Leapfrog­ging ri­vals, Roche's Tecen­triq plus chemo nabs PFS end­point in front­line lung can­cer seg­ment

Roche has nabbed the first shot at a front­line in­di­ca­tion for a sig­nif­i­cant share of the all-im­por­tant lung can­cer mar­ket with to­day’s news that their check­point Tecen­triq hit the pri­ma­ry end­point on pro­gres­sion-free sur­vival for squa­mous non-small cell lung can­cer. Some an­a­lysts say that in­di­ca­tion could be worth more than a bil­lion dol­lars a year in added rev­enue.

San­dra Horn­ing

Re­searchers com­bined Tecen­triq with Abrax­ane-based chemo and com­pared it to chemo in first line pa­tients with ad­vanced NSCLC. At an in­ter­im point the com­bi­na­tion beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit. In­ves­ti­ga­tors will now keep on track­ing re­sults to see how OS mea­sures out.

There were no da­ta points in Roche’s state­ment. The pos­i­tive PFS re­sults, though, give Roche a chance to march ahead of a bevy of com­pe­ti­tion from Mer­ck, Bris­tol-My­ers Squibb and oth­ers in a key can­cer mar­ket where the com­pe­ti­tion has been in­tense. And they’ll like­ly get a help­ing hand from the FDA, which has been ea­ger to stamp these check­points from the ma­jor play­ers with ac­cel­er­at­ed ap­provals.

Jef­feries rushed out a note ear­ly Tues­day high­light­ing some block­buster po­ten­tial for Roche, which has been scram­bling to catch up with the lead­ers in check­point in­hi­bi­tion and looked to gain a first-to-mar­ket ad­van­tage here. They note:

IM­pow­er131 is an im­por­tant study for Roche. Squa­mous cell NSCLC, which ac­counts for c.25%-30% of NSCLC, is a more com­pli­cat­ed dis­ease than non-squa­mous NSCLC and there are few­er treat­ment op­tions. Roche has pre­vi­ous­ly not­ed that it could be first to mar­ket in the 1L squa­mous NSCLC set­ting if IM­pow­er131 pro­duced a su­pe­ri­or re­sult. We cur­rent­ly mod­el $1.1bn of peak sales for Tecen­triq in this 1L squa­mous set­ting and have pre­vi­ous­ly high­light­ed that a pos­i­tive re­sult from the tri­al could see 1%-3% up­side to EPS and val­u­a­tion.

Mer­ck and Bris­tol-My­ers have tak­en the lead role in the over­all lung can­cer mar­ket, but none of the com­pe­ti­tion is ced­ing con­trol. IM­pow­er131 is one of five Phase III read­outs that Roche has for lung can­cer this year. And three more are in the clin­ic. Dur­ing their Q4 re­view last month, Roche phar­ma chief Daniel O’Day sound­ed bull­ish on Roche’s chances of carv­ing out a big piece of the mar­ket for it­self.

Their on­go­ing stud­ies, he said, “will di­men­sion­al­ize the first-line lung can­cer space in 2018.”

“I’m con­vinced there will be mul­ti­ple op­tions for dif­fer­ent pa­tient types in this set­ting which ac­counts for around 45% of the lung can­cer set­ting. I’m al­so con­vinced that we’ll play a very im­por­tant role there.”

That won’t come easy, though. Roche’s lat­est win in Phase III is its third in a mat­ter of months, but with 5 check­points on the mar­ket, every­one is promis­ing to play hard to beat the com­pe­ti­tion. And be­ing first may be an ad­van­tage, but it’s no guar­an­tee of mar­ket suc­cess. Mer­ck is al­so ex­pect­ed to pro­vide a read out in the same can­cer seg­ment soon from KEYNOTE-407.

“Squa­mous non-small cell lung can­cer is dif­fi­cult to treat and there have been lim­it­ed new treat­ment op­tions over the last few decades,” said San­dra Horn­ing, Roche’s chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment. “We will share the IM­pow­er131 re­sults with glob­al health au­thor­i­ties and we look for­ward to see­ing more ma­ture over­all sur­vival da­ta.”

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.

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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.”