Em­bold­ened by AS­CO da­ta, FDA etch­es speedy ap­proval path for Io­vance's cer­vi­cal can­cer ther­a­py

Io­vance’s promis­ing da­ta snap­shot de­tail­ing the po­ten­tial of its cer­vi­cal can­cer drug at AS­CO has con­vinced the FDA to ac­cel­er­ate its path to ap­proval.

On Tues­day, the drug de­vel­op­er said the US reg­u­la­tor has rec­om­mend­ed that an on­go­ing mid-stage study of its ex­per­i­men­tal ther­a­py may be suf­fi­cient to sup­port an ap­pli­ca­tion to mar­ket LN-145 in pa­tients with ad­vanced cer­vi­cal can­cer.

Maria Fardis LinkedIn

“This feed­back is en­cour­ag­ing. The abil­i­ty to use the cur­rent study, as well as the Break­through Ther­a­py des­ig­na­tion re­cent­ly grant­ed to LN-145, al­lows us to plan on a path to BLA sub­mis­sion in the sec­ond half of 2020,” Io­vance chief Maria Fardis said in a state­ment. The com­pa­ny’s shares climbed about 2.6% to $25.26 be­fore the bell.

In or­der to sup­port the ap­pli­ca­tion to mar­ket the bi­o­log­ic, Io­vance will need to en­roll be­tween 75 to 100 pa­tients in the on­go­ing tri­al, the Cal­i­for­nia-based com­pa­ny said. The es­ti­mat­ed en­roll­ment of the study, called in­no­vaTIL-04, pri­or to the FDA meet­ing was 59 pa­tients, ac­cord­ing to the clin­i­cal­tri­als.gov data­base.

Jef­feries an­a­lysts pre­dict­ed the com­pa­ny will need about 6 months of fol­low-up af­ter en­rolling the last pa­tient and sug­gest­ed that Io­vance could file with 75 pa­tients in the mid­dle of 2020 and with 100 pa­tients by the fourth quar­ter. “We be­lieve IO­VA could file based on 75 pa­tients giv­en Keytru­da re­ceived ac­cel­er­at­ed ap­proval in ad­vanced cer­vi­cal can­cer based on a PII tri­al en­rolling 77 pa­tients.”

In May, Io­vance gar­nered en­thu­si­asm af­ter it re­port­ed da­ta from 27 evalu­able cas­es of ad­vanced cer­vi­cal can­cer. The biotech­nol­o­gy com­pa­ny’s tu­mor in­fil­trat­ing lym­pho­cyte (TIL) ther­a­py in­duced a 44% ob­jec­tive re­sponse rate (ORR) — in­clud­ing one com­plete re­sponse, 9 par­tial re­sponse and two un­con­firmed par­tial re­spons­es. Mer­ck’s Keytru­da — the cur­rent stan­dard of care in this pa­tient pop­u­la­tion — was ap­proved as a sec­ond-line cer­vi­cal can­cer ther­a­py with a 14% ORR.

Jef­feries’ Biren Amin es­ti­mat­ed peak sales of $382 mil­lion for LN-145 by 2030 based on about 4600 sec­ond-line ad­vanced cer­vi­cal can­cer pa­tients and 50% mar­ket pen­e­tra­tion, us­ing a con­ser­v­a­tive per year price of ~$250,000 per pa­tient (and no an­nu­al price in­creas­es).

Boris Peak­er Cowen

LN-145 is al­so be­ing test­ed for use in head and neck can­cer.

In the ear­ly stages of can­cer, the im­mune sys­tem at­tacks its preda­tor by mo­bi­liz­ing lym­pho­cytes to at­tack and in­fil­trate the tu­mor. How­ev­er, the de­fen­sive abil­i­ty of these tu­mor-in­fil­trat­ing lym­pho­cytes (TILs) is typ­i­cal­ly brief as can­cer cells quick­ly mu­tate, evad­ing de­tec­tion. Io­vance’s tech­nol­o­gy is en­gi­neered to un­sheath the cloak of in­vis­i­bil­i­ty worn by can­cer cells to su­per­charge TIL ef­fi­ca­cy. The com­pa­ny first ex­tracts TILs from the pa­tient and ex­pands them in a lab to the tune of bil­lions. The am­pli­fi­ca­tion process elim­i­nates the im­mune-sup­pres­sive en­vi­ron­ment cre­at­ed by the tu­mor and en­hances the repli­ca­tion and ac­ti­va­tion of ag­gres­sive an­ti-tu­mor TIL. Once a sur­feit of TILs has been cul­tured, the cells are re-in­fused in­to the pa­tient.

Da­ta pre­sent­ed at AS­CO from an­oth­er study showed Io­vance’s lead ex­per­i­men­tal ther­a­py, li­fileu­cel, con­ferred an ORR of 38% (2 com­plete re­spons­es and 23 par­tial re­spons­es) in 66 con­sec­u­tive­ly dosed post-PD-1 pa­tients with late-stage un­re­sectable melanoma.

Io­vance’s an­nounce­ment on Tues­day is pos­i­tive, but “large­ly in­line with in­vestor ex­pec­ta­tions post AS­CO. This al­so ex­pe­dites that cer­vi­cal can­cer time­lines in­line with the melanoma study, both of which are now ex­pect­ed to re­port fi­nal re­sults and BLA fil­ing in 2H20,” Cowen’s Boris Peak­er wrote in a note.

So­cial im­age: An­drew Harnik, AP Im­ages

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