Roche Provides Update on FDA Advisory Committee Review of Columvi Combination Therapy for Relapsed or Refractory DLBCL
Roche has shared an important regulatory update concerning its investigational treatment for a particularly aggressive form of blood cancer. On May 21, 2025, the Swiss pharmaceutical giant announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) convened to evaluate the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab), a CD20xCD3 T-cell engaging bispecific antibody, when used in combination with the chemotherapy regimen gemcitabine and oxaliplatin (GemOx). This combination therapy is being reviewed for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not considered candidates for autologous stem cell transplant (ASCT).
DLBCL is the most common type of non-Hodgkin lymphoma worldwide and is marked by aggressive growth and rapid disease progression. In patients who relapse after initial therapy or whose disease does not respond to treatment, outcomes are often poor, and treatment options are limited. Many of these patients—estimated to be around 75% in the U.S.—are not eligible for ASCT due to factors such as age, frailty, or lack of response to prior therapies. As a result, the oncology community continues to seek out therapies that are both effective and accessible to these high-risk patients.
At the heart of the ODAC meeting was a discussion around the applicability of data from the Phase III STARGLO study to the U.S. population. STARGLO was a multiregional clinical trial (MRCT) that enrolled 274 patients across 62 centers in 13 countries, including the United States, Australia, and several European nations. Of note, the majority of enrolled participants—52%—were from outside Asia. This distribution has led Roche to assert that the trial population is broadly representative of real-world patients with R/R DLBCL in the U.S. setting.
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and its inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “We believe the STARGLO results are applicable to U.S. patients, with the global study population closely mirroring the real-world clinical profile of DLBCL patients in the U.S., and we will continue working with the FDA on the regulatory path forward.”
Despite the compelling results, members of the FDA’s advisory committee expressed a need for additional data to strengthen the applicability argument and inform the agency’s final decision. However, ODAC’s role is advisory; the final decision on the approval of the Columvi-GemOx regimen rests with the FDA, which is expected to issue a verdict by July 20, 2025.
A Promising Option for a Difficult-to-Treat Patient Population
The STARGLO trial yielded statistically and clinically significant findings. Patients treated with the Columvi plus GemOx regimen showed a 41% reduction in the risk of death compared to those who received rituximab (MabThera®/Rituxan®) plus GemOx (R-GemOx). The hazard ratio (HR) for overall survival (OS) was 0.59, with a 95% confidence interval (CI) of 0.40 to 0.89, and a p-value of 0.011—demonstrating a meaningful survival benefit.
In terms of secondary endpoints, the combination therapy also delivered a remarkable 63% reduction in the risk of disease progression or death (progression-free survival, or PFS), with an HR of 0.37 (95% CI: 0.25–0.55, p<0.0001). Median OS was notably prolonged in the Columvi combination group, reaching 25.5 months, nearly twice as long as the 12.9 months seen in patients receiving the R-GemOx regimen.
While efficacy results were highly encouraging, the safety profile of the Columvi-GemOx combination was also carefully evaluated. The safety data were consistent with known profiles of the individual drugs involved. Patients receiving the Columvi combination were able to tolerate a higher median number of treatment cycles—11 versus just four in the R-GemOx group—due to faster progression in the comparator arm. Adverse events (AEs) were more frequently reported in the Columvi arm, but most were manageable. One commonly observed AE was cytokine release syndrome (CRS), a known risk with T-cell engaging therapies. CRS was typically low grade and occurred primarily during the first cycle of therapy, with Grade 3 events reported in only 2.3% of patients.
Dr. Krish Patel, Director of Lymphoma Research at the Sarah Cannon Research Institute, emphasized the real-world relevance of these findings. “Many of the patients with DLBCL who I see in my clinic are similar to the patients reflected in this study, making the glofitamab-GemOx regimen an important potential treatment option,” he said. “These patients need more effective, readily available treatment options, and the compelling results from STARGLO deliver on this need.”
Global Recognition and Regulatory Progress
The promising results from the STARGLO trial have already led to significant regulatory and clinical milestones globally. Columvi in combination with GemOx has been approved in over 30 countries, including across the European Union, for patients with relapsed or refractory DLBCL who are ineligible for ASCT. Additionally, the regimen was recently incorporated into the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology® as a Category 1 preferred treatment for patients in the second-line setting who are not intended for transplant.
These achievements reflect the growing confidence in Columvi’s ability to address a substantial unmet need in lymphoma care. Columvi monotherapy had already received accelerated approval in the United States for the treatment of R/R DLBCL after at least two prior lines of therapy. The STARGLO study was designed as a confirmatory trial to transition Columvi from accelerated to full FDA approval, a critical step in the drug’s lifecycle.
Roche has continued to invest in the broader clinical development of Columvi, exploring its use across various lines of therapy and in combination with other agents. Importantly, evidence to date suggests that neither geographic region nor racial background significantly influences the efficacy of treatment with Columvi, reinforcing its potential as a globally applicable therapy.
As the FDA deliberates its final decision, Roche remains committed to supporting the review process with additional data and clarifications as needed. A key upcoming milestone will be the presentation of two-year follow-up data from the STARGLO trial at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3, 2025. These results will provide valuable insight into the durability of the Columvi combination’s benefits and may further inform regulators and clinicians alike.
The ODAC meeting underscores the complexity of regulatory decision-making in oncology, particularly when multinational trials are used to support approval in specific local populations. Nevertheless, the need for effective and scalable treatments for relapsed or refractory DLBCL remains urgent, and the Columvi-GemOx combination could become a cornerstone of care for patients ineligible for transplant.
As Dr. Garraway concluded, “Our goal is to bring transformative medicines to patients who need them most. We believe the totality of evidence from the STARGLO study demonstrates that the Columvi combination can make a meaningful difference in the lives of patients with relapsed or refractory DLBCL, and we look forward to the FDA’s decision.”
