#AS­CO21: J&J busts out a small up­date for its an­ti­body-TKI com­bo in lung can­cer — whet­ting ap­petites as FDA thinks it over

In a red-hot EGFR-mu­tat­ed non-small cell lung can­cer mar­ket, John­son & John­son thinks it could have a leader in its bis­pe­cif­ic an­ti­body ami­van­tam­ab. But as com­peti­tors crowd in, J&J is look­ing to back up its case for ap­proval, and it’s rolling out just a taste of that da­ta to back its case in rare mu­ta­tions.

A com­bi­na­tion of J&J’s EGFR/MET bis­pe­cif­ic an­ti­body ami­van­tam­ab and small-mol­e­cule TKI drug laz­er­tinib post­ed a me­di­an du­ra­tion of re­sponse of 9.6 months in pa­tients with NSCLC with ex­on 19 dele­tion or L858R mu­ta­tion that hadn’t pre­vi­ous­ly un­der­gone chemo but pre­vi­ous­ly failed on As­traZeneca’s Tagris­so, ac­cord­ing to co­hort da­ta from the Phase I/II CHRYSALIS study set to be pre­sent­ed at AS­CO.

It’s a mea­ger up­date for J&J’s com­bo af­ter the drugs post­ed a 100% com­plete re­sponse — and whet in­vestors’ ap­petites — at last year’s ES­MO for EGFR-mu­tat­ed NSCLC pa­tients who were treat­ment-naive. In the re­lapsed set­ting, a 45-pa­tient co­hort hit a 36% con­firmed re­sponse rate with 1 com­plete re­sponse and 15 par­tial.

The drug­mak­er filed for ap­proval in the broad­er pa­tient pop­u­la­tion back in De­cem­ber.

Pa­tients in this com­bo co­hort were al­so ge­net­i­cal­ly test­ed for EGFR- or MET-based tu­mor re­sis­tance, with 17 pa­tients iden­ti­fied as hav­ing one or both re­sis­tance mech­a­nisms. Of those, the over­all re­sponse rate was 47% — high­er than the com­bo co­hort on the whole — with a me­di­an du­ra­tion of re­sponse of 10.4 months. The clin­i­cal ben­e­fit re­sponse rate was 82% with a me­di­an PFS of 6.7 months.

Even more im­pres­sive, for the 10 pa­tients in the co­hort whose tu­mors stained high for both MET and EGFR, the over­all re­sponse rate was 90%. The com­pa­ny said it planned to lean on ge­net­ic test­ing in or­der to lo­cate pa­tients with the high­est chance of ben­e­fit­ting from the ami­van­tam­ab-laz­er­tinib com­bo in the Phase III MARI­POSA study cur­rent­ly on­go­ing.

J&J is pri­mar­i­ly set­ting up ami­van­tam­ab for ex­on 20 mu­ta­tions, which have few treat­ment op­tions and have be­come some­what of an arms race for Big Phar­ma. On Wednes­day, Take­da rolled out its own da­ta set for a next-gen TKI in­hibitor look­ing at the same pop­u­la­tion.

Look­ing at the bat­tle against ap­proved and po­ten­tial TKI head-on, J&J al­so rolled out “in­di­rect treat­ment com­par­i­son” show­ing the drug post­ed a 10-month high­er OS com­pared with pa­tients treat­ed with re­al-world ther­a­pies such as TKIs and check­point in­hibitors. It’s all part of an ef­fort, J&J said, to high­light the huge un­met clin­i­cal need in NSCLC that oth­er play­ers haven’t been able to meet.

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.

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.

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.

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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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.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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