(anti- CD22 antibody) + Rituximab in Previously Untreated Follicular
M.D.. Professor of Medicine. Georgetown University Hospital. Lombardi Comprehensive Cancer Center ... does not appear to predict immunotherapy response ...
A Phase II Trial of Extended Induction Epratuzumab (antiCD22 antibody) + Rituximab in Previously Untreated Follicular Non-Hodgkin’s Lymphoma: CALGB 50701 Bruce D. Cheson. M.D. Professor of Medicine Georgetown University Hospital Lombardi Comprehensive Cancer Center Chair, CALGB Lymphoma Committee
CALGB 50701: Background • Limited prospective information on PET in follicular lymphoma • No data on PET with biological therapy • Goal to determine if PET can be used as a surrogate predictor of response for new drug development
50701 Background • Treatments have improved survival for patients with follicular lymphoma, however chemotherapy and radiation have severe associated toxicities • Extended induction rituximab schedule used by SAKK effective, used as basis for Phase II combinations • CD22 is a 135 kDa sialoglycoprotein expressed only on B-cells, and on >90% of follicular lymphomas
50701 Background • Epratuzumab, a humanized antibody directed at CD22, has single agent efficacy against follicular lymphoma • Rituximab + epratuzumab combination more effective than either antibody alone in mouse model • Rituximab + epratuzumab in weekly x 4 schedule for relapsed/refractory lymphoma demonstrate activity against follicular, with 67% RR and 60% CR/CRu and TTP 18 mos • Toxicities of combination not different from rituximab alone
CALGB 50701: Primary Objectives • Determine response rate (OR and CR) • Determine time to progression (TTP)
50701 Rituximab + Epratuzumab Secondary Objectives • Define toxicity profile • Determine whether combination promising enough to warrant phase III comparison with rituximab alone • Determine correlation between early (day 22-24) change in FDG uptake to RR and TTP • Correlate Fc receptor profiling with response rate • Correlate CD22 expression, lymphoma associated macrophages (LAM) and FOXP3 tissue profiling with RR and TTP
50701 Eligibility Criteria • Previously untreated, histologically confirmed follicular lymphoma, stage III, IV or bulky stage II (>7cm mass) • CD20+ • PS 0-2 • Measurable disease • Low-intermediate risk FLIPI • Accrual goal 58 patients
60 patients registered to the study 54 with adequate response data 49 with PET data/43 with response data Responses – Best usually by week 10 – Some at week 24 – Early PRs improved to CRs
Correlation Between ∆ SUV and Response • Percent response computed by summing SUVs of all lesions for each patient • Assessment done pre- and post-tx • Percent changed using sums of SUVs • Compared IHP with liver-based PET
Very Preliminary Conclusions • % change in SUV did not correlate with response (? Liver-based) • Too early for PFS correlations • While early PET may predict chemotherapy/immunochemotherapy, it does not appear to predict immunotherapy response
Thanks to • • • • • • •
Barbara Grant Jeff Johnson Eric Hsi Sin-Ho Jung Lale Kostakoglu CALGB Investigators Patients on study
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