Lunsumio (mosunetuzumab-axgb)

This review examines CD20 × CD3 bispecific antibodies (BsAbs) like mosunetuzumab, epcoritamab, odronextamab, and glofitamab, which link malignant B-cells and T-cells, thus inducing targeted tumor lysis...This review details their mechanisms, grading, and management, including the use of tocilizumab and corticosteroids...Expert recommendations for antimicrobial prophylaxis, including herpes and varicella zoster virus, pneumocystis, and immunoglobulin supplements are crucial for mitigating these risks. While BsAbs offer an "off-the-shelf" advantage, balancing their efficacy with comprehensive toxicity management is crucial for maximizing patient outcomes.

P1/2, N=5, Not yet recruiting, F. Hoffmann-La Roche AG

P1/2, N=99, Recruiting, BeOne Medicines AG

P1, N=22, Recruiting, F. Hoffmann-La Roche AG

Given the favorable toxicity profile of mosunetuzumab, and rapid and durable complete responses observed in this cohort, further investigation of mosunetuzumab for the treatment of RT, as monotherapy and in combination with other novel agents or chemotherapy, is warranted. NCT02500407.

P3, N=478, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jan 2026 --> May 2026

P2, N=396, Recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Dec 2025 --> Jun 2030

This review focused on 4 CD20 × CD3 BsAbs, as well as surovatamig, a CD19 × CD3 BsAb currently under investigation that has demonstrated promising efficacy against relapsed/refractory B-cell lymphomas. All 4 CD20 × CD3 BsAbs are approved as third-line and beyond therapies: mosunetuzumab for follicular lymphoma (FL), glofitamab for diffuse large B-cell lymphoma (DLBCL), and epcoritamab and odronextamab for both FL and DLBCL (the latter in European Union only)...Multiple studies are currently evaluating these agents in both the relapsed/refractory and frontline settings, either as monotherapy or in combination with other agents. This review summarizes the efficacy and safety of each agent across B-cell lymphoma subtypes, along with their dosing schedules and CRS mitigation strategies.

P1, N=30, Suspended, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jun 2027 | Recruiting --> Suspended | Trial primary completion date: Jun 2026 --> Jun 2027

P2, N=52, Recruiting, Brown University | Trial primary completion date: Aug 2025 --> Aug 2027

BsAbs targeting CD20/CD3, such as epcoritamab, glofitamab, mosunetuzumab, and odronextamab, are rapidly progressing toward widespread clinical application. Although monotherapy remains the standard approach, clinical trials are exploring earlier-line use and combination strategies to further enhance outcomes. Particular attention is given to predictive biomarkers of response and mechanisms of resistance, including target antigen loss, tumor histology, prior therapies, intratumoral and peripheral T-cell status, and the emerging role of minimal residual disease monitoring.