Roche’s Three-Year STARGLO Data Confirm Long-Term Survival Advantage Of Columvi + GemOx In R/R DLBCL; Sustains Strong Efficacy And Safety, Reinforcing Global Adoption

Roche has released three-year follow-up results from the pivotal phase III STARGLO trial evaluating Columvi® (glofitamab) plus gemcitabine and oxaliplatin (GemOx) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant. After a median follow-up of 35.1 months, overall survival for patients receiving the Columvi-based regimen remained double that of those treated with rituximab plus GemOx, demonstrating a median survival of 25.5 months versus 12.5 months.

“At three years, we see flattening of the overall survival curve, suggesting the possibility of a cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, 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.”

The benefit was consistent across clinically relevant subgroups, with the most pronounced outcomes seen in patients receiving the treatment as a second-line option. In this group, more than half of patients were alive at 36 months, and median overall survival had not yet been reached for the Columvi arm. Progression-free survival was also significantly longer, at 20.4 months compared to 5.5 months. Even among patients with early relapse, often among the hardest to treat, the combination produced high complete response rates.

These updated results reinforce the value of Columvi plus GemOx as an accessible, off-the-shelf treatment option for patients who are not transplant candidates or who face barriers to other therapies. Its fixed-duration design also supports more rapid treatment initiation and the possibility of a treatment-free interval. The safety profile remained stable over the extended follow-up period, with no new safety signals and cytokine release syndrome continuing as the most common adverse event.

“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

Columvi in combination with GemOx is now approved in more than 50 countries based on STARGLO data and is included in major oncology guidelines. While the U.S. FDA issued a Complete Response Letter for the regimen, Roche is advancing additional studies across first-line DLBCL and mantle cell lymphoma. Ongoing phase III programs, including SKYGLO and GLOBRYTE, aim to further expand Columvi’s role across B-cell malignancies.