Open-label, phase 2 study of blinatumomab after frontline R-chemotherapy in adults with newly diagnosed, high-risk DLBCL

Abstract

This open-label, multicenter, single-arm, phase 2 study assessed the safety and efficacy of blinatumomab consolidation therapy in adult patients with newly diagnosed, high-risk diffuse large B-cell lymphoma (DLBCL; International Prognostic Index 3–5 and/or double-/triple-hit or double MYC/BCL-2 expressors) who achieved complete response (CR), partial response (PR), or stable disease (SD) following run-in with 6 cycles of R-chemotherapy (NCT03023878). Of the 47 patients enrolled, 28 received blinatumomab. Five patients (17.9%) experienced grade 4 treatment-emergent adverse events of interest (neutropenia, n = 4; infection, n = 1). Two deaths reported at the end of the study were unrelated to treatment with blinatumomab (disease progression, n = 1; infection, n = 1). 3/4 patients with PR and 4/4 patients with SD after R-chemotherapy achieved CR following blinatumomab. Consolidation with blinatumomab in patients with newly diagnosed, high-risk DLBCL who did not progress under R-chemotherapy was better tolerated than in previous studies where blinatumomab was used for treatment of patients with lymphoma.

Keywords:

• Relapsed/refractory
• high-risk DLBCL
• blinatumomab

Acknowledgments

The authors thank all the site investigators and patients who participated in this study. Swapnil Kher, PhD, of Cactus Life Sciences (part of Cactus Communications) and Ben Scott, PhD (Scott Medical Communications, LLC) provided medical writing assistance funded by Amgen Inc. Graphics support was provided by Robert Dawson of Cactus Communications and funded by Amgen Inc. This study was funded by Amgen Inc and Astellas Pharma Inc. The funders contributed to study design, data collection, data analysis, and data interpretation, and funded a professional medical writer to assist with writing the report.

Authorship contributions

All authors contributed in writing/review of the manuscript and provided approval for publication. D.A.K. contributed to the study design, data collection, data analysis, and data interpretation. J.D.M., A.A. Anderson, A.A. Avilion, H.L.W., Y.C., T.D., W.K., and Y.K., contributed to the study design, data analysis, and data interpretation. M.P.C., K.A.D., C.T., N.J.M., S.S.K., A.V., A.M.G.-S., G.R.-G., M.B.-O., S.T.L., and E.G.-B. contributed to the data collection, analysis, and interpretation.

Disclosure of interest

D.A.K. received honoraria from and fees for consulting or advisory role and speakers’ bureau from AbbVie and Stemline. M.P.C. received fees for consulting from Teva Pharmaceuticals. C.T. received fees for consulting or advisory role from Amgen, Celgene, Jazz Pharmaceuticals, Kite/Gilead, Novartis, Servier, and Roche and received research funding from Roche, Celgene, and Hospira. N.J.M. received fees and honoraria from Kite/Gilead, Janssen, and Amgen Inc. A.V. received honoraria from and fees for consulting or advisory role and speakers’ bureau from Amgen, Roche, Kite/Gilead, and Novartis. A.M.G.-S. received honoraria from and fees for consulting or advisory role and speakers’ bureau from Celgene, Servier, Gilead, EUSA Pharma, MorphoSys, Kyowa Kirin, iQone, and Roche; research grant from Celgene and Janssen; and non-financial support/travel fees from Celgene, Janssen, Servier, Roche, and Celltrion. G.R.-G. received consultancy fees and/or honoraria from Janssen, Takeda, Celgene, and Roche. M.B.-O. received research funding from Roche; received honoraria from and fees for consulting or advisory role and speakers’ bureau from Roche, Gilead/Kite, Takeda, and Celgene. E.G.-B. received honoraria from and fees for consulting or advisory role and speakers’ bureau from Janssen, Gilead, Celgene, Kyowa Kirin, Celltrion, AbbVie, Takeda, and Roche. A.A. Avilion is a stockholder of Amgen. J.D.M., W.K., Y.C., H.L.W., A.A. Anderson, Y.K., and T.D. are Amgen employees and report stock ownership. K.A.D., S.S.K., and S.T.L. have nothing to disclose.

Data availability statement

Qualified researchers may request data from Amgen clinical studies. Deidentified individual participant data are available indefinitely at http://www.amgen.com/datasharing