#ES­MO17: Eli Lil­ly sets the stage for a CDK 4/6 show­down with Pfiz­er, No­var­tis — but not ex­act­ly to its ad­van­tage

MADRID — Eli Lil­ly came to ES­MO with an eye to dis­tin­guish­ing abe­maci­clib as it pre­pares to launch its CDK 4/6 can­cer drug against ri­vals from No­var­tis and Pfiz­er. It may have done that, but not ex­act­ly as Lil­ly ex­ecs would have liked.

Cur­rent­ly un­der pri­or­i­ty re­view at the FDA, abe­maci­clib reg­is­tered the pos­i­tive da­ta need­ed to win over reg­u­la­tors in MONARCH-3. Re­searchers tracked a 46% re­duc­tion in the risk of dis­ease pro­gres­sion in the tri­al arm in­clud­ing pre­vi­ous­ly un­treat­ed women with ad­vanced breast can­cer, com­par­ing a com­bi­na­tion of abe­maci­clib added to stan­dard care. There was al­so a 59% re­sponse rate on tu­mor shrink­age com­pared to 44% in the con­trol arm pro­vid­ed stan­dard ther­a­py.

The me­di­an pro­gres­sion-free sur­vival rate and over­all sur­vival num­bers aren’t in yet.

That’s all ap­proval-wor­thy da­ta, but not nec­es­sar­i­ly the kind of ear­ly ef­fi­ca­cy re­sults that will in­tim­i­date any­one at Pfiz­er and No­var­tis wor­ried about mar­ket share.

Where it gets trou­ble­some for Eli Lil­ly, though, is on the side ef­fect da­ta.

Rates of di­ar­rhea and neu­trope­nia were 81.3% and 41.3% with abe­maci­clib, and 29.8% and 1.9% with place­bo, re­spec­tive­ly.

David Ricks, Eli Lil­ly CEO

The in­ves­ti­ga­tors are quick to say that the di­ar­rhea is typ­i­cal­ly fair­ly low grade and read­i­ly man­aged, but it’s the kind of com­mon ef­fect that could well per­suade doc­tors to pre­fer ei­ther Kisqali or Ibrance for their HR-pos­i­tive, HER2-neg­a­tive pa­tients.

That’s not the kind of dis­tin­guish­ing fac­tor you want to raise, es­pe­cial­ly when you’re late to the game.

Ever­core ISI’s Umer Raf­fat al­so sent out a note on Sun­day high­light­ing an im­bal­ance of throm­boem­bol­ic events, which could earn a warn­ing la­bel from the FDA that would give com­peti­tors a dis­tinct edge as well.

Not good.

Eli Lil­ly has as­sert­ed that it can make abe­maci­clib the best-in-class pick among the three CDK 4/6 drugs field­ed by three phar­ma gi­ants with se­ri­ous sales ef­forts. And that con­fi­dence has built peak sales es­ti­mates to close to $2 bil­lion a year. For now.

Re­searchers al­so high­light­ed new ev­i­dence that sug­gests there are pa­tient groups that would ben­e­fit more by start­ing on stan­dard ther­a­py and adding a CDK 4/6 drug as a sec­ond-line ther­a­py.

“Now for the first time,we have in­sights sug­gest­ing that pa­tients with cer­tain clin­i­cal char­ac­ter­is­tics may ben­e­fit dif­fer­ent­ly from treat­ment with a CDK 4/6 in­hibitor, in­clud­ing the pos­si­bil­i­ty that some pa­tients with a good prog­no­sis may be able to start on en­docrine ther­a­py alone,” said lead au­thor An­ge­lo Di Leo. “In such pa­tients, CDK 4/6 in­hibitors could po­ten­tial­ly be re­served as a next line of treat­ment for metasta­t­ic dis­ease. This idea war­rants fur­ther study giv­en our da­ta. In our study, near­ly one-third of pa­tients had bone metas­tases on­ly or a tu­mor re­laps­ing sev­er­al years af­ter stop­ping ad­ju­vant en­docrine ther­a­py. This is a clin­i­cal­ly rel­e­vant pro­por­tion of pa­tients for whom we may con­sid­er de­lay­ing use of a CDK 4/6 in­hibitor. This may be a more op­ti­mal treat­ment strat­e­gy for some pa­tients since it can avoid the tox­i­c­i­ty of first line CDK 4/6 in­hibitors and save costs.”

Pay­ers won’t over­look that ob­ser­va­tion.

We won’t have long to wait be­fore things heat up on the mar­ket. Lil­ly nabbed a pri­or­i­ty re­view for this drug in Ju­ly, set­ting up a fi­nal de­ci­sion by Jan­u­ary.

Lil­ly needs a steady stream of sig­nif­i­cant new drug ap­provals if new CEO Dave Ricks ex­pects to keep its in­vestors hap­py. The FDA have helped out by putting baric­i­tinib back on track, but we won’t know that for sure un­til next year.

Im­age cred­it: ES­MO

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.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? 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.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.