#ASCO21: Takeda fleshes out case for oral EGFR drug with follow-up pivotal data in non-small cell lung cancer - Endpoints News

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Take­da is look­ing to carve out a ma­jor niche in non-small cell lung can­cer with an oral TKI in­hibitor tar­get­ing a rare but des­per­ate pa­tient pop­u­la­tion. Now, with the FDA al­ready check­ing its math, Take­da is un­veil­ing up­dat­ed da­ta adding even more heft to that drug’s case.

Take­da’s mobo­cer­tinib post­ed a me­di­an OS of 24 months at a 14-month fol­low-up in pa­tients with EGFR Ex­on20 in­ser­tion mu­ta­tion-pos­i­tive, metasta­t­ic NSCLC who re­ceived pri­or plat­inum-based chemother­a­py, ac­cord­ing to fol­low-up da­ta from a Phase I/II study set to be pre­sent­ed at AS­CO in June.

The re­sults fol­low up topline da­ta pre­sent­ed in Jan­u­ary show­ing mobo­cer­tinib hit an ORR of 35% as judged by the tri­al’s in­ves­ti­ga­tors and 28% from an in­de­pen­dent da­ta re­view com­mit­tee. The drug al­so showed a me­di­an du­ra­tion of re­sponse of 17.5 months — both in­ves­ti­ga­tors and the DRC agreed on that fig­ure — and pro­gres­sion-free sur­vival of 7.3 months.

The pooled re­sults show promise for ex­on 20-pos­i­tive pa­tients, who make up about 10% of the to­tal EGFR NSCLC pop­u­la­tion and have a par­tic­u­lar­ly poor prog­no­sis. It’s a small pop­u­la­tion but one with a high un­met clin­i­cal need.

The FDA grant­ed a pri­or­i­ty re­view for the oral drug in that pop­u­la­tion late last month with a re­view date set for Oct. 26. The OS da­ta were in­clud­ed in Take­da’s ap­pli­ca­tion and will be re­viewed as part of the reg­u­la­to­ry ap­proval process.

There was one ma­jor red flag on mobo­cer­tinib’s record in the Phase I/II test — a high rate of se­vere di­ar­rhea in tri­al pa­tients, enough so that they in­sti­tut­ed a di­ar­rhea man­age­ment pro­to­col for pa­tients in the Phase I por­tion of the tri­al and con­tin­ued in the Phase II ex­pan­sion. In all, di­ar­rhea was re­port­ed in 91% of all pa­tients with se­vere side ef­fects, fol­lowed by rash at 45%.

Even with the guide­lines in place, the vast ma­jor­i­ty of pa­tients with se­vere side ef­fects re­port­ed di­ar­rhea, like­ly in­di­cat­ing an even high­er rate of di­ar­rhea in pa­tients who didn’t re­ceive the pro­to­col.

When asked to clar­i­fy in Jan­u­ary the rate of di­ar­rhea in pa­tients pri­or to those guide­lines be­ing put in place, Take­da’s head of on­col­o­gy Chris Arendt “cau­tion(ed) a lit­tle bit in terms of over-in­ter­pret­ing” and said the pro­to­col was de­signed to be “avail­able to pa­tients and not oner­ous.” The drug­mak­er plans to present fur­ther de­tails on those guide­lines at a lat­er date, Arendt said at the time, and not­ed that se­vere di­ar­rhea is com­mon in ex­on 20-pos­i­tive pa­tients af­ter chemo.

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