Adap­ti­m­mune says it's (near­ly) ready to head to the FDA with TCR can­cer ther­a­py

Six months af­ter an ini­tial re­veal at AS­CO, Adap­ti­m­mune is back in the lime­light with new da­ta Thurs­day. And the com­pa­ny be­lieves it now has enough to go to reg­u­la­tors for what would be the first-ever TCR ther­a­py.

The biotech’s afa­mi-cel pro­gram put out up­dat­ed fig­ures Thurs­day morn­ing with re­searchers not­ing as of Sept. 1, 16 of 47 pa­tients saw their tu­mors shrink while on the ex­per­i­men­tal treat­ment. It’s good enough for a 34% over­all re­sponse rate and, while low­er than the May up­date of 39%, makes Adap­ti­m­mune con­fi­dent enough to say the study will reach its pri­ma­ry end­point.

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