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

CI=confidence interval.

*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.