Genentech announces two-year follow-up data from STARGLO study

Genentech, a member of Roche (RHHBY), announces two-year follow-up data from the Phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival for patients treated with Columvi in combination with gemcitabine and oxaliplatin and median OS was not reached, compared to 13.5 months for Rituxan plus GemOx. These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. Data will be presented in an oral session at the 61st American Society of Clinical Oncology, May 30 – June 3. The benefit across key secondary endpoints, including progression-free survival and complete remission, was maintained for patients treated with the Columvi combination. There was a 59% reduction in the risk of disease progression or death and more than twice as many patients sustained a CR. Among patients with a CR at the end of the treatment period, 89% were alive and 82% had maintained remission one year after treatment. Safety of the combination remained unchanged from the previous analysis and was consistent with the known safety profiles of the individual medicines. Patients received a higher median number of cycles of the Columvi combination, due to disease progression in the R-GemOx arm. A higher rate of adverse events was observed with the Columvi regimen. One of the most common AEs was cytokine release syndrome, which was generally low grade. Given the wide adoption of global treatment guidelines in real-world clinical practice, there are no biological or clinical differences in DLBCL management worldwide. While second-line therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies. There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes. Based on the STARGLO data, this Columvi combination is approved in more than 30 countries for people with R/R DLBCL who are not candidates for ASCT, including countries throughout the EU. Columvi in combination with GemOx was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who are not intended to proceed to transplant. Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide. Columvi is part of Genentech’s industry-leading CD20xCD3 bispecific antibody program. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Genentech aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems.