Clinical Efficacy Data

BEXXAR achieved complete responses (33%) in patients with Rituximab-refractory and -relapsed disease¹

The efficacy of the BEXXAR therapeutic regimen was evaluated in a multicenter, single-arm study of 40 patients with low-grade, transformed low-grade, or follicular large-cell lymphoma whose disease had not responded to or had progressed after at least 4 doses of Rituximab therapy

- Patient characteristics^2,³:
- 40% had an overall response to their last Rituximab therapy
- 12% had a complete response to their last Rituximab therapy
- Median duration of response to their most recent Rituximab therapy was 4.7 months
Patients in this trial also had chemotherapy-relapsed or -refractory disease³


Response Rate (95%) CI^†	68% (51%, 81%)	33% (19%, 49%)
Median Duration of Response (95%) CI^† (Range)	16 Months (10, NR^‡) (1+ to 38+ months)	NR^‡ (15, NR^‡) (4 to 38+ months)

*Complete response rate = Pathologic and clinical complete responses.
^†CI = Confidence interval.
^‡ NR = Not Reached. Median duration of follow-up = 26 months.

BEXXAR produced durable responses in Rituximab-refractory patients (n=35)¹

35 of the 40 patients (88%) met the definition of Rituximab-refractory: no response or a response of less than 6 months’ duration


Response Rate (95%) CI^†	63% (45%, 79%)	29% (15%, 46%)
Median Duration of Response (Range)	25 Months (4 to 38+ months)	NR^‡ (4 to 38+ months)

*Complete response rate = Pathologic and clinical complete responses.
^†CI = Confidence interval.
^‡ NR = Not Reached. Median duration of follow-up = 26 months.

Chemotherapy-refractory patients responded to BEXXAR¹

BEXXAR was evaluated in a multicenter, single-arm, open-label study of 60 chemotherapy-refractory patients
- 53 patients had no response to prior therapy
- 7 patients had a response of <6 months


Response Rate (95%) CI^†	47% (34%, 60%)	20% (11%, 32%)
Median Duration of Response (95%) CI^† (Range)	12 Months (7,47) (2 to 47 months)	47 months (47, NR^‡) (9 to 47 months)

*Complete response rate = Pathologic and clinical complete responses.
^†CI = Confidence interval.
^‡ NR = Not Reached. Median duration of follow-up = 26 months.

BEXXAR produced durable responses¹

28 of 60 chemotherapy-refractory patients (47%) responded to BEXXAR
12 of 60 patients (20%) had a complete response
Median duration of response was 47 months among patients who had a complete response with BEXXAR
- 8 patients with complete response were followed after the last
independent review panel; duration of ongoing response ranged from
42 to 85 months
Determination of the clinical benefit of the BEXXAR therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival

Durable responses with BEXXAR were also achieved in 3 supportive studies including 130 patients¹

Durable objective responses (response duration ≥1 year) were demonstrated in 3 single-arm studies that included 130 patients evaluable for efficacy with Rituximab-naive follicular non-Hodgkin’s lymphoma, with or without transformation, who had relapsed or were refractory to chemotherapy

Median duration of overall response ranged from 13 to 16 months

Due to small sample sizes in the supportive studies, as in the 2 studies described above, the 95% confidence intervals for the median durations of response are wide

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Complete Prescribing Information for
BEXXAR (Tositumomab and Iodine I 131 Tositumomab)

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