Table 3.
IRC-assessed efficacy results in relapsed or refractory FL.
| Outcome | Result | |
|---|---|---|
| Primary efficacy population (N = 81) | All leukapheresed (N = 123)d | |
| Best overall response, n (%) | ||
| Objective response | 74 (91%) | 110 (89%) |
| (95% CI for ORR) | (83-96) | (83-94) |
| CRa | 49 (60%) | 76 (62%) |
| (95% CI for CR rate) | (49-71) | (53-70) |
| PR | 25 (31%) | 34 (28%) |
| (95% CI for PR rate) | (21-42) | (20-36) |
| Stable or progressive disease | 4 (5%) | 7 (6%) |
| Not evaluableb | 3 (4%) | 6 (5%) |
| DOR c | ||
| Estimated median DOR (95% CI), months | NE (20.8-NE) | — |
| Rate of DOR [95% CI], % | ||
| At 6 months | 88 (77-93) | — |
| At 12 months | 76 (64-85) | — |
| At 18 months | 74 (62-83) | — |
| Rate of DOR if CR achieved (95% CI), % | ||
| At 6 months | 98 (94-100) | — |
| At 12 months | 86 (76-97) | — |
| At 18 months | 83 (72-96) | — |
CR required documentation of a negative bone marrow biopsy after treatment, in patients who did not have a negative bone marrow biopsy between their most recent disease progression prior to ZUMA-5 and initiation of lymphodepleting chemotherapy.
Includes indeterminate cases.
Kaplan-Meier estimates, after 14.5 month median follow-up (by reverse Kaplan-Meier method) for all responders in the primary efficacy population. DOR is measured from the date of first objective response to the date of progression or death from any cause.
Includes 3 patients who did not receive axicabtagene ciloleucel.
Abbreviations: CR, complete remission; DOR, duration of response; FL, follicular lymphoma; IRC, independent review committee; NE, not estimable; ORR, objective response rate; PR, partial remission.