Lunsumio (mosunetuzumab-axgb)

P2, N=36, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting

Findings highlight a potential positive benefit-risk profile of liso-cel over mosunetuzumab as a 3L+ treatment for R/R FL.

P1/2, N=80, Recruiting, BeiGene | N=170 --> 80

While lenalidomide-based immunotherapy remains the standard of care for relapsed iNHL, its frontline use is limited, due to nonsuperiority as compared to CIT...We also summarize the activity in iNHL of agents targeting antigens other than CD20 (including CD19 and CD79b), and novel immunotherapies and cellular therapies (including NK-cell based treatments). The therapeutic landscape of iNHL is soon to significantly change.

P1, N=200, Recruiting, ADC Therapeutics S.A. | Trial completion date: Feb 2026 --> Dec 2026 | Trial primary completion date: Feb 2025 --> Dec 2025

P1/2, N=713, Active, not recruiting, Genentech, Inc. | Trial primary completion date: Sep 2025 --> May 2024

P2, N=31, Not yet recruiting, Medical College of Wisconsin | Initiation date: Dec 2024 --> Jun 2025

P3, N=242, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Feb 2025 --> May 2025

In comparison to obinutuzumab, mosunetuzumab led to an equivalent or enhanced cytotoxicity against B cell lymphoma cell lines and primary patient samples, where this effect was even more prominent. In summary, we consider the combination of stimulated γδ T cells and mosunetuzumab to be a promising therapeutic approach for future clinical trials.

P2, N=42, Recruiting, Abramson Cancer Center at Penn Medicine | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Dec 2024 --> Jun 2026

P2, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025

S2308 is a study comparing rituximab, which is not the standard of care, to.mosunetuzumab-axgb, a first-in-class CD20-directed CD3 T-cell engager with.unknown long term side effects, in a heterogeneous patient population in which a fifth.of patients do not need treatment for at least 10 years. Beyond the limitations of.the study design, this study would be the basis of regulatory approval and cooperative.groups receiving federal funding should not be running this trial. Study sites are USbased.and mostly include community oncology practices, risking inclusion of very low.risk patients that are most likely to be harmed by any treatment.

P1, N=137, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2029 --> Feb 2030 | Trial primary completion date: Aug 2027 --> May 2028

P1, N=18, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=50 --> 18 | Trial completion date: Jun 2025 --> Dec 2024

P3, N=478, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P1, N=24, Recruiting, Washington University School of Medicine | N=40 --> 24

P3, N=474, Recruiting, Hoffmann-La Roche | Trial completion date: May 2029 --> Dec 2029

P2, N=22, Recruiting, Lazaros Lekakis | N=40 --> 22

P1/2, N=237, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2027 --> Oct 2030 | Trial primary completion date: Nov 2025 --> Oct 2028

In this study, we further developed our protocol MCCS-Docker for protein-protein interactions and applied it to investigate the structural intricacies of CD3 interactions with therapeutic antibodies such as OKT3, UCHT1, Mosunetuzumab, Odronextumab, Glofitamab, and Epcoritamab using computational modeling techniques. Molecular dynamics simulations validated the stability of these interactions over time, confirming the reliability of the binding poses generated from docking studies. Overall, our study offered a novel method to predict critical residues in protein-protein interactions and enhanced the understanding of the structural determinants governing BsAb interactions with target proteins, offering valuable insights for designing and optimizing immunotherapeutic agents for NHL and related hematologic malignancies.

P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2028 --> Mar 2029 | Trial primary completion date: Jul 2026 --> Mar 2027

P1, N=137, Recruiting, Hoffmann-La Roche | Trial primary completion date: May 2027 --> Aug 2027

P2, N=35, Recruiting, Izidore Lossos, MD | Not yet recruiting --> Recruiting

This is the first study to assess changes in lymphocytes, T cells, and CAR transgene levels in patients treated with BsAb after CAR-T. These findings suggest an interaction between prior CAR-T and BsAb outcomes, and have implications for optimal timing of BsAb after CAR-T.

P2, N=42, Active, not recruiting, University of Washington | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Mar 2025 | Trial primary completion date: Dec 2025 --> Mar 2025

CD3 × CD20 BsAbs have shown the most promise in clinical development for B-NHL patients, with structural variations affecting their target affinity and potency. This review summarizes the current clinical trials of BsAbs for relapsed/refractory FL, highlighting the approval of some agents, their role in first-line treatment or combination therapies, their toxicity profiles, and the future of this therapeutic approach compared to other immune cell therapies.

P1/2, N=8, Terminated, Hoffmann-La Roche | Completed --> Terminated; Study was terminated due to Sponsor decision.

Treatment with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone has become the standard of care for newly diagnosed CD20-positive DLBCL with an International Prognostic Index score of 2 to 5, based on its reported efficacy for this indication. In addition, the development of immunotherapy such as anti-CD19-chimeric antigen receptor (CAR)-T therapy and bispecific antibodies such as epcoritamab, mosunetuzumab, and glofitamab has led to a paradigm shift in treatment of relapsed/refractory DLBCL. This review summarizes the evolution of treatment development for DLBCL, as well as the results of the current clinical standard of care and new therapies that are expected to become the standard of care.

P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026

P1, N=125, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2028 --> Mar 2029 | Trial primary completion date: Jul 2026 --> Mar 2027

P3, N=222, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> Feb 2027 | Trial primary completion date: May 2025 --> Feb 2025

P2, N=345, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting

P2; N=31; Not yet recruiting; Sponsor:Medical College of Wisconsin

P1/2, N=187, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting

P2, N=35, Not yet recruiting, Izidore Lossos, MD

P2, N=36, Not yet recruiting, M.D. Anderson Cancer Center

P2, N=41, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Mar 2028

P2, N=20, Recruiting, University of Washington | Not yet recruiting --> Recruiting

P1/2, N=40, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting

P2, N=56, Not yet recruiting, Fondazione Italiana Linfomi - ETS

P2, N=41, Not yet recruiting, City of Hope Medical Center

Scenarios one and two resulted in ICERs of $105,353 and $102,695, respectively. This study finds that axi-cel is cost-effective compared to mosun at the commonly cited $150,000/QALY US willingness-to-pay threshold, with robust results across a range of sensitivity analyses accounting for parameter uncertainty.