneca says it is scrap­ping plans to file for an ear­ly ap­proval in the in­di­ca­tion, un­like­ly to find reg­u­la­tors in­ter­est­ed in speed­ing an OK. Da­ta are ex­pect­ed this quar­ter, but don’t look for any quick pub­lic dis­cus­sion of what in­ves­ti­ga­tors found. The da­ta will be for in­ter­nal dis­cus­sion on­ly, and in “due course,” ac­cord­ing to As­traZeneca’s Q3 wrap-up.

That leaves As­traZeneca play­ing catch-up with three com­bi­na­tion stud­ies in head and neck can­cer, adding the CT­LA-4 treat­ment treme­li­mum­ab with dur­val­um­ab. But the R&D team has run in­to a de­lay here as well af­ter the FDA opt­ed to drop a par­tial hold on the com­bos a cou­ple of weeks ago.

The par­tial hold was in­sti­tut­ed af­ter in­ves­ti­ga­tors tracked bleed­ing events in the Phase III pro­gram. But the com­pa­ny cau­tions that all oth­er stud­ies in oth­er can­cers are pro­ceed­ing as planned, not­ing that such bleed­ing events are not un­usu­al in head and neck can­cer.

That said, As­traZeneca can ill af­ford any de­lays in the de­vel­op­ment of dur­val­um­ab/treme­li­mum­ab now. The com­pa­ny al­ready de­layed its de­vel­op­ment time­line for the check­point in­hibitor to al­low for com­bi­na­tion stud­ies, which As­traZeneca is count­ing on to make a splash with a late ar­rival in the field.

Now its chief hope in the field lies in get­ting its com­bo ap­proach to reg­u­la­tors for first-line non-small cell lung can­cer, ahead of a com­bi­na­tion of Op­di­vo and Yer­voy from Bris­tol-My­ers. The first piv­otal late-stage da­ta are ex­pect­ed in H1 2017.

It’s been a rough year for As­traZeneca, which has suf­fered a string of set­backs in 2016. And it’s not get­ting any eas­i­er. Mer­ck, Bris­tol-My­ers and Roche all beat the com­pa­ny to the mar­ket with im­pres­sive check­points, and the Pfiz­er/Mer­ck KGaA team is al­so play­ing catch-up as well.

As­traZeneca al­so out­lined the lat­est round of pro­grams to get cut out of the pipeline to­day. The scrap heap list in­clud­ed inebi­lizum­ab, its an­ti-CD19 an­ti­body, for dif­fuse large B cell lym­phoma, ME­DI3617 — a se­lec­tive an­giopoi­etin-2 in­hibitor — for sol­id tu­mors and cedi­ranib for PSR ovar­i­an can­cer. Back in Sep­tem­ber As­traZeneca pulled its ap­pli­ca­tion at the EMA for cedi­ranib, say­ing that reg­u­la­tors had some dif­fer­ing opin­ions on the drug’s safe­ty/ben­e­fit ra­tio.

As­traZeneca CEO Pas­cal So­ri­ot prefers to sweep away set­backs in foot­notes, re­serv­ing the head­line treat­ment for new pipeline ad­vances. To­day, though, the im­pact of gener­ic com­pe­ti­tion con­tin­ued to sav­age the phar­ma gi­ant’s rev­enue num­bers, set­ting a bleak back­ground for So­ri­ot’s trade­mark R&D bull­ish­ness. The com­pa­ny has scored sig­nif­i­cant progress with two new can­cer drugs, Tagris­so and Lyn­parza, but the com­pa­ny is not mak­ing near­ly the progress it promised in­vestors when So­ri­ot fend­ed off a takeover at­tempt by Pfiz­er. As­traZeneca al­so post­ed $674 mil­lion in rev­enue from ex­ter­nal­iza­tion deals done on as­sets that have ei­ther failed to mea­sure up in the clin­ic or no longer fit the com­pa­ny’s com­mer­cial/R&D fo­cus, which leans heav­i­ly on dur­val­um­ab.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.