Takeda CEO Christophe Weber (Getty Images)

Take­da an­nounces pos­i­tive new ALK+ lung can­cer da­ta as list of crizo­tinib suc­ces­sors widens

Take­da un­veiled new Phase III front­line da­ta for their ALK in­hibitor at Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy Asia Con­gress, show­ing it could de­ter the spread of lung can­cer for two years or more. But the tri­al com­pared the drug, Alun­brig (briga­tinib), against an ear­ly in­hibitor that is no longer best-in-class and the Japan­ese phar­ma will like­ly face sig­nif­i­cant com­pe­ti­tion if reg­u­la­tors grant an ex­pand­ed la­bel. 

“It’s part of the next gen­er­a­tion of ALK in­hibitors,” San­jay Popat, a tho­racic on­col­o­gist at Roy­al Mars­den Hos­pi­tal and an in­ves­ti­ga­tor on the tri­al, Al­ta-1L, told End­points News. “The up­dat­ed da­ta re­al­ly con­firms that briga­tinib is way su­pe­ri­or to crizo­tinib.”

San­jay Popat

The tri­al com­pared briga­tinib against crizo­tinib in 275 ad­vanced non-small-cell-lung-can­cer pa­tients who test­ed pos­i­tive for the ALK gene, and it pro­duced re­sults that don’t take a bio­sta­tis­ti­cian to un­der­stand.

The re­view com­mit­tee found pa­tients on briga­tinib went a me­di­an 24 months with­out the can­cer spread­ing, hit­ting the pri­ma­ry end­point. For crizo­tinib pa­tients? 11 months. (Take­da in­ves­ti­ga­tors found a slight­ly high­er PFS for briga­tinib and a slight­ly low­er PFS for crizo­tinib). 

In pa­tients whose can­cer had spread to the brain — a no­to­ri­ous­ly-dif­fi­cult place to de­liv­er com­pounds, in­clud­ing crizo­tinib — be­fore the start of the tri­al, the drug im­proved pro­gres­sion-free sur­vival by 76% against the con­trol arm, as as­sessed by in­ves­ti­ga­tors. 

“It’s de­signed to cross the blood-brain bar­ri­er,” Popat said of the drug. Pa­tients with brain metas­tases rep­re­sent­ed about 30% of each arm.

The prob­lem for Take­da is that the ALK-land­scape has changed con­sid­er­ably since the Phase III tri­al be­gan and since they ac­quired the com­pound in the $5.2 bil­lion Ari­ad deal. Even since the FDA grant­ed ac­cel­er­at­ed ap­proval for the drug as a sec­ond-line treat­ment in 2017.

Crizo­tinib, the con­trol in the tri­al, was the first ALK in­hibitor ap­proved and came with much ac­claim. While the drug was in Phase I in the late 2000s, the sto­ries of once-ter­mi­nal pa­tients watch­ing their tu­mors shrink made for TV news fod­der. But Pfiz­er, No­var­tis and Roche have all since un­veiled new in­hibitors that can be more ef­fec­tive than the first drug.

Re­searchers cau­tion against com­par­ing clin­i­cal tri­als too di­rect­ly, but Roche’s Ale­cen­sa al­so showed dra­mat­i­cal­ly im­proved pro­gres­sion free-sur­vival against crizo­tinib in sim­i­lar pa­tient pop­u­la­tions, bol­stered by im­proved re­sults in the cen­tral ner­vous sys­tem metas­tases.

Still, the drugs are not iden­ti­cal and, as with many can­cer drugs, re­sis­tance has be­come a prob­lem, with pa­tients rid­ing one in­hibitor while it works and then go­ing to the next. That makes each new in­hibitor a po­ten­tial life­line.

“The one thing that’s clear is that each of the next-gen in­hibitors have demon­strat­ed true su­pe­ri­or­i­ty,” Popat said. “So choos­ing which one is a de­ci­sion be­tween pa­tients and their on­col­o­gists.”

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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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.”

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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.