[GUIDE] SpringWorks and Seagen team up in multiple myeloma; Merck and Eisai build out Keytruda/Lenvima data – Endpoints News – Avis

Spring­Works has a new col­lab­o­ra­tion, and it’s one with a promi­nent phar­ma part­ner.

The Con­necti­cut biotech is team­ing up with Seagen on a new clin­i­cal tri­al to eval­u­ate the com­pa­ny’s gam­ma sec­re­tase in­hibitor nirogace­s­tat with SEA-BC­MA. Seagen’s can­di­date is a mon­o­clon­al an­ti­body tar­get­ing BC­MA, and the com­bo will look at pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma.

The duo not­ed in a re­lease that “gam­ma sec­re­tase in­hi­bi­tion pre­vents the cleav­age and shed­ding of BC­MA from the sur­face of myelo­ma cells,” like­ly prov­ing the im­pe­tus for the deal. Un­der the deal, Seagen will spon­sor and con­duct the Phase I study ex­pect­ed to be­gin be­fore the end of 2021.

No fi­nan­cial terms were dis­closed, though Seagen will be man­ag­ing all costs re­lat­ed to the tri­al.

Mer­ck and Ei­sai build out Keytru­da/Lenvi­ma da­ta

Mer­ck and Ei­sai re­vealed new Phase III da­ta for their Keytru­da and Lenvi­ma com­bi­na­tion in first-line ad­vanced re­nal cell car­ci­no­ma, cur­rent­ly be­fore the FDA for re­view.

In an analy­sis of a sec­ondary end­point from pa­tient-re­port­ed qual­i­ty of life sur­veys, the com­bo demon­strat­ed sim­i­lar changes from base­line in 14 out of 18 evalu­able symp­toms and bet­ter scores in the rest af­ter an av­er­age fol­low-up of 46 weeks, com­pared to the suni­tinib con­trol. The ar­eas where the com­bo showed im­prove­ment were fa­tigue, la­bored breath­ing, phys­i­cal func­tion­ing and con­sti­pa­tion.

“This analy­sis ad­dress­es ques­tions of in­ter­est to health­care pro­fes­sion­als who treat pa­tients with ad­vanced re­nal cell car­ci­no­ma,” Takashi Owa, chief med­i­cine cre­ation of­fi­cer at Ei­sai’s on­col­o­gy di­vi­sion, said in a state­ment.

Reg­u­la­tors grant­ed the com­bo a pri­or­i­ty re­view last month. The PDU­FA dates are slat­ed for Au­gust 25 and 26 for the ad­vanced RCC sN­DA and sBLA ap­pli­ca­tions, re­spec­tive­ly, and Sep­tem­ber 3 for ad­vanced en­dome­tri­al car­ci­no­ma.

[GUIDE] SpringWorks and Seagen team up in multiple myeloma; Merck and Eisai build out Keytruda/Lenvima data – Endpoints News – Avis
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