Tecen­triq pass­es neoad­ju­vant breast can­cer tri­al as Roche looks for ear­ly start on the next big check­point op­por­tu­ni­ty

Shot through hun­dreds of tri­als over the last decade, check­point in­hibitors have proven a ver­sa­tile tool. First ap­proved for melanoma, col­lec­tive­ly they now cov­er dozens of can­cer types and set­tings, earn­ing their de­vel­op­ers bil­lions in the process.

Large­ly, though, they have avoid­ed use in one of the most com­mon set­tings: Lo­cal­ized tu­mors typ­i­cal­ly treat­ed with ad­ju­vant or neo-ad­ju­vant ther­a­py. For drug com­pa­nies, Cowen es­ti­mat­ed last Oc­to­ber, it’s a po­ten­tial $110 bil­lion mar­ket, one they’re rapid­ly try­ing to fill. The firm not­ed a long list of tri­als were un­der­way and due to start read­ing out — for breast can­cer at least —  this Sep­tem­ber with a Roche study in neoad­ju­vant-stage triple-neg­a­tive breast can­cer.

That tri­al has now read out ahead of ex­pec­ta­tions. And the re­sults, Roche’s biotech sub­sidiary Genen­tech said, are pos­i­tive.

Known as IM­pas­sion031, the Phase III study en­rolled ear­ly-stage triple-neg­a­tive breast can­cer pa­tients who were sched­uled for surgery and gave them ei­ther Roche’s PD-L1 ther­a­py Tecen­triq plus the chemother­a­py Abrax­ane or sim­ply chemother­a­py alone. The ques­tion was whether pa­tients tak­ing Tecen­triq were more like­ly to have a patho­log­i­cal com­plete re­sponse — i.e. were more like­ly to show no signs of tu­mor tis­sue when they went in for surgery.

The an­swer was yes, Roche said, though da­ta have yet to be re­leased. The study be­gan in 2017 and aimed to en­roll 324 pa­tients, ac­cord­ing to clin­i­cal­tri­als.gov. The ben­e­fit was seen re­gard­less of whether a pa­tient was PD-L1 pos­i­tive, Roche said.

Last year, Tecen­triq be­came the first im­munother­a­py ap­proved for triple-neg­a­tive breast can­cer — a com­mon tu­mor type that has long elud­ed ad­vanced ther­a­pies be­cause pa­tients’ tu­mors don’t ex­press high quan­ti­ties of the re­cep­tors tar­get­ed drugs go af­ter. That ap­proval, though, was on­ly for metasta­t­ic pa­tients who are PD-L1 pos­i­tive.

Among check­point in­hibitors, Roche has tra­di­tion­al­ly lagged be­hind Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo, but the Swiss phar­ma could find a sig­nif­i­cant niche treat­ing these ear­ly tu­mors.

The next such breast can­cer tri­al Cowen ex­pects to reach pri­ma­ry com­ple­tion is IM­pas­sion050, for neoad­ju­vant and ad­ju­vant HER2-pos­i­tive breast can­cer. The com­pa­ny is al­so run­ning a col­orec­tal ad­ju­vant tri­al due to read out soon. A re­nal ad­ju­vant tri­al may not fin­ish un­til 2022 but is pro­ject­ed to be the first check­point study to read out in that set­ting.

They’ll be far from alone, though. Along with Roche, As­traZeneca, Bris­tol My­ers, and Eli Lil­ly may all put out da­ta lat­er this year in ad­ju­vant or neoad­ju­vant lung can­cer. Mer­ck, tra­di­tion­al­ly the leader in the check­point field with Keytru­da, has sev­er­al tri­als set to read out in the longer term, be­tween 2022 and 2027.

Suc­cess, too, is far from a guar­an­tee. The first ad­ju­vant tri­al Cowen ex­pect­ed to read out was IMvig­or010, test­ing Tecen­triq in a form of non-metasta­t­ic blad­der can­cer. They were right. A read­out came in late Jan­u­ary. The re­sults, how­ev­er, were neg­a­tive.

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.”