- Roche's (RHHBY, Financial) Columvi combination therapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) demonstrated a 41% reduction in death risk in a phase III clinical trial.
- The combination therapy showed a 63% reduction in disease progression risk and has already been approved in over 30 countries.
- The FDA's decision on the application is expected by July 20, 2025.
Roche (RHHBY) recently provided an update on its supplemental Biologics License Application for Columvi, in combination with GemOx, which was reviewed by a US Food and Drug Administration (FDA) Advisory Committee. This combination therapy targets individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for autologous stem cell transplant.
The phase III STARGLO study results were pivotal, showing that the Columvi combination reduced the risk of death by 41% compared to standard treatment. Median overall survival was observed at 25.5 months with Columvi, nearly double the 12.9 months noted with standard therapies. Additionally, the therapy presented a 63% reduction in the risk of disease progression.
Despite these promising outcomes, the FDA Advisory Committee has requested additional data to ascertain the applicability of these results to the US patient population. This request underscores the need for detailed clinical applicability assurance before proceeding with regulatory decisions. The final decision from the FDA is anticipated by July 20, 2025.
Currently, Columvi is approved in more than 30 countries and is recognized in the National Comprehensive Cancer Network (NCCN) guidelines as a preferred regimen for specific DLBCL patients. Approximately 75% of patients with relapsed/refractory DLBCL could benefit from this therapy, especially those who lack access to the latest treatments.
However, the treatment is associated with a higher rate of adverse events, notably cytokine release syndrome, experienced by 44.2% of patients, primarily during the first treatment cycle. The treatment's broad clinical development program emphasizes its potential in providing accessible and effective cancer care solutions.
