Roche's Tecen­triq ex­cels in an­oth­er lung can­cer study

Months af­ter se­cur­ing FDA ap­proval for Tecen­triq as a first line of de­fense — in com­bi­na­tion with chemother­a­py — in ex­ten­sive-stage small-cell lung can­cer pa­tients, Roche on Thurs­day said the im­munother­a­py helped cer­tain treat­ment-naive pa­tients with ad­vanced non-small cell lung can­cer (NSCLC) live longer ver­sus chemother­a­py, in a piv­otal study.

The 572-pa­tient tri­al, called IM­pow­er110, test­ed Tecen­triq monother­a­py against chemother­a­py (cis­platin or car­bo­platin and peme­trexed or gem­c­itabine) in pa­tients with ad­vanced non-squa­mous and squa­mous non-small cell lung can­cer in pa­tients with­out ALK or EGFR mu­ta­tions.

San­dra Horn­ing at an End­points News event dur­ing #JPM19 in San Fran­cis­co, Jan­u­ary 2019 End­points News

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The study met the main goal in an in­ter­im analy­sis show­ing that Tecen­triq monother­a­py sur­passed the ef­fect of chemother­a­py alone. “Tecen­triq monother­a­py has shown a sig­nif­i­cant sur­vival ben­e­fit over chemother­a­py as an ini­tial treat­ment in peo­ple with squa­mous or non-squa­mous non-small cell lung can­cer with high PD-L1 ex­pres­sion,” Roche’s out­go­ing CMO San­dra Horn­ing, said in a state­ment.

The study will con­tin­ue to con­duct the fi­nal analy­sis for pa­tients with low­er lev­els of PD-L1 ex­pres­sion, the Swiss drug­mak­er added. Roche is set to sub­mit the dataset — de­tails of which will be dis­closed at a fu­ture med­ical con­fer­ence — to health reg­u­la­tors in the Unit­ed States and Eu­rope.

Roche has nine Phase III lung can­cer stud­ies un­der­way eval­u­at­ing Tecen­triq as a monother­a­py or in com­bi­na­tion with oth­er med­i­cines across a pletho­ra of lung can­cer types.

Tecen­triq has al­ready se­cured US ap­proval in a num­ber of lung can­cer in­di­ca­tions. In March, it scored the ex­ten­sive-stage small cell lung can­cer (ES-SCLC) ap­proval, and last De­cem­ber the FDA en­dorsed the drug in com­bi­na­tion with Avastin for pa­tients with non-squa­mous non-small cell lung can­cer. The drug — which is al­so ap­proved for blad­der and breast can­cer — raked in sales of about $788 mil­lion in the first half of this year.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. Over­all, the NSCLC mar­ket is poised to grow to $14.6 bil­lion by 2024, ac­cord­ing to Glob­al­Da­ta es­ti­mates.

The Swiss drug­mak­er is carv­ing it­self a big­ger piece of the lu­cra­tive im­muno-on­col­o­gy mar­ket, which is large­ly mo­nop­o­lized by Mer­ck’s $MRK key­stone check­point in­hibitor Keytru­da, and to a less­er ex­tent Bris­tol-My­ers Squibb $BMY Op­di­vo. As­traZeneca’s $AZN Imfinzi is al­so gain­ing ground, par­tic­u­lar­ly in lung can­cer.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.