FDA ap­proves J&J's BC­MA-tar­get­ed bis­pe­cif­ic for mul­ti­ple myelo­ma

The FDA on Tues­day grant­ed ac­cel­er­at­ed ap­proval to John­son & John­son’s Tec­vayli (teclis­tam­ab), a BC­MA-di­rect­ed bis­pe­cif­ic an­ti­body, look­ing to head in­to an al­ready crowd­ed field of treat­ments aim­ing to help those with the blood can­cer mul­ti­ple myelo­ma.

The ap­proval, which in­clud­ed a REMS due the risks of CRS and neu­ro­log­ic tox­i­c­i­ty, fol­lows promis­ing ear­ly ef­fi­ca­cy in 40 pa­tients, with 65% of pa­tients hav­ing a par­tial re­sponse or bet­ter, and fur­ther da­ta from a Phase I/II tri­al, pub­lished in the New Eng­land Jour­nal of Med­i­cine ear­li­er this month, known as Ma­jesTEC-1. Those re­sults showed that in a larg­er group of 165 pa­tients, with me­di­an fol­low-up of 14.1 months (range of 0.3 to 24.4), re­spons­es oc­curred in 104 pa­tients (63%; 95% con­fi­dence in­ter­val [CI], 55.2 to 70.4), as well as a par­tial re­sponse or bet­ter in 97 pa­tients (58.8%), and a com­plete re­sponse or bet­ter in 65 (39.4%).

The FDA said it’s the first bis­pe­cif­ic BC­MA-di­rect­ed CD3 T-cell en­gager for adult pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma who have re­ceived at least four pri­or lines of ther­a­py, in­clud­ing a pro­tea­some in­hibitor, an im­munomod­u­la­to­ry agent, and an an­ti-CD38 mon­o­clon­al an­ti­body.

Bernadette King, a J&J spokesper­son, told End­points via email that in its clin­i­cal tri­al, the av­er­age pa­tient was treat­ed for 9 to 10 months. Based on this, the to­tal cost of ther­a­py ranges be­tween a list price of $355,000 and $395,000 – or $39,500 per month.

The ap­proval fol­lows the launch of three oth­er BC­MA-tar­get­ed ther­a­pies — GSK’s ADC Blenrep, Bris­tol My­ers Squibb’s CAR-T ther­a­py Abec­ma, and J&J’s CAR-T Carvyk­ti — in myelo­ma for those who have re­ceived pri­or treat­ments in­clud­ing im­munomod­u­la­to­ry agents, pro­tea­some in­hibitors, and an­ti-CD38 an­ti­bod­ies.

Vin­cent Ra­jku­mar

“I think this is an im­por­tant ad­di­tion to treat­ment of re­lapsed re­frac­to­ry myelo­ma,” Vin­cent Ra­jku­mar, pro­fes­sor at the Mayo Clin­ic and ed­i­tor-in-chief of the Blood Can­cer Jour­nal, told End­points News. “Cur­rent­ly there are long wait­ing pe­ri­ods for CAR-T and de­lays in ad­min­is­tra­tion. The oth­er BC­MA tar­get­ed agent be­lan­tam­ab has risks of ker­atopa­thy lim­it­ing use. Teclis­tam­ab will be there­fore be very im­por­tant as a treat­ment op­tion for re­frac­to­ry dis­ease.”

But as cy­tokine re­lease syn­drome oc­curred in 72% of pa­tients in the tri­al, and 45% of pa­tients ex­pe­ri­enced grade 3 or 4 in­fec­tions, Ra­jku­mar added:

I am how­ev­er con­cerned about pro­longed week­ly ther­a­py and the risk of se­ri­ous in­fec­tions and oth­er com­pli­ca­tions it can bring along. I do not think we know the op­ti­mal dos­ing sched­ule. I sus­pect for many pa­tients we can re­duce the fre­quen­cy or stop ther­a­py once a good re­sponse is achieved.

A Phase III tri­al is on­go­ing and com­par­ing teclis­tam­ab in com­bo with dara­tu­mum­ab.

The NE­JM pub­li­ca­tion al­so laid out the var­i­ous re­sponse rates of the oth­er ther­a­pies, not­ing, “In this heav­i­ly pre­treat­ed pop­u­la­tion, the over­all re­sponse rate with be­lan­tam­ab mafodotin [Blenrep] is ap­prox­i­mate­ly 31%.5 Re­sponse rates are 67% for ide­cab­ta­gene vi­cleu­cel [Abec­ma] and 83% for cil­ta­cab­ta­gene au­toleu­cel [Carvyk­ti] in pa­tients who have un­der­gone aphere­sis; how­ev­er, CAR-T ther­a­py has lim­i­ta­tions re­gard­ing pa­tient el­i­gi­bil­i­ty, safe­ty, and ac­cess to treat­ment.”

While J&J is first to the US mar­ket (EU ap­proval came last week) with teclis­tam­ab, the BC­MA T-cell en­gager space is crowd­ed, ac­cord­ing to Eval­u­ate Phar­ma. Pfiz­er’s el­ranatam­ab ex­pects a fi­nal analy­sis from its piv­otal Mag­net­isMM-3 lat­er this year, while oth­ers in on­go­ing stud­ies in­clude Ab­b­Vie’s AB­BV-383, Re­gen­eron’s REGN5458 and Am­gen’s AMG 701.

Illustration: Assistant Editor Kathy Wong for Endpoints News

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