Abstract
7095 Background: Modern multi-agent chemotherapy (CT) regimens result in complete remission (CR) rates of 80-90% and long-term survival rates of 40% in pts with ALL. The most common reason for treatment failure is relapse of the disease. Post-relapse therapies lead to second CR in 30-40% of pts with a 5-year survival of <10%. CD22 expression occurs in >90% of pts with ALL. Inotuzumab ozogamicin (IO) is a CD22 monoclonal antibody bound to a toxin, calecheamicin. We reported overall response rate of 57% with single-agent IO in R/R ALL (Kantarjian, Lancet Oncology 2012). Methods: We analyzed the outcomes of patients with R/R ALL treated with single-agent IO (n=90) vs. historical controls (n=292) treated with combination CT at our institution from 1990-2008. IO was dosed at 1.8 mg/m2 every 3-4 weeks (first 41 pts), and later weekly dosing (0.8 mg/m2 day 1, 0.5 mg/m2 on days 8 and 15, every 3-4 weeks). Fifty-percent of historical controls were treated with hyper-CVAD CT (n=147). Results: The median age in the IO cohort was 39.5 years (yrs) (range 4-84) and in the CT cohort was 37 yrs (range 14-81). Overall CR/CRp rate was 49% with IO vs. 29% with CT. In salvage 1, CR/CRp rate was significantly better with IO [66% vs. 40% with CT (p=0.007)]. When only hyper-CVAD-based regimens were included, the CR/CRp was not statistically different (66% with IO vs. 56% with hyper-CVAD, p=0.332). In salvage 1, the median overall survival (OS) was 9.2 months (mos) with IO vs. 6.2 mos with CT (p=0.06 compared with IO) vs. 7.9 mos with hyper-CVAD (p=0.48 compared with IO). In salvage 2, CR/CRp rate was better with IO vs. CT (44% vs. 16%, p=<0.001); OS was not different (4.3 mos vs. 2.5 mos, p=0.74). In salvage 3, CR/CRp rate was better with IO vs. CT (46% vs. 19%, p=0.03); OS was also better with IO vs. CT (6.6 mos vs. 2.6 mos, p=0.01). In salvage 4, CR/CRp rate was better with IO vs. CT (27% vs. 9%, p=0.01); OS was not statistically different (7.4 mos vs. 1.9 mos, p=0.09). Conclusions: In pts with R/R ALL, outcomes after single-agent IO are better than pts treated with CT alone. In addition, IO has fewer side effects than CT. IO has the potential to replace multi-agent CT as standard of care for treatment of pts with R/R ALL.
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