In an Australian phase II trial (COALITION) reported in the Journal of Clinical Oncology, Minson et al investigated the addition of glofitamab to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) as first-line therapy in younger patients with high-risk large B-cell lymphoma (LBCL).
Study Details
In the multicenter open-label trial, 80 patients aged ≤ 65 years (median = 58 years) received one cycle of R-CHOP and were randomly assigned between July 2021 and July 2023 to receive five cycles of glofitamab plus either R-CHOP (n = 40) or Pola-R-CHP (n = 40), followed by two cycles of glofitamab consolidation.
Key Findings
Median follow-up was 20.7 months.
Among all patients, the overall response rate was 100%, with complete metabolic response in 98%; a partial metabolic response was observed in one patient in each group.
Among all patients, 2-year progression-free survival was 86% (95% confidence interval [CI] = 75%–93%), including 86% (95% CI = 69%–94%) in the glofitamab plus R-CHOP group and 86% (95% CI = 65%–95%) in the glofitamab plus Pola-R-CHP group.
Among all patients, 2-year overall survival was 92% (95% CI = 80%–97%), including 92% (95% CI = 76%–97%) in the glofitamab plus R-CHOP group and 91% (95% CI = 67%–98%) in the glofitamab plus Pola-R-CHP group.
Grade ≥ 3 adverse events occurred in 56% of patients in both the R-CHOP group and the Pola-R-CHP group, including infection in 19% of all patients (15% and 23%). Serious adverse events occurred in 46% of all patients (43% and 50%). Cytokine-release syndrome was observed in 21% of all patients (20% and 23%; all grade ≤ 2).
The investigators concluded: “The combination of glofitamab with R-CHOP or Pola-R-CHP is deliverable and results in high rates of durable response in this population of younger patients with high-burden, [high-risk LBCL], supporting its ongoing exploration as a [first-line] treatment.”
Michael J. Dickinson, MBBS, DMSc, of Peter MacCallum Cancer Centre, Melbourne, Australia, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by F. Hoffmann–La Roche, Roche Diagnostics, and others. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
