Columvi combo enhances survival outcomes vs Rituxan combo in R/R DLBCL: © inventory.adobe.com.
Amongst sufferers with relapsed/refractory diffuse giant B-cell lymphoma (DLBCL), Columvi (glofitamab) plus chemotherapy with gemcitabine and oxaliplatin (GemOx) demonstrated enhanced survival outcomes in contrast with Rituxan (rituximab) plus GemOx, in line with a two-year follow-up knowledge from the part 3 STARGLO trial introduced on the 2025 ASCO Annual Assembly.
Efficacy knowledge from the trial revealed that after a median follow-up of 24.7 months, Columvi plus GemOx exhibited superior total survival versus Rituxan/GemOx; the median total survival was not evaluable versus 13.5 months. Moreover, the 24-month total survival charge in every arm was 54.4% versus 33.6%. The median progression-free survival in every arm was 13.8 months versus 3.6 months, with respective 18-month progression-free survival charges of 46.5% versus 23.0%.
The target response charges within the Columvi and Rituxan arms had been 68.3% versus 40.7%. Moreover, the entire response charge with Columvi was 58.5% versus 25.3% with Rituxan. Amongst responders to Columvi, the median period of full response was not reached versus 24.2 months for responders to Rituxan. A complete of 42.1% of the Columvi arm and 17.6% of the Rituxan arm had an ongoing full response at knowledge cut-off.
Following the tip of therapy, the median total survival and progression-free survival was not estimable within the Columvi arm. The respective 12-month total survival and progression-free survival charges had been 89.3% and 82.4%.
“With 2-year follow-up knowledge of the [phase 3] STARGLO trial, Columvi/GemOx continues to indicate a sustained profit in total survival, progression-free survival, and response in comparison with [Rituxan]/GemOx,” Dr. Jeremy S. Abramson, director of the Jon and Jo Ann Hagler Middle for Lymphoma on the Massachusetts Normal Hospital and a professor of Drugs at Harvard Medical College, stated within the presentation. “We noticed that greater than half of sufferers stay alive after Columvi/GemOx, and the vast majority of responders weren’t solely alive, however progression-free.”
Sufferers within the part 3 trial had been randomly assigned to obtain Columvi plus GemOx (183 sufferers) or Rituxan plus GemOx (91 sufferers). These within the Columvi arm obtained step-up dosing in cycle one, then a 30 milligram (mg) goal dose each 31 days beginning cycle two, day one. Sufferers got eight cycles of Columvi with GemOx adopted by 4 cycles of Columvi as monotherapy.
Within the Rituxan and Columvi arms, respectively, the median age was 69.0 years (vary, 20-84) versus 68.0 years (vary, 22-88), 58.2% versus 57.4% of sufferers had been male, and 56.0% versus 47.0% had been Asian. A complete of 62.6% versus 62.8% had one prior line of remedy, 51.6% versus 57.9% had been major refractory to final therapy, and 90.9% versus 88.9% had an ECOG efficiency standing of zero or one. Moreover, 77.8% versus 66.7% had Ann Arbor stage 3 or 4 illness, 15.6% versus 12.6% had cumbersome illness of 10 centimeter or better, and eight.8% versus 7.7% obtained prior CAR-T cell remedy.
The first finish level of the trial was total survival. Secondary finish factors included impartial overview committee–assessed progression-free survival and full response charges, with a landmark evaluation of sufferers with full responses at finish of therapy carried out.
Amongst these handled with Rituxan and Columvi, 17.0% versus 52.3% skilled critical negative effects. Moreover, 40.9% versus 76.7% skilled grade 3 (critical) or larger negative effects, together with 4.5% versus 7.0% of sufferers on every respective arm dying. Unwanted side effects resulting in therapy discontinuation occurred in 12.5% and 25.6% of the Rituxan and Columvi arms.
Within the Columvi arm, the incidence of cytokine launch syndrome and immune effector cell-associated neurotoxicity syndrome was 44.8% and a pair of.3%, with respective grade 3/4 charges of two.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 sufferers experiencing grade 3 (critical)/4 (life-threatening) infections, and three.4% versus 3.5% dying from infections.
Reference
Abramson JS, Ku M, Hertzberg M, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in sufferers (pts) with relapsed/refractory (R/R) diffuse giant 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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