Lag­ging fur­ther be­hind, As­traZeneca adds fresh de­tails to its check­point come­back strat­e­gy

As­traZeneca has sketched out some fresh de­tails on its mis­sion crit­i­cal piv­otal study on its check­point drug ap­proach to non-small cell lung can­cer, map­ping an­oth­er like­ly de­lay as the phar­ma gi­ant looks for its first big open­ing in the megablock­buster can­cer mar­ket.

The MYS­TIC study has been en­rolling lung can­cer pa­tients re­gard­less of PD-L1 ex­pres­sion sta­tus. In its state­ment to­day the phar­ma gi­ant says it will eval­u­ate pro­gres­sion-free sur­vival as well as over­all sur­vival for dur­val­um­ab com­bined with treme­li­mum­ab — its all-im­por­tant I/O + I/O matchup that will look to out­per­form the ther­a­pies al­ready ap­proved for front­line and sec­ond line pa­tients — for all com­ers as well as PD-L1 ex­pressers. And it will al­so now ex­plore the da­ta for dur­val­um­ab as a monother­a­py.

Sea­mus Fer­nan­dez, Leerink

Da­ta are ex­pect­ed now mid-year for PFS and no lat­er than some­time in 2018 for OS, which Sea­mus Fer­nan­dez at Leerink counts as a three-month de­lay:

“In the wake of MRK’s (MP) sur­prise fil­ing an­nounce­ment for its Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py com­bi­na­tion, AZN’s de­ci­sion to fo­cus on MYS­TIC’s best chance of suc­cess with ei­ther mono- or com­bo ther­a­py is ra­tio­nal, in our view,” Fer­nan­dez not­ed. “In ad­di­tion, the com­pa­ny’s strate­gic up­date on im­muno-on­col­o­gy (IO) monother­a­py (PEARL study) and com­bo ther­a­py (ex­pand­ed NEP­TUNE re­cruit­ment) pro­vides an­oth­er sub­stan­tial shot on goal for the com­pa­ny’s glob­al IO ef­forts.”

The NEP­TUNE study will be used to seek an OK in Chi­na for first-line use based on ear­li­er PFS da­ta while the new­ly launched PEARL will go af­ter PD-L1 ex­pressers in Asian mar­kets, where the rate of NSCLC runs high.

Mer­ck stunned the mar­ket re­cent­ly when it sped through a fil­ing for a com­bi­na­tion of Keytru­da with chemother­a­py in front­line NSCLC, putting some fresh dis­tance be­tween its big check­point and Bris­tol-My­ers Squibb’s ri­val Op­di­vo. Roche was the third play­er on the mar­ket with Tecen­triq, which is al­so in­volved in mul­ti­ple stud­ies.

As­traZeneca, which stum­bled through a se­ries of mishaps last year, des­per­ate­ly needs to do some­thing right with dur­val­um­ab to at least par­tial­ly sat­is­fy some big promis­es CEO Pas­cal So­ri­ot has made to in­vestors. A late ar­rival to the check­point mar­ket, ei­ther along­side or right be­hind Pfiz­er, leaves As­traZeneca with shrink­ing op­por­tu­ni­ties for mak­ing a splash.

It’s still pos­si­ble, though, and an­a­lysts aren’t count­ing the com­pa­ny out.

“While Keytru­da is now ap­proved in 1L pa­tients with PD-L1 ex­pres­sion of 50% or high­er, there re­mains “white space” for dur­va in PD-L1+ pa­tients with low­er (but still pos­i­tive) ex­pres­sion,” re­ports Fer­nan­dez.

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.

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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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.

John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”