For­get Bris­tol-My­ers: Re­gen­eron takes on Mer­ck for the heavy­weight ti­tle in non-small cell lung can­cer

Re­gen­eron may have been the 6th bio­phar­ma com­pa­ny to land an ini­tial ap­proval for a PD-1/L1 ther­a­py, but they’re clear­ly not set­tling for any­thing close to a last-place fin­ish in the amaz­ing race for mar­ket dom­i­nance in the mega-block­buster field.

In their Q4 call with an­a­lysts on Thurs­day, Re­gen­eron’s not-shy R&D chief George Yan­copou­los tout­ed their cap­ture of the lead role among check­points in treat­ing ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma. In an in­ter­view with End­points News last month, Yan­copou­los made so se­cret of his opin­ions about the PD-L1s on the mar­ket, slam­ming them all as sec­ond-rate and as­sign­ing worst-in-class sta­tus to Baven­cio from Pfiz­er and Mer­ck KGaA. But they’re al­so mov­ing to chal­lenge gi­ant Mer­ck’s Keytru­da — an­oth­er PD-1 — on one of its ma­jor achieve­ments: win­ning an OK as a monother­a­py for front­line use in non-small cell lung can­cer.

Here’s Yan­copou­los from the call on his I/O strat­e­gy:

(W)e have dou­bled the size of our tri­al com­par­ing Lib­tayo monother­a­py to chemother­a­py in PD-L1-high pa­tients. Re­gard­ing com­bi­na­tions, we’ll be fo­cus­ing our ef­forts in first-line treat­ing and com­bi­na­tion ther­a­py of Lib­tayo with chemother­a­py. The on­go­ing Phase III com­bi­na­tion study is be­ing aug­ment­ed to en­roll non-small cell lung can­cer pa­tients ir­re­spec­tive of his­tol­ogy and the lev­els of PD-L1 ex­pres­sion and to ran­dom­ize to Lib­tayo plus chemother­a­py or chemother­a­py alone.

Amaz­ing­ly enough de­spite the years of ef­fort in many piv­otal tri­als there’s on­ly one PD-1 or PD-L1 an­ti­body ap­proved as monother­a­py in first-line metasta­t­ic non-small cell lung can­cer (Keytru­da). If our on­go­ing tri­als suc­ceed, we have the po­ten­tial to be the sec­ond.

Bris­tol-My­ers Squibb — which so far has pro­vid­ed Keytru­da its biggest chal­lenge with Op­di­vo — has been work­ing hard to over­come Mer­ck’s move to the top of the mar­ket, fo­cus­ing on a tu­mor mu­ta­tion­al bur­den ap­proach that has failed to gain much trac­tion.

Yan­copou­los was al­so quick to tout Re­gen­eron’s bis­pe­cif­ic strat­e­gy, fo­cus­ing on: “the CD3 bis­pecifics and the cos­tim­u­la­to­ry bis­pecifics. We be­lieve that these bis­pecifics may have im­por­tant an­ti­cancer ac­tiv­i­ty on their own and in com­bi­na­tions that can in­clude Lib­tayo.… Many of our CD3 bis­pecifics are al­ready in the clin­ic with one of them show­ing im­pres­sive ini­tial re­sults as a monother­a­py in very-ad­vanced late-stage pa­tients.”

“REGN1979 our CD20xCD3 bis­pe­cif­ic for B-cell Non-Hodgkin’s Lym­phoma or NHL” has achieved im­pres­sive re­sults, he not­ed, adding:

(O)ur BC­MAx­CD3 bis­pe­cif­ic an­ti­body has just en­tered clin­i­cal de­vel­op­ment for the treat­ment of mul­ti­ple myelo­ma. We’re en­cour­aged by pre­lim­i­nary re­sults of both CAR-T as well as BiTEs tar­get­ing BC­MA in mul­ti­ple myelo­ma and be­lieve that our BC­MAx­CD3 bis­pe­cif­ic has a po­ten­tial of be­ing an im­por­tant ad­di­tion in this new area.

“It’s us against the world,” Yan­copou­los told me in a meet­ing at JP Mor­gan. And the Re­gen­eron re­search chief gives the com­pa­ny good odds at win­ning, cit­ing his clear be­lief that the com­pa­ny has the best tech­nol­o­gy and drugs in hand to slam dunk the com­pe­ti­tion.


Im­age: George Yan­copou­los. GET­TY IM­AGES

John Hood [file photo]

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CEO Pascal Soriot via Getty Images

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