Glofitamab as a salvage treatment for B-cell lymphomas in the real world: A multicenter study in Taiwan
Menée à Taïwan dans un contexte de vie réelle à partir de données portant sur 34 patients atteints d'un lymphome à cellules B réfractaire ou récidivant (durée médiane de suivi : 15,9 mois), cette étude multicentrique rétrospective évalue l'efficacité, du point de vue du taux de réponse, du taux de rémission complète et de la survie sans progression, et la toxicité du glofitamab (un anticorps bispécifique ciblant le récepteur CD20 des lymphocytes B et le récepteur CD3 des lymphocytes T) en traitement de sauvetage dans le cadre d'un programme d'usage compassionnel après l'échec d'au moins 3 lignes thérapeutiques antérieures
Background: Glofitamab is a bispecific antibody with promise for treating relapsed/refractory B-cell lymphoma according to a phase 1/2 clinical trial. This study examined its real-world effectiveness. Methods: This was an investigator-initiated, multicenter retrospective study including 34 patients who had relapsed/refractory B-cell lymphomas after at least three prior lines of therapy and received glofitamab monotherapy in a compassionate use program in Taiwan between January 2021 and October 2022. Results: At a median follow-up of 15.9 months, 56% of patients responded to glofitamab and 23% achieved complete remission. Response to the previous line of therapy significantly correlated with response to glofitamab (p = .020). Most responses were durable; only five out of the 19 responders had documented disease recurrence at the data cutoff date. The estimated progression-free survival (PFS) was 3.2 months, and the estimated 1-year PFS was 33% for the entire cohort. PFS was better for responders than nonresponders (median PFS, 16.9 vs. 1.8 months; 1-year PFS, 60% vs. 0%). Forty-three cytokine release syndrome (CRS) events were observed, three of which were grade 3; all were manageable without glofitamab discontinuation. No immune effector cell–associated neurotoxicity was reported. Among seven hepatitis B virus (HBV) carriers (six had antiviral prophylaxis) and 14 patients with remote HBV (four had antiviral prophylaxis), no HBV reactivation was observed. Conclusions: In this real-world cohort, glofitamab exhibited effectiveness comparable to trial results without excessive CRS or new safety issues. With appropriate prophylaxis, glofitamab-treated patients with chronic or remote HBV infection are unlikely to experience virus reactivation.