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Original Articles

Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma

, , , , , , , , & show all
Pages 2103-2112 | Received 30 Aug 2019, Accepted 16 Apr 2020, Published online: 16 Jun 2020
 

Abstract

The phase 2 portion of this open-label phase 2/3 study assessed the efficacy and safety of blinatumomab as second salvage for aggressive relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (B-NHL) following platinum-based first salvage chemotherapy. Forty-one patients with aggressive disease (32% relapsed; 68% refractory) enrolled and received stepwise blinatumomab (9–28–112 μg/day) in a 70-day cycle 1 and an optional 28-day cycle 2; 19 (46%) completed cycle 1 and 3 (7%) completed cycle 2. The overall response rate after 12 weeks was 37%, including 9 (22%) complete metabolic responses. Eight (20%) patients (all responders) subsequently received stem cell transplants. Grade ≥3 adverse events were reported in 29 (71%) patients. Grade 3 cytokine release syndrome occurred in one patient. Grade 3 neurologic events occurred in 10 (24%) patients; all resolved. Blinatumomab monotherapy appears effective as second salvage therapy in patients with r/r aggressive B-NHL.

Trial registration: NCT02910063.

Acknowledgements

The authors acknowledge Ben Scott (Scott Medical Communications, LLC), PhD, for medical writing assistance funded by Amgen Inc.

Disclosure statement

LC reports travel support from Amgen Inc. NJM reports fees and honoraria from AbbVie, Janssen, and Amgen Inc.; advisory board and travel support from Amgen Inc and Roche. AR reports consulting, advisory board, travel support, and research grant from Amgen Inc.; advisory board and speaker fees from Pfizer; advisory board and travel support from Celgene, Gilead, and Roche; research grant from Roche. CF reports travel support from Amgen Inc. AZ, SJ, DC, JLF report employment by and stock ownership in Amgen Inc. KDM and GV report no disclosures.

Additional information

Funding

This study was supported by Amgen Inc.