Roche scores its first PD-L1 win in Chi­na, go­ing straight for SCLC niche

Just weeks af­ter As­traZeneca’s Imfinzi be­came the first and on­ly ap­proved PD-L1 drug in Chi­na, reg­u­la­tors have ush­ered in Roche’s Tecen­triq to the check­point fren­zy.

Hong Zhou

The Swiss phar­ma gi­ant is go­ing straight for a niche that it knows well: ex­ten­sive-stage small cell lung can­cer. Per its es­ti­mates, two thirds of SCLC pa­tients have reached this phase by the time they are di­ag­nosed, lead­ing to a poor prog­no­sis and an av­er­age 5-year sur­vival rate of 2% de­spite the use of chemo.

As with the US OK, Chi­na’s Na­tion­al Med­ical Prod­ucts As­so­ci­a­tion based its ap­proval on the Phase III IM­pow­er133 study, which showed that Tecen­triq in com­bi­na­tion with chemother­a­py helped peo­ple live sig­nif­i­cant­ly longer com­pared to chemother­a­py alone (me­di­an over­all sur­vival 12.3 months vs 10.3 months; p=0.0069). The Tecen­triq com­bo al­so re­duced the risk of the dis­ease wors­en­ing, with pro­gres­sion-free sur­vival reach­ing 5.2 months com­pared to 4.3 months on chemo alone (p=0.017).

Thanks to re­forms in­sti­tut­ed in 2017, these da­ta col­lect­ed from glob­al stud­ies went on to sup­port Chi­na ap­proval.

“In March 2019, the US FDA ap­proved Tecen­triq for the small cell lung can­cer in­di­ca­tion,” Hong Zhou, Roche’s Chi­na gen­er­al man­ag­er, said in a state­ment post­ed on WeChat. “In less than a year’s time, Tecen­triq was ap­proved in Chi­na for small cell lung can­cer. It is an­oth­er tes­ta­ment to the res­o­lu­tion as well as re­sults of the Chi­nese gov­ern­ment speed­ing up the re­view of new drugs such that Chi­nese pa­tients can have ac­cess to the lat­est drugs as Eu­ro­peans and Amer­i­cans.”

With PD-1 lead­ers Mer­ck and Bris­tol-My­ers al­ready in the mar­ket, Roche in­di­cat­ed that it would con­tin­ue to pur­sue the niche find­ing strat­e­gy that has suit it well, fo­cus­ing on small­er pa­tient pop­u­la­tion oth­er im­munother­a­pies may not have reached.

The win for Tecen­triq in small cell lung can­cer, it added, means it has full cov­er­age of the lung can­cer land­scape in Chi­na. Tarce­va (an­ti-EGFR), Ale­cen­sa (an­ti-ALK) and Avastin (an­ti-VEGF) are all po­si­tioned for non-small cell lung can­cer.

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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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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