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.”

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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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