Lag­gard Lil­ly says its CDK 4/6 drug abe­maci­clib scored in PhI­II, while ri­vals at No­var­tis, Pfiz­er sharp­en their knives

Levi Gar­raway, Lil­ly

Just a week af­ter No­var­tis scored a key ap­proval for its CDK 4/6 can­cer drug, Eli Lil­ly is an­nounc­ing that its long-await­ed Phase III read­out for its ri­val drug abe­maci­clib looks good. We won’t get the da­ta un­til lat­er, but the phar­ma gi­ant says its MONARCH-2 tri­al comes with pos­i­tive pro­gres­sion-free da­ta on ad­vanced hor­mone-re­cep­tor-pos­i­tive, HER2 neg­a­tive breast can­cer.

In­ves­ti­ga­tors com­pared abe­maci­clib com­bined with ful­ves­trant to ful­ves­trant alone. And the da­ta set up an FDA fil­ing some­time in the next three months.

If it’s suc­cess­ful, Lil­ly will still be jump­ing in­to the CDK 4/6 game far be­hind Pfiz­er, which was first to the mar­ket with Ibrance, and No­var­tis’ ri­bo­ci­clib, now be­ing mar­ket­ed as Kisqali.

Lil­ly had been keep­ing its fin­gers crossed that it could get the pos­i­tive da­ta it need­ed in an in­ter­im analy­sis, but dis­ap­point­ed in­vestors last sum­mer with the news that it would need to go all the way to the end. Now, with a break­through drug des­ig­na­tion, Lil­ly will do every­thing it can to cut the re­view cy­cle short so it can hit the mar­ket AS­AP.

But its late ar­rival could car­ry a heavy penal­ty.

Ac­cord­ing to the key tri­al de­sign, Lil­ly’s drug was re­strict­ed to pa­tients who have not pre­vi­ous­ly been treat­ed with a CDK 4/6 drug. If that makes its way to the la­bel, Lil­ly’s treat­ment would not be al­lowed for any pa­tient who had been treat­ed with ei­ther Pfiz­er’s Ibrance or No­var­tis’s ri­bo­ci­clib (LEE011). And with both of those drugs on the mar­ket ahead of Lil­ly, that could sig­nif­i­cant­ly shrink its mar­ket reach.

Leerink’s Sea­mus Fer­nan­dez fleshed out Lil­ly’s time­line this morn­ing, in­clud­ing a like­ly AS­CO pre­sen­ta­tion, af­ter talk­ing to ex­ecs. He not­ed:

The com­pa­ny has the “da­ta pack­age ready to go” and will sub­mit an NDA for sin­gle-agent abe­maci­clib in 2Q17 based on the MONARCH-1 study; the pack­age will in­clude da­ta on re­sponse rate (RR), PFS and OS (over­all sur­vival). An ad­di­tion­al ap­pli­ca­tion sub­mis­sion for MONARCH-2 is ex­pect­ed in 3Q17. Mgmt al­so con­firmed that the MONARCH-3 study, which is in com­bi­na­tion with letro­zole, is ex­pect­ed to have an in­ter­im analy­sis in 2Q and the fi­nal read­out is ex­pect­ed be­fore the end of 2017.

“We are ex­cit­ed about the out­come of our first Phase III study for abe­maci­clib. These da­ta are an im­por­tant mile­stone in our goal of bring­ing abe­maci­clib to pa­tients with ad­vanced breast can­cer, and we look for­ward to our up­com­ing con­ver­sa­tions with reg­u­la­tors,” said Levi Gar­raway, SVP, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “This is an­oth­er ex­am­ple of Lil­ly’s com­mit­ment to de­liv­er­ing break­through treat­ments and im­prov­ing out­comes for pa­tients with can­cer.”

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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As­traZeneca scores new goal on the pipeline front, adding its first AI-gen­er­at­ed tar­get to the port­fo­lio

As more and more biopharmas develop artificial intelligence platforms, the drug discovery process is being reshaped to fit new goals on cutting down the prodigious amount of time, energy and money that go into a drug program. Now one of the most ambitious players in the drive to improve on ROI, AstraZeneca, is marking a milestone on that front by adding the first target generated by AI to its portfolio.

Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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