Efficacy and Safety of Glofitamab Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A United Russian Experience Based on the Compassionate Use Program

BACKGROUND. Clinical trials of glofitamab (Glofit) have demonstrated its high efficacy and tolerable toxicity profile in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients. However, the data on its use in a real-world setting remain sparse. AIM. To assess the efficacy and safety of Glofit in the combined cohort of R/R DLBCL patients in a real-world setting in the Russian Federation. MATERIALS & METHODS. This retrospective multi-center study enrolled 88 R/R DLBCL patients treated with Glofit under a compassionate use program from 2021 to 2024 in 22 Russian medical institutions. The median age of patients was 54 years (range 21–83 years), there were 42 (48 %) male patients. The main eligibility criteria were ≥ 3 prior therapy lines and exhaustion of available standard treatment methods. Glofit was administered as a monoregimen according to the schedule recommended in the package insert. RESULTS. With the follow-up median of 8.4 months (range 0.6–52 months), overall response was achieved in 46 (53 %) patients including 36 (42 %) patients with complete response (CR). The median overall survival (OS) was 13.1 months (95% confidence interval [95% CI] from 8.6 months to not reached), the 1-year OS was 55.7 % (95% CI 45.6–68.1 %). The median progression-free survival (PFS) was 4.2 months (95% CI 2.8–8.8 months), and the 1-year PFS was 33.5 % (95% CI 24.6–45.8 %). The median OS and PFS in patients with CR was not reached, whereas the 1-year PFS and OS were 73.7 % (95% CI 59.4–91.5 %) and 87.9 % (95% CI 77.4–99.9 %), respectively. Adverse events (AEs) were reported in 75 (85 %) patients, among them AEs of grade ≥ 3 in 35 (40 %) patients. Cytokine release syndrome was identified in 33 (38 %) patients, and “flare” syndrome was registered in 14 (16 %) patients. Infectious complications were observed in 45 (51 %) patients. Grade 5 AEs included only COVID-19 infection (n = 7; 8 %). Male gender, early relapse/refractoriness as well as 3-month administration of bendamustine prior to Glofit therapy were associated with the rate of achieving CR. PFS was lower in bendamustine recipients and also in cases with B-symptoms and massive tumor (bulky, > 7.5 cm). CONCLUSION. Glofit demonstrated high efficacy and tolerable toxicity profile in the treatment of R/R DLBCL patients. The results obtained in a real-world setting confirm the data from previously published clinical trials.