SORRY THIS IS A REPEAT
Data from just published abstracts t be presented at ASH. Bex shows strong results in Rit relapsed patients. Since most Rit patients unfortunately eventually relapse we are talking about a huge market. Hard to compare but the data looks better than Zev which had no CRs in Rit relapsed patients and a less than 50% RR. Now if they could only get the DAMM BLA ACCEPTED.
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[2184] IODINE-131 TOSITUMOMAB FOR NON-HODGKIN’S LYMPHOMA (NHL) PATIENTS WHO PROGRESSED AFTER TREATMENT WITH RITUXIMAB: RESULTS OF A MULTI-CENTER PHASE II STUDY.
S.J. Horning, J.B. Lucas, A. Younes, D. Podoloff, V. Jain, S. Kroll, R. Stagg, K. Nadeau, G. Tidmarsh Stanford University, Stanford, CA, USA; M.D. Anderson Cancer Center, Houston, TX, USA; U.S. Oncology, Dallas, TX, USA; Coulter Pharmaceutical, Inc, South San Francisco, CA, USA
Iodine-131 tositumomab (Bexxar™) is a new radioimmunotherapy active in chemotherapy-relapsed or -refractory indolent (IN) or transformed indolent (TR) NHL. The current study was undertaken to assess overall response rate (ORR), duration of response, time to progression (TTP) and safety of Bexxar in patients (pt) previously treated with the chimeric anti-CD20 antibody, rituximab. Eligible pt had a confirmed diagnosis of IN, TR, or de novo follicular large cell (FLC) NHL and progressed after or failed to respond to rituximab. Thirty-eight patients were studied [Stanford (15), M.D. Anderson (13), U.S. Oncology (10)]. Histologies included small lymphocytic (1), follicular small cleaved or mixed (25), FLC (3), transformed (7). Pt characteristics included median age 57 years, 4 prior chemotherapy regimens (68%), marrow involvement (32%). Pt received a dosimetric dose (5 mCi iodine-131) and whole body counts to calculate a therapeutic dose of 75 cGy (platelets > 150,000/ml) or 65 cGy (platelets 100,000-149,000/ml). All pt completed the therapeutic dose. Toxicity was primarily hematologic and transient. Median absolute neutrophil count nadir was 1200/ml and median platelet nadir was 90,000/ml. The median durations of grade IV neutropenia (6 pt) and thrombocytopenia (4 pt) were 9 and 29 days, respectively. No pt converted to HAMA positivity after the therapeutic dose. Investigator-assessed confirmed responses to Bexxar (at least 2 assessments 4 weeks apart) by prior treatment with rituximab were as follows:Prior Response to Rituximab
No 0-6 mo > 6 mo All Pt
N Pt 24 12 2 38
N Evaluable 21 11 1 33
Bexxar ORR 57% 55% 100% 58%
Bexxar CR 14% 27% 100% 21%
Median duration of response was 478 d. Median TTP for responding and all pt were 566 d and 182 d, respectively. In conclusion, Bexxar is a safe and effective treatment strategy for pt who progress after or fail to respond to rituximab.
Keywords: Hodgkin's disease; Rituximab |
