Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B‐cell lymphoma

Author:

Izutsu Koji1ORCID,Kumode Takahiro2,Yuda Junichiro3,Nagai Hirokazu4,Mishima Yuko5ORCID,Suehiro Youko6,Yamamoto Kazuhito7,Fujisaki Tomoaki8,Ishitsuka Kenji9ORCID,Ishizawa Kenichi10,Ikezoe Takayuki11,Nishikori Momoko12ORCID,Akahane Daigo13,Fujita Jiro14,Dinh Minh15,Soong David16,Noguchi Hidehisa17,Buchbjerg Jeppe Klint18,Favaro Elena19,Fukuhara Noriko20

Affiliation:

1. Department of Hematology National Cancer Center Hospital Tokyo Japan

2. Department of Hematology and Rheumatology Kindai University Osaka Japan

3. Departments of Hematology and Experimental Therapeutics, Office for the Promotion of Hematological Treatment Development National Cancer Center Hospital East Kashiwa Japan

4. Department of Hematology National Hospital Organization Nagoya Medical Center Nagoya Japan

5. Department of Hematology Oncology, Japanese Foundation for Cancer Research Cancer Institute Hospital Tokyo Japan

6. Department of Hematology and Cell Therapy National Hospital Organization Kyushu Cancer Center Fukuoka Japan

7. Department of Hematology and Cell Therapy Aichi Cancer Center Nagoya Japan

8. Department of Hematology Japan Red Cross Society, Matsuyama Red Cross Hospital Matsuyama Japan

9. Department of Hematology and Rheumatology Kagoshima University Kagoshima Japan

10. Third Department of Internal Medicine Yamagata University Yamagata Japan

11. Department of Hematology Fukushima Medical University Hospital Fukushima Japan

12. Department of Hematology and Oncology, Graduate School of Medicine Kyoto University Kyoto Japan

13. Department of Hematology Tokyo Medical University Tokyo Japan

14. Department of Hematology and Oncology, Graduate School of Medicine Osaka University Osaka Japan

15. Oncology Clinical Development AbbVie North Chicago Illinois USA

16. Translational Data Science Genmab Plainsboro New Jersey USA

17. Biostatistics Genmab Tokyo Japan

18. Clinical Research Scientists Genmab Copenhagen Denmark

19. Medical Hematology Genmab Copenhagen Denmark

20. Department of Hematology Tohoku University Sendai Japan

Abstract

AbstractEpcoritamab is a subcutaneously administered CD3xCD20 bispecific Ab that showed deep, durable responses with a manageable safety profile in patients with relapsed or refractory (R/R) diffuse large B‐cell lymphoma (DLBCL) in the global multicenter pivotal phase II trial EPCORE NHL‐1. Here, we present results from the similar EPCORE NHL‐3 phase I/II trial evaluating epcoritamab monotherapy in Japanese patients with R/R CD20+ B‐cell non‐Hodgkin's lymphoma previously treated with two or more lines of therapy. Epcoritamab was dosed subcutaneously in 28‐day cycles; once weekly during cycles 1–3, every 2 weeks during cycles 4–9, and every 4 weeks from cycle 10 until disease progression or unacceptable toxicity. Step‐up dosing and cytokine release syndrome (CRS) prophylaxis were used during treatment cycle 1. As of January 31, 2022, 36 patients received treatment with 48 mg epcoritamab monotherapy. At a median follow‐up of 8.4 months, overall response and complete response rates by independent review committee were 55.6% and 44.4%, respectively. The median duration of response, duration of complete response, and overall survival were not reached at the time of data cut‐off. The most common treatment‐emergent adverse events of any grade were CRS (83.3%), injection‐site reactions (69.4%), infections (44.4%), neutropenia (38.9%), hypokalemia (27.8%), and decreased lymphocyte count (25.0%). Cytokine release syndrome occurrence was predictable; events were primarily low grade (grade 1–2), all resolved, and none led to treatment discontinuation. These encouraging results are consistent with previous findings and support the ongoing clinical evaluation of epcoritamab for the treatment of R/R DLBCL, including in earlier treatment lines.

Publisher

Wiley

Subject

Cancer Research,Oncology,General Medicine

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