H. Lee Moffitt Cancer Canter and Research Institute, Tampa, FL
Frederick Lundry Locke , Sattva Swarup Neelapu , Nancy L. Bartlett , Lazaros J. Lekakis , David Bernard Miklos , Caron Alyce Jacobson , Ira Braunschweig , Olalekan O. Oluwole , Tanya Siddiqi , Yi Lin , John Timmerman , Patrick Michael Reagan , Adrian Bot , John Rossi , Lynn Navale , Yizhou Jiang , Jeff Aycock , Meg Elias , Jeffrey S. Wiezorek , William Y. Go
Background: Outcomes in activated B cell subtype diffuse large B cell lymphoma (ABC-DLBCL) and r-NHL are poor (Sehn Blood 2015, Crump ASCO 2016). ZUMA-1 is the first, multicenter trial of anti-CD19 chimeric antigen receptor (CAR) T cells, axi-cel, in r-NHL. Methods: Dosing and eligibility were per Neelapu ASH 2016. The primary endpoint was objective response rate (ORR); secondary endpoints were duration of response (DOR), overall survival (OS), and safety. Cell of origin (COO) and CD19 status were assessed centrally using Lymphoma Subtyping Test NanoString (Wallden JCO 2015) and a validated immunohistochemistry assay, respectively. Results: As of Jan 27, 2017, 111 patients (pts) were enrolled; the manufacturing success rate was 99% with an average 17-d turnaround time; 101 pts (modified intent-to-treat [mITT] population) received axi-cel. In the mITT population, the ORR was 82% (complete response [CR], 54%). With 8.7 m median follow-up, 44% remain in response and 39% in CR. The median DOR was 8.1 m and not reached (NR) for pts with CR. Median OS was NR. Results for clinical and biologic covariates are listed in the table. In pts who received tocilizumab (n = 43) and/or steroids (n = 27) for cytokine release syndrome (CRS) and/or neurologic events (NE), ORR was 84% and 78%, respectively. Most common grade ≥3 adverse events (AEs) were neutropenia (66%), leukopenia (44%), anemia (43%), febrile neutropenia (31%), thrombocytopenia (24%), and encephalopathy (21%). Rates of grade ≥3 CRS and NE were 13% and 28%, respectively. There were 3 grade 5 AEs (Neelapu ASH 2016). Conclusions: Axi-cel induced an ORR of 82% in pts with r-NHL, response is ongoing in 44% of pts at 8.7 m. Similar clinical responses were observed in pts with r-ABC-DLBCL. AEs were manageable and the use of tocilizumab/steroids did not appear to impact ORR. Drs Locke and Neelapu contributed equally. Funding source: Kite Pharma and Leukemia & Lymphoma Society Therapy Acceleration Program Clinical trial information: NCT02348216
Group (n = samples evaluable) | % Positive for Marker in Evaluable Samples | ORR/CR |
---|---|---|
mITT (n = 101) | N/A | 82%/54% |
GCB (n = 69) | 71% | 88%/57% |
ABC (n = 69) | 25% | 76%/59% |
CD19+ (n = 82) | 90% | 85%/57% |
CD19- (n = 82) | 10% | 75%/50% |
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Abstract Disclosures
2022 ASCO Annual Meeting
First Author: Paolo Strati
2021 ASCO Annual Meeting
First Author: Hongbo Yang
2019 ASCO Annual Meeting
First Author: Sattva Swarup Neelapu
2020 ASCO Virtual Scientific Program
First Author: Frederick Lundry Locke