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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.