Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma.
Koji IzutsuTakahiro KumodeJunichiro YudaHirokazu NagaiYuko MishimaYouko SuehiroKazuhito YamamotoTomoaki FujisakiKenji IshitsukaKenichi IshizawaTakayuki IkezoeMomoko NishikoriDaigo AkahaneJiro FujitaMinh DinhDavid SoongHidehisa NoguchiJeppe Klint BuchbjergElena FavaroNoriko FukuharaPublished in: Cancer science (2023)
Epcoritamab 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.
Keyphrases
- diffuse large b cell lymphoma
- low grade
- epstein barr virus
- combination therapy
- acute myeloid leukemia
- acute lymphoblastic leukemia
- end stage renal disease
- open label
- chronic kidney disease
- oxidative stress
- machine learning
- study protocol
- stem cells
- newly diagnosed
- cross sectional
- patient reported outcomes
- artificial intelligence
- electronic health record
- chemotherapy induced