EMA wants docs to stop pre­scrib­ing Eli Lil­ly’s can­cer drug Lartru­vo — and here's why

Just a few days af­ter Eli Lil­ly’s em­bar­rass­ing ad­mis­sion that its quick-to-mar­ket soft tis­sue sar­co­ma drug Lartru­vo (olara­tum­ab) flopped in a Phase III con­fir­ma­to­ry study, Eu­ro­pean reg­u­la­tors are rec­om­mend­ing that doc­tors find some oth­er drug to use against the dis­ease. 

Ac­cord­ing to the reg­u­la­tors, the drug com­bined with dox­oru­bicin bare­ly edged out dox­oru­bicin alone, not close to a sta­tis­ti­cal­ly sig­nif­i­cant out­come. Over­all sur­vival was 20.4 months for the com­bo ver­sus 19.7 months for dox­oru­bicin, with a dis­mal haz­ard ra­tio of 1.05. Chemo alone ac­tu­al­ly edged out the com­bo in pro­gres­sion-free sur­vival; 6.8 months com­pared to 5.4 months.

Launched in 2016, the EMA says that af­ter top-line da­ta un­der­scored the drug’s fail­ure to im­prove ei­ther pro­gres­sion-free or over­all sur­vival rates, no new pa­tients should get this ther­a­py. Eli Lil­ly $LLY said at the end of last week that it is end­ing pro­mo­tions on the drug and an­a­lysts are us­ing it as a test case, wait­ing to see if the FDA will fol­low through and for­mal­ly yank it off the mar­ket.

The EMA added that reg­u­la­tors want physi­cians to re­view cas­es on about 1,000 pa­tients tak­ing the drug, and stop its use un­less they be­lieve it’s pro­vid­ing a ben­e­fit. That opin­ion is cer­tain to quick­ly chill the ex­ist­ing mar­ket on both sides of the At­lantic.

Lartru­vo’s ap­proval was based on Phase II da­ta, a now-pop­u­lar strat­e­gy that has ac­cel­er­at­ed the OK on scores of on­col­o­gy drugs. Even with the transat­lantic set­back for Lil­ly, which has been work­ing to build some mo­men­tum in its can­cer di­vi­sion with the re­cent $8 bil­lion Loxo buy­out, the fail­ure in Phase III is un­like­ly to blunt the FDA’s ped­al-to-the-medal ap­proach on can­cer drug re­views. 

Un­less, of course, the gov­ern­ment shut­down forces the FDA to slow and stop.

It was a dif­fer­ent sto­ry back in the fall of 2016, when the FDA first OK’d the drug — the first new ther­a­py for soft tis­sue sar­co­ma in 40 years. The drug tar­gets PDGF re­cep­tors which are linked to tu­mor growth.

Lil­ly, which has be­gun to rack up a few new drug ap­provals af­ter a long drought in the clin­ic, was able to present phase II stats show­ing that the me­di­an sur­vival rate for pa­tients tak­ing olara­tum­ab hit 26.5 months for the com­bo com­pared to 14.7 months for pa­tients who re­ceived dox­oru­bicin alone. In­ves­ti­ga­tors al­so post­ed a me­di­an pro­gres­sion-free sur­vival time of 8.2 months for the com­bo com­pared to 4.4 months for pa­tients who re­ceived on­ly dox­oru­bicin. Tu­mor shrink­age reg­is­tered at 18.2 per­cent against 7.5 per­cent.

Clin­i­cal­tri­als.gov lists 5 on­go­ing stud­ies for the drug.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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UP­DAT­ED: Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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