Epkinly (epcoritamab-bysp)

P2, N=43, Not yet recruiting, AIDS Malignancy Consortium

P1/2, N=460, Recruiting, Bristol-Myers Squibb | N=308 --> 460

T cell-redirecting therapies represent a central pillar in modern oncology, delivering high response rates across hematologic malignancies with expanding roles in earlier treatment settings. Future progress will depend on improving durability, optimizing sequencing, mitigating toxicity, and enhancing real-world deliverability through next-generation and multitarget platforms.

Fixed-duration epcoritamab monotherapy showed promising complete response rates and a manageable safety profile in older adults with newly diagnosed DLBCL and comorbidities, with slight differences between stages 1 and 2. Continued investigation of epcoritamab as a first-line chemotherapy-free treatment option is warranted.

CAR-T products achieved overall response rates (ORR) of 52-83% and complete response (CR) rates of 40-58%; randomized second-line trials favored axicabtagene ciloleucel and lisocabtagene maraleucel over standard care...BsAbs were active in heavily pretreated disease (epcoritamab ORR 50%/CR 44%; glofitamab ORR 55%/CR 35%), with predominantly low-grade cytokine release syndrome. Selinexor showed more modest efficacy (ORR 39%/CR 16%) but durable benefit in complete responders.ConclusionsCurrent evidence supports a stepwise treatment framework: DLBCL-like induction at transformation, autologous stem-cell transplant in fit, chemosensitive responders, CAR-T as the preferred option at first relapse, BsAbs after CAR-T or when cellular therapy is not feasible, and selinexor in later-lines of therapy. Additional prospective t-FL-inclusive trials are needed to refine treatment selection and biomarker-guided sequencing.

P1, N=12, Recruiting, University of Utah | Not yet recruiting --> Recruiting

P1/2, N=38, Recruiting, Yazeed Sawalha | Trial completion date: Dec 2028 --> Oct 2027 | Trial primary completion date: Dec 2026 --> Aug 2027

P2/3, N=116, Active, not recruiting, AbbVie Deutschland GmbH & Co. KG | Recruiting --> Active, not recruiting

P2, N=20, Not yet recruiting, Mwanasha Merrill, MD

Among the agents studied, epcoritamab demonstrated the highest ORR...Cytokine release syndrome was the most common toxicity, predominantly grade 1-2, while neurotoxicity and hematologic adverse events were manageable. In conclusion, CD3×CD20 BsAbs exhibit meaningful efficacy and acceptable safety profiles in R/R LBCL patients following CAR-T failure, particularly in those with longer relapse intervals.

P2, N=29, Active, not recruiting, City of Hope Medical Center | Suspended --> Active, not recruiting

P1/2, N=30, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Jun 2026 --> Feb 2026