Roche's Columvi Combo Approved by EC for DLBCL

Roche has achieved a significant milestone with the European Commission's approval of Columvi (glofitamab) combined with gemcitabine and oxaliplatin (GemOx) for the treatment of adults suffering from relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This green light allows the use of this combination in patients who are not suitable candidates for autologous stem cell transplants.

This combination marks the first bispecific antibody regimen authorized for DLBCL in Europe. The approval follows a conditional marketing authorization initially granted in July 2023, which was a stepping stone to achieving a standard approval status. The pivotal Phase III STARGLO trial played a crucial role in gaining this approval, as its findings revealed that Columvi combined with GemOx significantly extended overall survival rates for patients compared to the conventional MabThera/Rituxan (rituximab) with GemOx (R-GemOx) treatment.

One of the key advantages of the Columvi and GemOx regimen is its ready-to-use nature, allowing it to be administered as an off-the-shelf treatment. This is particularly beneficial in avoiding treatment initiation delays, ensuring patients receive timely care. Columvi, along with Lunsumio (mosunetuzumab), is part of Roche's broader initiative involving the cluster of differentiation 20 (CD20)xCD3 bispecific antibody program.

Levi Garraway, who leads Roche's Global Product Development and serves as its chief medical officer, highlighted the significance of Columvi as a groundbreaking treatment that enhances survival rates for those with DLBCL whose cancer has recurred following initial therapy. The recent approval enables Columvi to extend its benefits to patients at an earlier stage of treatment, solidifying its role as a critical therapy for DLBCL.

Roche's strategic direction includes the development of allogeneic CAR T-therapies, aiming to provide personalized treatment solutions that cater to the varying needs of blood cancer patients. Columvi itself is ingeniously designed with a 2:1 structural format that targets CD3 on T cells and CD20 on B cells, maximizing its therapeutic potential.

In its continued efforts to expand Columvi's applicability, Roche is investigating its use both as a standalone treatment and in combination with other drugs for treating mantle cell lymphoma and DLBCL. Notably, the Phase III SKYGLO study is examining Columvi in conjunction with Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for patients with untreated DLBCL. The aim is to improve long-term outcomes and prevent relapse.

Roche's commitment to advancing cancer treatment is further exemplified by its partnership with Oxford BioTherapeutics (OBT), established in March 2025. This multi-year collaboration focuses on developing antibody-based therapeutics to tackle cancer, reflecting Roche's ongoing dedication to innovating in the realm of oncology. Through these efforts, Roche seeks to offer comprehensive and tailored therapeutic options for patients worldwide, addressing the complex needs of those battling blood cancers.