Roche Presents Positive ODAC Discussion on Columvi® Combination Therapy for Aggressive Lymphoma
Basel, Switzerland – May 21, 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) held a discussion on the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx). The treatment targets adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT).
ODAC’s meeting focused on whether data from the global phase III STARGLO trial is applicable to the U.S. patient population. While the committee expressed the need for additional data, Roche emphasized that the study’s global participants—52% of whom were enrolled outside Asia, including U.S. patients—closely reflect the clinical profile of American patients.
“Columvi combined with GemOx showed a 41% reduction in risk of death in the STARGLO study, leading to European approval and recognition as a Category 1 preferred regimen by the U.S. National Comprehensive Cancer Network (NCCN),” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We are confident in the data’s relevance to the U.S. and will continue working closely with the FDA.”
The STARGLO trial enrolled 274 patients across 62 sites in 13 countries, including the U.S., Australia, and various European nations. The study demonstrated:
- 41% reduction in risk of death compared to rituximab plus GemOx (R-GemOx) (HR=0.59, 95% CI: 0.40–0.89; p=0.011).
- 63% reduction in risk of disease progression or death (PFS) (HR=0.37; 95% CI: 0.25–0.55; p<0.0001).
- Median overall survival (OS) of 25.5 months with the Columvi combination vs. 12.9 months with R-GemOx (HR=0.62; 95% CI: 0.43–0.88).
The safety profile was consistent with known risks of the individual drugs. Cytokine release syndrome (CRS), a common adverse event, occurred mainly in the first treatment cycle and was typically low-grade.
Dr. Krish Patel, Director of Lymphoma Research at the Sarah Cannon Research Institute, noted: “Many of my DLBCL patients mirror those in the STARGLO study, making the Columvi-GemOx regimen a promising treatment option. These patients urgently need therapies that are both effective and accessible.”
In the U.S., around 75% of patients with R/R DLBCL are ineligible for transplants or newer treatments due to age, frailty, or access barriers. This highlights the need for effective therapies suitable for use in community settings.
The Columvi-GemOx combination is approved in over 30 countries, including those in the EU, and was recently added to the NCCN Guidelines® as a Category 1 preferred treatment for second-line DLBCL in patients not proceeding to transplant. Columvi monotherapy is already approved in more than 60 countries, including the U.S., for patients who have undergone two or more prior treatments.
STARGLO is designed to support full FDA approval by confirming the benefit of Columvi following its initial accelerated approval. A decision from the FDA is expected by July 20, 2025. Additionally, updated two-year data from STARGLO will be presented at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 to June 3, 2025.
While ODAC’s feedback is non-binding, it plays a key role in shaping the FDA’s final decision.
About the STARGLO study
The STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.
About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma.
As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080].
About diffuse large B-cell lymphoma (DLBCL)
DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.7 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.8,9 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.9-12 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.4,13 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
