Roche's Columvi approved by EC for treating large B-cell lymphoma

Roche's Columvi (glofitamab) has recently received approval from the European Commission (EC) for use in combination therapy targeting diffuse large B-cell lymphoma (DLBCL). This bispecific antibody, which targets CD20xCD3 T-cells, is set to be used alongside gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory DLBCL who are not suitable candidates for autologous stem cell transplantation.

DLBCL is a highly aggressive subtype of non-Hodgkin lymphoma, impacting approximately 38,000 people each year across Europe. While initial treatments for DLBCL are often effective, nearly 40% of patients eventually experience a relapse or develop refractory conditions, leaving them with limited options for further treatment and significantly reduced survival chances.

Columvi offers a fixed-duration treatment plan, which not only gives patients a definitive endpoint for their therapy but also allows for intervals free from treatment. Its design as an "off-the-shelf" therapy means treatment can commence soon after a diagnosis, providing a crucial advantage in managing the disease's progression.

The European Commission's conditional marketing authorization for Columvi in 2023 was a significant milestone, focusing on patients who had undergone two or more systemic therapies for relapsed or refractory DLBCL. The recent approval further advances this authorization, supported by promising data from the phase 3 STARGLO trial. This trial demonstrated that the combination of Columvi with GemOx significantly enhanced overall survival rates compared to the conventional treatment regimen of rituximab plus GemOx (R-GemOx).

The trial results revealed that the Columvi combination reduced the risk of death by 41% and the risk of disease worsening or death by 63% compared to the R-GemOx regimen. Moreover, patients treated with the Columvi regimen had a median overall survival of 25.5 months, a substantial improvement over the 12.9 months observed in the R-GemOx group. Furthermore, more than twice as many patients achieved a complete response when treated with Roche’s combination therapy.

Levi Garraway, Roche’s chief medical officer and head of global product development, emphasized the significance of this development. He stated that Columvi represents a breakthrough in treatment for individuals whose DLBCL has returned following initial therapy. The recent approval means that Columvi can now be introduced earlier in the treatment process, enhancing its role as a critical therapeutic option for DLBCL patients.

In summary, the approval of Columvi by the European Commission marks a pivotal advancement in the treatment landscape for DLBCL. By offering a new combination therapy option that improves survival outcomes, this development holds promise for improving the quality of life and extending survival for patients facing this challenging lymphoma subtype. The ability to initiate treatment promptly and the potential for treatment-free periods further underline the therapeutic value of Columvi, making it a noteworthy addition to the arsenal against aggressive lymphomas.