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MITHIC-FL1: Mosunetuzumab monotherapy in newly diagnosed follicular lymphoma
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Chemoimmunotherapy remains the standard 1L therapy for FL but is associated with limitations, including early progression and complications such as infections and secondary cancers.1 The MITHIC-FL1 trial aims to explore a chemotherapy-free treatment option, challenging traditional 1L chemoimmunotherapy.1 MITHIC-FL1 is a phase II trial evaluating the efficacy and safety of fixed-duration SC mosunetuzumab, a CD20xCD3 bispecific antibody, monotherapy in patients with ND FL (dosed, n = 78; response evaluable, n = 76).1 Primary analysis results from this trial were presented at the 66th ASH Annual Meeting and Exposition by Falchi.1 The primary endpoint was CR rate per Lugano response criteria.1 |
| Key learnings |
| With a median follow-up of 13.3 months and a median treatment duration of 4.8 months, 86% of patients experienced a reduction in tumor burden of ≥80% from baseline. |
| The ORR was 96%, with a CR rate of 80%. The 1-year PFS and OS rates were 91% and 98.7%, respectively. CR was maintained at 1 year in 90% of patients who achieved a CR. |
| Most TEAEs and CRS events were mild and manageable. Low grade injection site reactions (70%), infections (56%), and CRS events (54%) were the most common TEAEs, with the majority being Grade I events. |
| Overall, efficacy and safety data from the MITHIC-FL1 study suggest that mosunetuzumab monotherapy could be a viable treatment option for patients with ND FL and warrant further investigation of SC mosunetuzumab in comparative 1L FL trials. |
Abbreviations: 1L, first-line; ASH, American Society of Hematology; CRS, cytokine release syndrome; CR, complete response; FL, follicular lymphoma; ND, newly diagnosed; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; SC, subcutaneous; TEAE, treatment-emergent adverse event.
- Falchi L. Single-agent mosunetuzumab produces high complete response rates in patients with newly diagnosed follicular lymphoma: Primary analysis of the MITHIC-FL1 trial. Oral abstract #340. American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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