Swiss healthcare MNC Roche has unveiled the results of its three-year study that shows its Columvi combo doubles survival in patients with hard-to-treat lymphoma.
As per the phase III STARGLO study, Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) dramatically extends survival in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
After a median follow-up of 35.1 months, patients treated with Columvi plus GemOx survived twice as long as those receiving MabThera/Rituxan (rituximab) plus GemOx (R-GemOx)—25.5 months versus 12.5 months (HR=0.60, 95% CI: 0.43-0.8). The findings were presented at the 67th American Society of Hematology Annual Meeting in Orlando.
Subgroup analyses reinforced the benefit across age groups and prior therapies. The greatest impact was seen in patients receiving second-line therapy, with 54.6% alive at 36 months. In this group, median overall survival with Columvi-GemOx was not reached versus 14.4 months for R-GemOx (HR=0.58; 95% CI: 0.38-0.89), while median progression-free survival reached 20.4 months versus 5.5 months (HR=0.41; 95% CI: 0.25-0.65). Even patients with early relapse—typically difficult to treat—achieved a 56.0% complete response rate and a 36-month overall survival of 46.1%.
“At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, Director at the Jon and Jo Ann Hagler Center for Lymphoma at Mass General Brigham Cancer Institute and principal investigator of the STARGLO study.
“These data continue to underscore the meaningful benefit of Glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.”
Roche Chief Medical Officer Levi Garraway, PhD, emphasized the real-world impact: “By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy.
"The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.”
Safety data remained consistent with prior reports, with no new signals observed.
Columvi plus GemOx is approved in over 50 countries, including the EU, UK, Canada, Australia, China, and Mexico, and is recommended by the European Society For Medical Oncology, European Hematology Association, the pharma company said.
The STARGLO trial is a multicenter, open-label, randomized study designed to test the efficacy and safety of Columvi in combination with GemOx versus R-GemOx in patients with R/R DLBCL not eligible for ASCT or who have received multiple prior therapies.
The trial’s primary endpoint is overall survival, with secondary endpoints including progression-free survival, complete response, and safety, as per the company.
