The post refers to an article on the value of reducing wait times associated with autologous CAR-T therapies;
"...Of 167 patients, 52 patients in our sample did not receive CAR-T infusion because of death (N = 16) or nonmortality dropout issue (N = 36) before infusion...".
The issue is indirectly addressed in the recently announced industry guidance by the FDA on considerations for the development of Car-T products. The guidance is all-encompassing but specifically refers to the issue of bridging therapy to control the active disease while patients wait for the Car-T cell treatment. There appears to be an incredible opportunity for azer-cel to become the bridging therapy of choice. First of all lets recap. The data in the Phase 1 trial demonstrated a 83% overall response rate for Car-T relapsed patients. The Phase 1b that is currently enrolling patients, is a confirmatory study in DLBCL patients relapsed after autologous Cart-T therapies. The hope is that a successful confirmatory trial will lead to a registrational trial and the first approved allogeneic Car-T therapy.
The ORR and the durability of response points to a special dynamic between the autologous Car-T and the follow-up with Azer-cel even though the patients had stopped responding to their auto Car-T possibly due to T cell exhaustion. If azer-cel is approved in the third line setting and given the pressing need to address the issue of an effective bridging therapy, could azer-cel fill the gap? The use of azer-cel will not only reduce waiting times but effectively eliminate waiting times.
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