As tislelizum­ab gains trac­tion in Chi­na, BeiGene pulls the cur­tain on NSCLC da­ta sup­port­ing the PD-1 drug

In a world now brim­ming with check­point in­hibitors, com­pa­nies of­ten strug­gle to make a mark giv­en a raft of ther­a­pies have al­ready cap­tured a con­sid­er­able por­tion of the vast on­col­o­gy mar­ket.

BeiGene’s tislelizum­ab was the fourth PD(L)-1 in­hibitor to se­cure ap­proval in Chi­na — and as it works on ex­pand­ing its share the com­pa­ny has put out de­tailed da­ta on the use of the drug in cer­tain pa­tients with lung can­cer.

On­ly last month did BeiGene un­veil that tislelizum­ab in com­bi­na­tion with stan­dard chemother­a­py fared bet­ter than chemo alone as the first line of de­fense in pa­tients with ad­vanced squa­mous non-small cell lung can­cer (NSCLC). On Fri­day, as part of the key can­cer con­fer­ence Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy (AS­CO), the Chi­na-based drug­mak­er dis­closed the num­bers.

The 360-pa­tient tri­al, which test­ed the check­point in­hibitor with two dif­fer­ent chemo reg­i­mens against chemo alone, showed that the me­di­an time dur­ing which pa­tients did not see dis­ease pro­gres­sion in the tislelizum­ab com­bo groups was 7.6 months ver­sus 5.5 months for chemo alone.

Ob­jec­tive re­sponse rates were al­so “mean­ing­ful­ly high­er” — be­tween 73% and 75% in the tislelizum­ab groups, ver­sus 50% in the chemo alone arm. In ad­di­tion, treat­ment with the BeiGene drug al­so rough­ly dou­bled the me­di­an du­ra­tion of re­sponse com­pared to chemother­a­py alone: 8.2 months and 8.6 months for the two tislelizum­ab groups, ver­sus 4.2 months for the chemo arm.

Tislelizum­ab was first ap­proved in Chi­na in late 2019 for clas­si­cal Hodgkin’s lym­phoma and then lat­er for metasta­t­ic urothe­lial car­ci­no­ma pa­tients. The drug marked a key mile­stone in the coun­try — the first in­stance of a for­eign part­ner pro­duc­ing a mar­ket­ed drug un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem. BeiGene’s part­ner in this case is Ger­many’s Boehringer In­gel­heim, which is sup­ply­ing the PD-1 an­ti­body for com­mer­cial use us­ing a Shang­hai fa­cil­i­ty.

The ap­proval of tislelizum­ab in late 2019 was rough­ly a year af­ter the first ap­proval by Jun­shi for Tuoyi. In­novent’s Tyvyt and Mer­ck’s flag­ship Keytru­da were ush­ered in af­ter.

Tislelizum­ab, de­spite the crowd­ed land­scape, has had an en­cour­ag­ing launch. In the first quar­ter of 2020, the drug gen­er­at­ed about $52 mil­lion in sales, best­ing con­sen­sus ex­pec­ta­tions of $47 mil­lion, SVB Leerink’s An­drew Berens wrote in a note ear­li­er this month. He lift­ed his mar­ket share ex­pec­ta­tions for tislelizum­ab in Chi­na, vault­ing his in peak sales ex­pec­ta­tions to $768 mil­lion, up from $461 mil­lion pre­vi­ous­ly.

Da­ta from the non-squa­mous NSCLC pa­tient piv­otal study have al­ready been dis­closed, and the Chi­nese reg­u­la­tor is cur­rent­ly re­view­ing an ap­pli­ca­tion to mar­ket the drug in NSCLC pa­tients. Mean­while, in 2020 or ear­ly 2021, the com­pa­ny ex­pects to re­veal topline re­sults from a glob­al late-stage tri­al com­par­ing tislelizum­ab ver­sus do­c­etax­el in sec­ond and third-line NSCLC pa­tients as well as da­ta from the Phase 3 tri­al com­par­ing tislelizum­ab ver­sus chemother­a­py in sec­ond-line ad­vanced esophageal squa­mous-cell car­ci­no­ma pa­tients.

Mean­while, akin to pret­ty much every oth­er check­point in­hibitor mak­er, BeiGene is ex­plor­ing the use of its of­fer­ing in com­bi­na­tion with oth­er treat­ments. On­ly days ago, it said it would be test­ing two of part­ner Chi-Med’s drug can­di­dates, su­r­u­fa­tinib and fruquin­tinib, in com­bi­na­tion with tislelizum­ab, for the treat­ment of var­i­ous sol­id tu­mor can­cers, in the US, Eu­rope, Chi­na and Aus­tralia.

So­cial: Ma Luyao via Wiki­me­dia

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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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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.

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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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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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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