Roche has reported statistically significant and clinically meaningful results from its Phase 3 STARGLO study of Columvi (glofitamab) combination for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Columvi is a bispecific antibody that engages CD20 on B-cell surfaces and CD3 on T-cell surfaces.
STARGLO was evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) against MabThera/Rituxan (rituximab) in combination with GemOx (R-GemOx).
It assessed DLBCL patients who were previously treated with a minimum of one prior line of therapy, did not undergo autologous stem cell transplant, or who have received two or more prior lines of therapy.
The primary endpoint was defined as overall survival (OS) while secondary endpoints included progression-free survival, complete response rate, and duration of objective response.
The primary analysis confirmed the trial’s primary objective of overall survival (OS).
Patients treated with Columvi in combination with GemOx experienced a significant extension in survival, showing a 41% reduction in the risk of death compared to those receiving R-GemOx.
Median OS was not reached with the Columvi regimen, while it was nine months with R-GemOx.
Safety observations were similar to the established safety profiles of both medications used individually.
In addition, pre-specified exploratory subgroup analyses demonstrated comparable results. It also included consistency across the clinically relevant stratification factors of the line of therapy and the outcome of the last therapy.
The Columvi combination also achieved significant success in its key secondary endpoints, demonstrating a 63% reduction in the risk of disease progression or death compared to R-GemOx.
Roche chief medical officer and global product development head Levi Garraway said: “This marks a first step in advancing Columvi combinations in earlier settings to address the urgent need for the 40% of people who will relapse or have refractory disease and who have limited options.
“Moreover, patients do not have to wait to start treatment with Columvi.”
The results will be submitted to global health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The bispecific antibody is also under investigation for other aggressive and difficult-to-treat lymphomas.
Recently, it received Breakthrough Therapy Designation from the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
