Columvi Combo Enhances Survival Outcomes in R/R Lymphoma Subgroup

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), Columvi (glofitamab) plus chemotherapy with gemcitabine and oxaliplatin (GemOx) demonstrated enhanced survival outcomes compared with Rituxan (rituximab) plus GemOx, according to a two-year follow-up data from the phase 3 STARGLO trial presented at the 2025 ASCO Annual Meeting.

Efficacy data from the trial revealed that after a median follow-up of 24.7 months, Columvi plus GemOx exhibited superior overall survival versus Rituxan/GemOx; the median overall survival was not evaluable versus 13.5 months. Additionally, the 24-month overall survival rate in each arm was 54.4% versus 33.6%. The median progression-free survival in each arm was 13.8 months versus 3.6 months, with respective 18-month progression-free survival rates of 46.5% versus 23.0%.

The objective response rates in the Columvi and Rituxan arms were 68.3% versus 40.7%. Furthermore, the complete response rate with Columvi was 58.5% versus 25.3% with Rituxan. Among responders to Columvi, the median duration of complete response was not reached versus 24.2 months for responders to Rituxan. A total of 42.1% of the Columvi arm and 17.6% of the Rituxan arm had an ongoing complete response at data cut-off.

Following the end of treatment, the median overall survival and progression-free survival was not estimable in the Columvi arm. The respective 12-month overall survival and progression-free survival rates were 89.3% and 82.4%.

“With 2-year follow-up data of the [phase 3] STARGLO trial, Columvi/GemOx continues to show a sustained benefit in overall survival, progression-free survival, and response compared to [Rituxan]/GemOx,” Dr. Jeremy S. Abramson, director of the Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital and a professor of Medicine at Harvard Medical School, said in the presentation. “We saw that more than half of patients remain alive after Columvi/GemOx, and the majority of responders were not only alive, but progression-free.”

Patients in the phase 3 trial were randomly assigned to receive Columvi plus GemOx (183 patients) or Rituxan plus GemOx (91 patients). Those in the Columvi arm received step-up dosing in cycle one, then a 30 milligram (mg) target dose every 31 days starting cycle two, day one. Patients were given eight cycles of Columvi with GemOx followed by four cycles of Columvi as monotherapy.

In the Rituxan and Columvi arms, respectively, the median age was 69.0 years (range, 20-84) versus 68.0 years (range, 22-88), 58.2% versus 57.4% of patients were male, and 56.0% versus 47.0% were Asian. A total of 62.6% versus 62.8% had one prior line of therapy, 51.6% versus 57.9% were primary refractory to last treatment, and 90.9% versus 88.9% had an ECOG performance status of zero or one. Furthermore, 77.8% versus 66.7% had Ann Arbor stage 3 or 4 disease, 15.6% versus 12.6% had bulky disease of 10 centimeter or greater, and 8.8% versus 7.7% received prior CAR-T cell therapy.

The primary end point of the trial was overall survival. Secondary end points included independent review committee–assessed progression-free survival and complete response rates, with a landmark analysis of patients with complete responses at end of treatment performed.

Among those treated with Rituxan and Columvi, 17.0% versus 52.3% experienced serious side effects. Furthermore, 40.9% versus 76.7% experienced grade 3 (serious) or higher side effects, including 4.5% versus 7.0% of patients on each respective arm dying. Side effects leading to treatment discontinuation occurred in 12.5% and 25.6% of the Rituxan and Columvi arms.

In the Columvi arm, the incidence of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome was 44.8% and 2.3%, with respective grade 3/4 rates of 2.3% and 0.6%. Infections of any grade occurred in 29.5% and 55.2% of the Rituxan and Columvi arms, respectively, with 9.1% and 16.9% of patients experiencing grade 3 (serious)/4 (life-threatening) infections, and 3.4% versus 3.5% dying from infections.

Reference

Abramson JS, Ku M, Hertzberg M, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. J Clin Oncol. 2025;43(suppl 16):7015. doi:10.1200/JCO.2025.43.16_suppl.7015

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