TOPLINE

Glofitamab plus gemcitabine-oxaliplatin (GemOx) was associated with longer overall and progression-free survival than rituximab plus GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplant (ASCT). Serious and grade ≥ 3 adverse events were more common with glofitamab-GemOx, although patients received substantially more treatment with the glofitamab regimen.

METHODOLOGY

• Patients with relapsed or refractory DLBCL who are ineligible for ASCT usually have limited treatment options and may have particularly poor outcomes. The phase 3 STARGLO trial previously showed longer overall survival with fixed-duration glofitamab plus GemOx than with rituximab plus GemOx. This analysis assessed efficacy and safety after 3 years of follow-up.
• Researchers conducted a global, phase 3, open-label, randomized trial of 274 patients with relapsed or refractory DLBCL who were ineligible for ASCT and had received at least one prior systemic therapy. Patients were randomly assigned in a 2:1 ratio to receive either glofitamab plus GemOx (n = 183) or rituximab plus GemOx (n = 91).
• Patients in the glofitamab arm received step-up dosing during cycle 1 followed by fixed-dose glofitamab through cycle 12, with GemOx through cycle 8. Patients in the rituximab arm received rituximab for eight cycles with GemOx.
• The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. The current analysis reported updated efficacy and safety data after 3 years of follow-up.

TAKEAWAY

• After a median follow-up of 35.1 months, glofitamab plus GemOx was associated with longer overall survival than rituximab plus GemOx (median overall survival, 25.5 vs 12.5 months; hazard ratio [HR], 0.60; P < .0018); the 3-year overall survival rates were 47.1% and 27.4%, respectively.
• Progression-free survival was also significantly longer with glofitamab-GemOx than with rituximab-GemOx (median progression-free survival, 14.4 vs 3.3 months; HR, 0.41; P < .000001); the 30-month progression-free survival rates were 38.1% and 15.2%, respectively.
• In exploratory subgroup analyses, the 3-year overall survival rate among patients treated in the second-line setting was 54.6% with glofitamab vs 30.8% with rituximab; among those with primary refractory disease or early treatment failure, the corresponding rates were 46.1% vs 16.5%.
• Serious adverse events were more common with glofitamab (54.4% vs 17.0%), as were grade ≥ 3 adverse events (77.8% vs 45.5%), treatment discontinuations because of adverse events (23.3% vs 11.4%) and an adverse event with a fatal outcome (8.9% vs 4.5%), though treatment exposure was substantially longer in the glofitamab arm (median, 11 vs 4 cycles).

IN PRACTICE

The 3-year findings support glofitamab-GemOx as an effective fixed-duration treatment option for ASCT-ineligible patients with relapsed or refractory DLBCL, the authors of the study concluded.

SOURCE

The study, led by Jeremy S. Abramson of Massachusetts General Hospital Cancer Center in Boston, was published online in Blood Advances.

LIMITATIONS

The study enrolled a selected population of patients with DLBCL who were ineligible for ASCT, limiting generalizability to other patients with relapsed or refractory disease. The trial compared glofitamab-GemOx with rituximab-GemOx rather than with newer cellular or bispecific therapies, so the findings do not establish how the regimen compares with these contemporary treatment approaches. Findings from the second-line and early-treatment-failure subgroups were exploratory and should not be interpreted as definitive evidence that the treatment effect differs across these groups. Treatment exposure was substantially longer with glofitamab-GemOx than with rituximab-GemOx, which is important when comparing crude adverse event rates.

DISCLOSURES

The study was funded by F. Hoffmann-La Roche Ltd. Abramson reported receiving research support, consulting fees, and honoraria from multiple pharmaceutical companies, including F. Hoffmann-La Roche Ltd. Nine authors were employees of F. Hoffmann-La Roche Ltd and held stock or stock options in the company. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.