In­cyte keeps the AS­CO spot­light fo­cused on its close­ly-watched IDO1 drug epaca­do­stat

Steven Stein

CHICA­GO — Typ­i­cal­ly, when you up­date your ear­ly-stage da­ta with a cou­ple of new com­plete re­spons­es to re­port, the bio­phar­ma world finds oth­er things to fo­cus on. But if you’re In­cyte, with a $27 bil­lion mar­ket cap $IN­CY cen­tered on its lead IDO1 ther­a­py epaca­do­stat, the bio­phar­ma world will make an ex­cep­tion for you.

So it was on Sat­ur­day at AS­CO, when In­cyte ad­just­ed the aba­cus on its non-small cell small com­bo lung can­cer study for epaca­do­stat and Keytru­da, mov­ing 2 of 14 re­spons­es re­port­ed re­cent­ly in its AS­CO ab­stract out of the par­tial side to the com­plete re­spons­es line­up.

That’s an­oth­er pos­i­tive note, and “it’s sort of a big deal in the set­ting,” In­cyte CMO Steven Stein tells me.

In­cyte is en­cour­aged by the im­prove­ment as it tracks dura­bil­i­ty of the ear­ly-stage da­ta. And while in­ves­ti­ga­tors aren’t mak­ing any pre­dic­tions of what they’re go­ing to see from here, says Stein, “it’s un­like­ly to get worse; it can on­ly get bet­ter.”

The to­tal re­sponse rate stayed the same in this study: 35%. That’s key here as the clos­est com­pa­ra­ble monother­a­py da­ta In­cyte fol­lows is an 18% and 20% re­sponse rate (for squa­mous on­ly lung can­cer) for ei­ther Keytru­da or Op­di­vo, re­spec­tive­ly.

In­cyte’s fo­cus, along with the rest of the grow­ing crowd fol­low­ing this com­pa­ny, will trans­fer now to the Phase III stud­ies that In­cyte is ham­mer­ing out with the FDA, Mer­ck and Bris­tol-My­ers Squibb.

Stein says that re­sponse rate they’ve seen could im­prove as you move up to front-line use for treat­ment naive pa­tients.

“Typ­i­cal­ly you ex­pect high­er re­sponse rates in the first-line set­ting in im­muno-on­col­o­gy,” says Stein, who fol­lowed In­cyte CEO Hervé Hop­penot out of No­var­tis On­col­o­gy to the biotech. “This has been borne out across the board as you go from first- to third-line.”

Stein is re­luc­tant to get in­to too much de­tail on how the late-stage stud­ies will play out. That has to be worked out with reg­u­la­tors. But he notes that in lung can­cer, where Mer­ck re­cent­ly won ap­proval for a land­mark Keytru­da/chemo com­bo for first-line use, you have three key pop­u­la­tions: High PD-L1 ex­pressers, low PD-L1 ex­pressers and sig­nif­i­cant­ly now all com­ers.

“We ex­pect mech­a­nis­ti­cal­ly to en­hance the check­points,” adds Stein. “Where they have largest ef­fect we would ex­pect to have our largest ef­fect and en­hance those.”

In­cyte has its own PD-1 drug, part­nered with the Chi­nese biotech Jiang­su Hen­grui Med­i­cine with a $25 mil­lion up­front and $770 mil­lion in mile­stones. But Stein says that in­ves­ti­ga­tors re­cent­ly not­ed ev­i­dence of he­man­gioma — non­cancer­ous red spots that ap­pear on the skin. It’s large­ly a “cos­met­ic” is­sue, he notes. But when there are “north of 30 pub­licly an­nounced” check­point drugs which are all sim­i­lar, it rais­es a ques­tion whether it might dif­fer­en­ti­ate the drug in a neg­a­tive way.

In­cyte is ag­nos­tic about its al­liances with the check­point lead­ers. It will fol­low the da­ta wher­ev­er they lead.

“We feel it’s im­por­tant to own one,” says Stein. “We think it will re­main a back­bone of dou­blet and maybe triplet treat­ment.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.