BeiGene beefs up PD-1 da­ta with pos­i­tive PhI­II re­sults for tislelizum­ab, this time in metasta­t­ic NSCLC

BeiGene has been an­gling to dis­rupt the PD-1 mar­ket for quite some time, and on Tues­day ap­peared to take one step clos­er.

The Chi­nese biotech an­nounced that a Phase III study eval­u­at­ing its PD-(L)1 check­point in­hibitor tislelizum­ab in metasta­t­ic non-small cell lung can­cer met its pri­ma­ry end­point of over­all sur­vival. BeiGene didn’t pro­vide num­bers or p-val­ues with Tues­day’s re­sults, but not­ed that this was the drug’s third Phase III in NSCLC to go pos­i­tive at the in­ter­im read­out.

Yong Ben

“As we con­tin­ue to ad­vance tislelizum­ab in its broad clin­i­cal pro­gram,” CMO Yong Ben said in a state­ment, “we ex­pect to see a grow­ing body of clin­i­cal ev­i­dence that we be­lieve will help fur­ther eval­u­ate this po­ten­tial­ly dif­fer­en­ti­at­ed check­point in­hibitor and sup­port po­ten­tial reg­u­la­to­ry fil­ings in Chi­na and glob­al­ly.”

This tri­al en­rolled 805 pa­tients and com­pared tislelizum­ab to do­c­etax­el in the sec­ond- or third-line set­ting for those who had pro­gressed on plat­inum-based chemother­a­py. Pa­tients were ran­dom­ized 2 to 1 to the drug arm.

BeiGene said that the pri­ma­ry was over­all sur­vival in both the in­ten­tion-to-treat pop­u­la­tion — those with lo­cal­ly ad­vanced or metasta­t­ic NSCLC — and pa­tients with high PD-L1 ex­pres­sion. Though the biotech was al­so look­ing at key sec­on­daries such as ob­jec­tive re­sponse rate, du­ra­tion of re­sponse and pro­gres­sion-free sur­vival, they did not di­vulge any de­tails on these da­ta.

In terms of safe­ty, re­sults proved con­sis­tent with the “known risks” of the drug, and no new safe­ty sig­nals were de­tect­ed.

Tislelizum­ab was the fourth PD-(L)1 in­hibitor to be ap­proved by Chi­nese reg­u­la­tors in the span of about 12 months when it re­ceived the green light just be­fore 2019 end­ed. The drug is al­so the first to use a for­eign part­ner in Boehringer In­gel­heim to be mar­ket­ed un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem.

The ini­tial in­di­ca­tion was third-line re­lapsed/re­frac­to­ry Hodgkin’s lym­phoma and it’s since been OK’d in blad­der can­cers with high PD-(L)1 ex­pres­sion. In ad­di­tion to metasta­t­ic NSCLC, BeiGene is eval­u­at­ing the drug in com­bi­na­tion with chemo for both ad­vanced squa­mous and non-squa­mous NSCLC.

Un­like in the metasta­t­ic are­na, which is for sec­ond- or third-line pa­tients, BeiGene is seek­ing ap­proval in the first-line set­ting for squa­mous and non-squa­mous NSCLC pa­tients.

Da­ta from those in­di­ca­tions have proved promis­ing, as the drug hit sim­i­lar PFS re­sults in both ar­eas ear­li­er this year when com­pared to chemo alone. At the time, SVB Leerink an­a­lyst An­drew Berens took a look at the big pic­ture, pre­dict­ing that, with ap­provals al­ready in two ar­eas and pos­i­tive out­comes in NSCLC, tislelizum­ab could end up with the broad­est la­bel among all Chi­nese do­mes­tic PD-(L)1 agents.

Giv­en that the drug has yet to be ap­proved out­side Chi­na, that could give BeiGene an ad­van­tage against its non-Chi­nese com­peti­tors, Berens said.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.