Real-world outcomes of glofitamab therapy in CAR-T–naïve patients with relapsed/refractory large B-cell lymphoma

Glofitamab, demonstrated efficacy in patients with refractory diffuse large B-cell lymphoma. However, real-world data on glofitamab in other large B-cell lymphoma (LBCL) subtypes remain limited. This retrospective, multicenter study included 136 CAR-T naïve patients with relapsed and refractory LBCL who were treated with glofitamab within the Compassionate Use Program or routine clinical practice across 22 Russian centers. The median number of therapy lines before glofitamab was 3 (range, 3-9). The median follow-up was 9 months (range, 1-59). The overall response rate was 56% (complete response (CR) - 42%). Median progression-free survival (PFS) was 4.6 months (95% CI: 3.5-9.2), median overall survival (OS) was 14.3 months (95% CI: 10.9-NA). One-year duration of CR was 75.7% (95% CI: 64.9-88.3). Prognostic factors for treatment outcomes included primary refractory or early relapsed disease, ECOG PS >1, B symptoms, and bulky disease ≥7.5 cm; in multivariate analysis, only primary refractory/early relapsed disease independently predicted a lower probability of CR, while ECOG PS >1 and bulky disease ≥7.5 cm were independently associated with shorter PFS. Any AEs were observed in 118 patients (87%), including grade ≥3 in 55 (40%). Cytokine release syndrome occurred in 57 patients (42%, grade ≥3: 2%), infectious complications observed in 62 patients (46%, grade ≥3: 11%). In a real-world scenario glofitamab demonstrates high efficacy and safety in CAR-T naive r/r LBCL patients with CR rate and duration comparable to the pivotal trial.