Epkinly (epcoritamab-bysp)

P2, N=26, Recruiting, University of Miami | Not yet recruiting --> Recruiting

P2, N=18, Recruiting, University of Washington | Not yet recruiting --> Recruiting

P1/2, N=30, Not yet recruiting, M.D. Anderson Cancer Center

IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.

P2, N=33, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Aug 2028 --> Jun 2029 | Trial primary completion date: Aug 2028 --> Jun 2029

BsAbs such as epcoritamab, glofitamab, and mosunetuzumab have demonstrated substantial efficacy across both aggressive and indolent B-cell non-Hodgkin lymphomas (B-NHL), with largely manageable safety profiles...Approaches incorporating BsAbs into cytotoxic backbones and antibody-drug conjugates, as well as chemotherapy-free regimens such as BsAbs combined with lenalidomide, are discussed...BsAbs represent a major advance in B-NHL, offering high rates of deep remission with predictable safety and outpatient feasibility. As trial data continues to mature, BsAb-based regimens are poised to become foundational across multiple lines of therapy, reshaping expectations for patients with both aggressive and indolent lymphomas.

In patients with Richter transformation, epcoritamab monotherapy showed clinically meaningful antitumour activity, although the investigator-assessed overall response rate was below the alternative hypothesis of 50%, with a safety profile consistent with previous studies. These findings support further investigation of epcoritamab as a potential treatment option for patients with Richter transformation.

P2, N=29, Suspended, City of Hope Medical Center | Recruiting --> Suspended

The clinical course was aggressive, and the patient died of the disease on the 13th day of hospitalization. This case highlights the potential for aggressive T-cell lymphoma to emerge during bispecific antibody therapy, a phenomenon that has also been noted in the context of CAR-T cell therapy.

P3, N=72, Active, not recruiting, Genmab

P2, N=33, Not yet recruiting, City of Hope Medical Center

Currently, approximately sixty percent of patients are cured with R-CHOP as frontline treatment, while the remaining patients experience primary refractory or relapsed (R/R) disease. Recently, the introduction of Pola-R-CHP as front-line therapy has represented a major advance in the management of DLBCL, resulting in improved outcomes...The most extensively studied BsAbs, in both the frontline and relapsed/refractory (R/R) settings, include epcoritamab, glofitamab, mosunetuzumab, and odronextamab...EMA has also approved glofitamab in combination with gemcitabine and oxaliplatin (GemOx) for patients with R/R DLBCL ineligible for ASCT, whereas this indication has not been approved by FDA...BsAbs represent a breakthrough therapy in the treatment of DLBCL, especially in R/R diseases. The purpose of this article is to review the landscape of BsAbs in DLBCL.