LUMOXITI DEMONSTRATED DURABLE EFFICACY IN HEAVILY PRETREATED PATIENTS
The primary endpoint for Study 1053 was BICR-assessed rate of durable CR1,*
- Durable CR, an endpoint agreed upon with the FDA, is the proportion of patients who, following BICR-assessed CR,† maintained hematologic remission‡ for more than 180 days1
LUMOXITI demonstrated durable responses among patients with relapsed/refractory hairy cell leukemia (HCL) who failed at least 2 prior therapies (N=80)1
At patients’ respective 181-day evaluation
The patients who achieved durable CR at the 181-day follow-up evaluation represent 88% of patients who achieved an initial CR (29/33)1
At patients’ respective 360-day evaluation
*Confirmed by maintenance of hematologic remission more than 180 days after BICR-assessed CR.
Secondary response endpoints included ORR,§ CR, and PR1,¶
80% of patients (64/80) had normalization of hematologic parameters and achieved hematologic remission1
- Median time to hematologic remission was 1.1 months (range: 0.2 to 13)1
Landmark Rates of DOCR†† (n=33)16
DOCR=duration of complete response; DOR=duration of response; NR=not reached; PFS=progression-free survival.
||ORR defined as best overall response of CR or PR.
¶Both primary and final analyses were performed by BICR. Values are reported as median number of months (range).
#PR defined as ≥50% decrease or normalization (<500/mm3) in peripheral blood lymphocyte count, reduction of pre-existing
lymphadenopathy and/or organomegaly, and hematologic remission.
**This estimate by the Kaplan-Meier approach was driven by the event time of the last patient in the at-risk set.
††Calculated using the Kaplan-Meier method.