Months af­ter Imfinzi com­bo flops, As­traZeneca wins NICE en­dorse­ment as lung can­cer monother­a­py

As­traZeneca’s big bet on a com­bi­na­tion of its check­point in­hibitor Imfinzi and in-house CT­LA-4 drug has proved ex­ceed­ing­ly cost­ly, but the British drug­mak­er has some­thing to cheer about as its PD-L1 in­hibitor made the NICE cut for use in cer­tain NHS pa­tients with non-small-cell lung can­cer, the largest, most lu­cra­tive field of on­col­o­gy.

The drug will be made avail­able by NHS Eng­land for pa­tients with lo­cal­ly ad­vanced un­re­sectable non-small-cell lung can­cer who have been treat­ed with plat­inum-based chemora­di­a­tion. It was ap­proved last Sep­tem­ber by the Eu­ro­pean Com­mis­sion as the on­ly im­munother­a­py to notch the nod in this pa­tient pop­u­la­tion, giv­ing it an edge over Mer­ck’s trail­blaz­ing check­point in­hibitor Keytru­da.

Known chem­i­cal­ly as dur­val­um­ab, Imfinzi was ap­proved on the ba­sis of da­ta from the Phase III PA­CIF­IC tri­al that showed the drug in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival by 11.2 months ver­sus place­bo, and al­so helped pa­tients live longer. Cur­rent­ly there are no oth­er treat­ment op­tions for these pa­tients whose dis­ease has not pro­gressed post chemora­di­a­tion, NICE not­ed.

The drug is ad­min­is­tered as an in­tra­venous in­fu­sion every two weeks, un­til dis­ease pro­gres­sion or for up to 12 months. A 500 mg vial has a list price of £2,466 but un­der NICE’s agree­ment As­traZeneca will pro­vide it to the NHS at a con­fi­den­tial dis­count­ed price, NICE said.

Al­though the drug has the “po­ten­tial to be cu­ra­tive”, there is a high lev­el of un­cer­tain­ty un­der­ly­ing its clin­i­cal ev­i­dence, so NICE has rec­om­mend­ed its use with­in the Can­cer Drugs Fund — a fund that aims to make promis­ing can­cer drugs avail­able to pa­tients be­fore they are ful­ly sanc­tioned for use in the NHS — while more da­ta are col­lect­ed.

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. Lung can­cer has a poor prog­no­sis; sta­tis­tics sug­gest over half of peo­ple di­ag­nosed die with­in one year of di­ag­no­sis and the av­er­age 5-year over­all sur­vival rate is less than 18%. NICE said Imfinzi con­sti­tut­ed a ‘big ad­vance’ as it was plau­si­ble that be­tween 27% and 40% of peo­ple tak­ing dur­val­um­ab would have 5 years of pro­gres­sion-free sur­vival.

In the fi­nal months of last year, As­traZeneca’s plan to ex­pand the use of Imfinzi by com­bin­ing it with its CT­LA-4 treme­li­mum­ab  — once tout­ed as the cor­ner­stone of the drug­mak­er’s check­point de­vel­op­ment strat­e­gy — failed to help cer­tain pa­tients with head and neck can­cer, in ad­di­tion to the big flop in the keen­ly-watched MYS­TIC lung can­cer tri­al.

Imfinzi gen­er­at­ed 2018 sales of $633 mil­lion for As­traZeneca.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by set­back with a fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Sanofi protests, AP Images

Paul Hud­son faces down French unions in fight to re­struc­ture Sanofi

Sanofi CEO Paul Hudson is facing a familiar adversary in his efforts to cut up to 1,680 jobs from the French pharma giant: French unions.

Around 200 union members staged a one-day strike Tuesday at Sanofi’s main Covid-19 vaccine plant in Marcy-l’Étoile to protest the cuts, The Associated Press reported, with other members joining at other facilities across the country.

France’s finance minister Bruno Le Maire, meanwhile, went on French radio twice this week to talk about the company. On Monday, per Reuters, he told RTL that Sanofi would not close any plants or lay off any employees in the restructuring. But on Wednesday morning, he re-emerged on BFM and said he would like three things from the drugmaker, including confirmation that there will be no site closures and layoffs.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.

Covid-19 claims an­oth­er PDU­FA vic­tim as Glax­o­SmithK­line push­es back planned PD-1 roll­out

Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Ugur Sahin, BioNTech CEO (AP Images)

Covid-19 roundup: BioN­Tech of­fers da­ta show­ing Pfiz­er-part­nered vac­cine pro­tects against vari­ant; No­vavax at­trib­ut­es re­spon­si­bil­i­ty for PhI­II de­lay to OWS

Ugur Sahin and his team at BioNTech have proffered more evidence that their Pfizer-partnered Covid-19 vaccine can protect people from a much-feared variant of SARS-CoV-2.

Colloquially known as the UK variant, the B.1.1.7 lineage triggered alarms because it appeared more transmissible. Among a series of mutations on its spike protein — the key antigen that all frontrunners in the vaccine race targeted — N501Y was of particular concern because it’s located on the receptor-binding site.

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