Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfiz­er and Mer­ck KGaA have de­tailed the Phase III da­ta that in­spired FDA reg­u­la­tors to des­ig­nate Baven­cio a “break­through” for first-line ad­vanced blad­der can­cer and of­fered an ear­ly glance at how the PD-L1 can help pa­tients with a rare gy­ne­co­log­i­cal can­cer — carv­ing out nich­es in the check­point space for it­self af­ter be­ing shut out of nu­mer­ous oth­ers.

In JAVELIN Blad­der 100, Baven­cio led to a 31% re­duc­tion in risk of death com­pared to stan­dard care alone. It al­so ex­tend­ed me­di­an sur­vival by more than sev­en months — a his­toric feat in this set­ting, ac­cord­ing to in­ves­ti­ga­tors at Queen Mary Uni­ver­si­ty of Lon­don.

All 700 pa­tients in the tri­al com­plet­ed chemother­a­py be­fore get­ting ran­dom­ized to ei­ther main­te­nance ther­a­py with Baven­cio or reg­u­lar check­ing. Those on the drug arm saw mOS of 21.4 months, com­pared with 14.3 months on the com­para­tor group.

Around one in 10 pa­tients stopped the drug due to treat­ment prob­lems, though the com­pa­nies said side ef­fects were in line with ex­pec­ta­tions.

“This high­lights the po­ten­tial ben­e­fits of a main­te­nance ap­proach with avelum­ab in pa­tients to pro­long their lives fol­low­ing chemother­a­py,” Thomas Powles, a study lead and pro­fes­sor of gen­i­touri­nary on­col­o­gy at Queen Mary, said in a state­ment.

The find­ings could be “prac­tice-chang­ing,” he added, es­pe­cial­ly con­sid­er­ing these pa­tients have can­cer that has spread be­yond the blad­der.

The drug was al­ready sanc­tioned, un­der ac­cel­er­at­ed ap­proval, for use in pa­tients fol­low­ing dis­ease pro­gres­sion — an OK ce­ment­ed by tu­mor re­sponse and du­ra­tion of re­sponse back in 2017. Pfiz­er and Mer­ck KGaA have sub­mit­ted an ap­pli­ca­tion for a full OK.

With As­traZeneca’s PD-L1 Imfinzi fail­ing to prove it­self in a piv­otal study (de­spite hav­ing an ac­cel­er­at­ed ap­proval), they have few ri­vals to wor­ry about.

That’s like­ly the same mind­set that the two phar­ma gi­ants are tak­ing in­to ges­ta­tion­al tro­phoblas­tic tu­mors, a kind of ab­nor­mal growth of cells in­side a woman’s uterus. It’s a small Phase II study that en­rolled on­ly 15 pa­tients, but re­searchers were en­cour­aged by how Baven­cio kept the dis­ease from re­turn­ing in eight of them. One pa­tient even went on to have a healthy preg­nan­cy.

The pa­tients en­rolled in­to the Phase II are re­sis­tant to mono­chemother­a­py and must en­dure tox­ic chemo reg­i­mens. The main ef­fi­ca­cy mea­sure was the nor­mal­iza­tion of a hor­mone known as hu­man chori­on­ic go­nadotropin.

No oth­er im­munother­a­py has been test­ed in GTT pa­tients be­fore, sci­en­tists wrote in an ab­stract, but PD-L1 is ex­pressed in all sub­types of this can­cer.

A group of re­searchers in South Ko­rea have al­so planned a sim­i­lar study with Mer­ck’s Keytru­da, ac­cord­ing to clin­i­cal­tri­als.gov.

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.