A good summary of Bex's overall results:
[387] IODINE I 131 TOSITUMOMAB FOR PATIENTS WITH FOLLICULAR NON-HODGKIN?S LYMPHOMA (NHL): OVERALL CLINICAL TRIAL EXPERIENCE BY HISTOLOGY. J. M. Vose, A. D. Zelenetz, A. Rohatiner, S. Knox, R. Stagg, S. Kroll, G. Tidmarsh, M. S. Kaminski. University of Nebraska, Omaha, NE; Memorial Sloan-Kettering, New York, NY; St. Bartholomew's Hosp., London, United Kingdom; Stanford University, Palo Alto, CA; Coulter Pharmaceutical, Inc., South San Francisco, CA; University of Michigan, Ann Arbor, MI.
Bexxar? (tositumomab and iodine I 131 tositumomab) is a new radioimmunotherapy in development for the treatment of pts with low-grade or transformed low-grade NHL. The data from 5 Phase I-III studies which enrolled pts with low-grade NHL or transformed low-grade NHL were analyzed. This analysis focuses on 185 patients with follicular small cleaved cell (FSCL) or follicular mixed cell with >50% small cleaved cell (FML) histology at the time of treatment with Bexxar. Pts had received a median of 2 (range: 0 ? 13) prior chemotherapy regimens, and 64 of 130 (49%) had failed to respond to their last chemotherapy regimen. The median duration of response to the last chemotherapy regimen was 6 mo. Baseline pt characteristics were: median age 52 yr; 109 pts were male; median time from diagnosis to entry was 29 mo; 38% pts had elevated LDH; 58% pts had a positive baseline bone marrow biopsy (< 25% lymphoma). Pts generally received a single dosimetric dose (450 mg of tositumomab IV followed by 35 mg of tositumomab radiolabeled with 5 mCi of Iodine-131 ) and then had 3 whole body counts obtained over the next 7 days. The whole body counts were used to calculate the required activity (mCi) to deliver the desired therapeutic dose (65 cGy for platelets 100,000-149,999 cells/mm3 and 75 cGy for platelets 150,000 cells/mm3). A single therapeutic dose (450 mg of tositumomab antibody IV followed by 35 mg of tositumomab containing an appropriate activity (mCi) of Iodine-131 to deliver the specified total body dose (cGy) was administered 7-14 days after the dosimetric dose. An overall response (complete and partial) was observed in 149 (81%) pts and 70 (38%) pts had a CR. The median duration of response was 11 mo (95% confidence interval (CI) 8 ? 16 mo), and median TTP for responders was 13 mo (95% CI: 11 ? 19 mo). The median duration of CR was 57 mo (95% CI:31 mo ? not reached). Overall response by histology was: FSCL 94 of 114 (82%) pts and 37% CR, and FML 55 of 69 (80%) pts and 41% CR. The principal toxicity was hematologic; ANC < 500 cells/mm3 = 17%, platelets < 10,000 cells/mm3 = 3%. The hematologic nadir typically occurred at week 5 ? 6 with recovery by week 8?9. Transient, mild to moderate nonhematologic toxicity occurred with the most frequent events being fatigue (38%), fever (37%), and nausea (36%). Eleven percent of previously treated pts developed human anti-murine antibodies. Median survival from study entry was 74 mo (95% CI: 36 mo ? not reached). Conclusion: These results demonstrate that Bexxar is a safe and effective therapy for the treatment of pts with follicular NHL.
Poster Session: Indolent Lymphoid Malignancies and Additional Therapeutic Approaches (9:45 AM-7:30 PM)
Presentation Date: Saturday, December 4, 1999, Time: 9:45AM, Room: Hall B, Poster Board Number: 387
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