Novo­cure bags mesothe­lioma nod for elec­tric fields can­cer ther­a­py with some lim­i­ta­tions

Mary Hes­dorf­fer Mesothe­lioma Ap­plied Re­search Foun­da­tion

Novo­cure has se­cured the FDA’s bless­ing for an­oth­er use of its tu­mor treat­ing fields: ma­lig­nant pleur­al mesothe­lioma, a rare can­cer that de­vel­ops in the lin­ings of the lung and chest.

The NovoT­TF-100L Sys­tem is to be de­ployed with Eli Lil­ly’s Al­im­ta (peme­trexed) and a plat­inum-based chemother­a­py in the first-line treat­ment of un­re­sectable, lo­cal­ly ad­vanced or metasta­t­ic forms of the dis­ease. Cur­rent­ly, on­ly 10% to 20% of MPM pa­tients are can­di­dates for surgery to re­move the tu­mor, ac­cord­ing to Mary Hes­dorf­fer of the Mesothe­lioma Ap­plied Re­search Foun­da­tion.

It marks the sec­ond ap­proved use for the elec­tric fields sys­tem pi­o­neered by founder Yoram Palti, pro­fes­sor emer­i­tus of phys­i­ol­o­gy and bio­physics at the Is­rael In­sti­tute of Tech­nol­o­gy since Novo­cure be­gan treat­ing glioblas­toma pa­tient with the tech in 2011. That ther­a­py, Op­tune, is sub­ject of a part­ner­ship deal with Chi­na’s Zai Lab.

Yoram Palti Novo­cure

No­tably, though, for the new OK, reg­u­la­tors went through the hu­man­i­tar­i­an de­vice ex­emp­tion path­way, which car­ries no re­quire­ment for ev­i­dence of ef­fec­tive­ness.

Novo­cure, though, is ea­ger to show­case how their treat­ment — which fea­tures elec­tric fields tuned to spe­cif­ic fre­quen­cies to dis­rupt sol­id tu­mor cell di­vi­sion — can ex­tend sur­vivals in some of the more ag­gres­sive forms of can­cer.

In a sin­gle-arm tri­al with 80 pa­tients, NovoT­TF-100L plus chemo achieved a me­di­an over­all sur­vival of 18.2 months with­out in­creas­ing se­ri­ous ad­verse events, com­pared to 12.1 months in the his­tor­i­cal con­trol.

Bill Doyle Novo­cure

“FDA ap­proval of NovoT­TF-100L pro­vides pa­tients with the first FDA-ap­proved treat­ment for MPM in more than 15 years and, as our first FDA-ap­proved tor­so can­cer in­di­ca­tion, marks a ma­jor mile­stone for Novo­cure,” Bill Doyle, Novo­cure’s ex­ec­u­tive chair­man.

While lim­it­ed in the quan­ti­ty it can dis­trib­ute due to its hu­man­i­tar­i­an de­vice sta­tus, the new com­mer­cial­iza­tion dri­ve will like­ly al­so go some way in so­lid­i­fy­ing its fi­nan­cial op­er­a­tion af­ter it ob­tained a $150 mil­lion term loan from Bio­Phar­ma Cred­it last Feb­ru­ary, most­ly to re­pay an ex­ist­ing debt but al­so to fund work­ing cap­i­tal.

Im­age: Kristof­fer Trip­plaar for Sipa USA. AP

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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