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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.