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As­traZeneca's can­cer com­bo wins sec­ond nod in one month, this time in lung can­cer

Weeks af­ter cel­e­brat­ing the first can­cer win for its Imfinzi and Imju­do duo, As­traZeneca is once again break­ing out the par­ty hats.

The mon­o­clon­al an­ti­body com­bo scored a la­bel ex­pan­sion on Thurs­day in metasta­t­ic non-small cell lung can­cer (NSCLC) along­side plat­inum-based chemother­a­py. Just last month, the drugs won a nod in un­re­sectable he­pa­to­cel­lu­lar car­ci­no­ma (HCC), the most com­mon type of liv­er can­cer.

As­traZeneca spent years search­ing for the right dos­ing reg­i­men for Imju­do be­fore it was fi­nal­ly ap­proved just last month, join­ing Bris­tol My­ers Squibb’s Yer­voy as the on­ly FDA-cleared CT­LA-4 drugs. The new in­di­ca­tion gives Imfinzi and Imju­do ac­cess to a ma­jor — but crowd­ed — mar­ket.

Lung can­cer is the sec­ond most com­mon­ly di­ag­nosed type in the US, ac­cord­ing to As­traZeneca, and NSCLC car­ries a par­tic­u­lar­ly poor prog­no­sis. How­ev­er, Mer­ck’s multi­bil­lion dol­lar PD-1 ther­a­py Keytru­da has a tight grip on the mar­ket, and oth­er ri­vals such as Bris­tol My­ers Squibb’s Op­di­vo and Roche’s Tecen­triq put up a tough fight.

Ear­li­er this week, Re­gen­eron’s PD-(L) in­hibitor Lib­tayo won ap­proval in com­bi­na­tion with chemother­a­py as a front­line treat­ment for adult pa­tients with ad­vanced non-small cell lung can­cer with no EGFR, ALK or ROS1 aber­ra­tions.

Imfinzi and Imju­do are ap­proved to treat metasta­t­ic NSCLC pa­tients who have no sen­si­tiz­ing epi­der­mal growth fac­tor re­cep­tor (EGFR) mu­ta­tion or anaplas­tic lym­phoma ki­nase (ALK) ge­nom­ic tu­mor aber­ra­tions.

Imju­do was li­censed to As­traZeneca by Pfiz­er in 2011, fol­low­ing some dis­ap­point­ing ear­ly re­sults. While As­traZeneca has since post­ed its own fair share of flops, the lat­est ap­proval is based on da­ta from the suc­cess­ful PO­SEI­DON tri­al, which showed that Imfinzi and Imju­do com­bined with chemo and main­te­nance ther­a­py achieved a me­di­an over­all sur­vival of 14 months com­pared to 11.7 months in pa­tients on chemother­a­py alone fol­lowed by main­te­nance ther­a­py (p= 0.00304). Me­di­an pro­gres­sion-free sur­vival was 6.2 months and 4.8 months, re­spec­tive­ly (p= 0.00031).

The most com­mon ad­verse events were nau­sea, fa­tigue, de­creased ap­petite, mus­cu­loskele­tal pain, rash and di­ar­rhea, ac­cord­ing to the FDA.

“This ap­proval un­der­scores the im­por­tance of de­liv­er­ing nov­el treat­ment com­bi­na­tions that ex­tend sur­vival in metasta­t­ic non-small cell lung can­cer, a com­plex set­ting where many pa­tients still face a dis­mal prog­no­sis,” Dave Fredrick­son, ex­ec­u­tive VP of As­traZeneca’s on­col­o­gy busi­ness unit, said in a state­ment. The com­pa­ny was not im­me­di­ate­ly avail­able for an in­ter­view.

As­traZeneca says it’s still wait­ing to hear from reg­u­la­tors in Eu­rope, Japan and oth­er coun­tries.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”