Glofit-Pola in R/R LBCL: Phase Ib/II results

Results from a phase Ib/II trial (NCT03533283) evaluating glofitamab + polatuzumab vedotin (Glofit-Pola) in 129 patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) were recently published in the Journal of Clinical Oncology by Hutchings et al. This trial included patients with high-grade B-cell lymphoma (HGBCL; n = 44) and those who had received previous chimeric antigen receptor (CAR) T-cell therapy (n = 28). 

Key data: Among 129 patients enrolled (median age, 67 years), the independent review committee (IRC)–assessed overall response rate (ORR) was 78.3%, with a complete response (CR) rate of 59.7%. Median progression-free survival (PFS) and overall survival (OS) were 12.3 months and 33.8 months, respectively. The most common adverse event (AE) was cytokine release syndrome (CRS; 43.4%), predominantly Grade 1–2 (41.9%), with one Grade 5 event. Grade 3–4 AEs occurred in 58.9% of patients, with 9.3% experiencing Grade 5 AEs, and 14.7% discontinuing treatment because of AEs.

Key learning: Glofit-Pola demonstrated high efficacy with durable responses and a manageable safety profile in heavily pretreated patients with R/R LBCL, including those with HGBCL and previous CAR T-cell therapy failure, addressing a significant unmet medical need in this aggressive lymphoma subtype. The ongoing phase III SKYGLO trial (NCT06047080) is assessing glofitamab with polatuzumab vedotin + rituximab + cyclophosphamide + doxorubicin + prednisone (Pola-R-CHP) vs Pola-R-CHP in previously untreated LBCL.