Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

In a “check the box” ex­er­cise, Roche said it has shown that adding Tecen­triq to a com­bo of Cotel­lic and Zelb­o­raf was ef­fec­tive in ex­tend­ing pro­gres­sion-free sur­vival in melanoma pa­tients com­pared to place­bo plus the two drugs.

Pa­tients with pre­vi­ous­ly un­treat­ed BRAF V600 mu­ta­tions were re­cruit­ed to the Phase III study, dubbed IM­spire150.

Levi Gar­raway

Cotel­lic (which was ini­tial­ly de­vel­oped by Roche part­ner Ex­elix­is) and Zelb­o­raf are al­ready ap­proved to treat BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. While the lat­ter blocks some BRAF ki­nas­es, the for­mer is be­lieved to help break treat­ment re­sis­tance by al­so in­hibit­ing MEK1/2.

Some­times, though, that’s still not enough, thus the at­tempts to add a third agent to in­crease the dura­bil­i­ty of treat­ment — ei­ther a tar­get­ed ther­a­py or, in this case, an im­munother­a­py.

Roche has tried to test a com­bo of Tecen­triq plus just Cotel­lic for treat­ment-naive cas­es, but that com­bi­na­tion failed to beat stan­dard-of-care Keytru­da in a sep­a­rate tri­al, IM­spire170, un­veiled ear­li­er this year.

The phar­ma gi­ant record­ed around $44 mil­lion in Cotel­lic sales in the first three quar­ters of 2019, while Tecen­triq fetched over $1.3 bil­lion.

Cotel­lic and Zelb­o­raf had two heavy­weight ri­vals in No­var­tis, which mar­kets Mekin­ist and Tafin­lar, as well as Pfiz­er af­ter it snapped up Ar­ray and its Mek­tovi/Braftovi pair­ing. All play­ers are look­ing to go be­yond melanoma now — Pfiz­er is es­pe­cial­ly keen about the prospects in col­orec­tal can­cer — though Roche has suf­fered some set­backs.

Stifel an­a­lyst Stephen Wil­ley has pre­vi­ous­ly de­scribed the triplet vs dou­blet com­par­i­son as more of a “check the box” than “ex­pand the mar­ket” move.

The next step will be to check the reg­u­la­to­ry box.

“By com­bin­ing a can­cer im­munother­a­py with tar­get­ed ther­a­pies, we hope to of­fer a new ap­proach that im­proves out­comes for peo­ple with ad­vanced, BRAF-mu­tant melanoma,” CMO Levi Gar­raway said in a state­ment.

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.

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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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.”

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.

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.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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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.