Roche has reported findings from the Phase III STARGLO clinical trial where Columvi, in combination with gemcitabine and oxaliplatin (GemOx), significantly extended survival in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
The trial compared this regimen against MabThera/Rituxan (rituximab) combined with GemOx (R-GemOx).
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It enrolled DLBCL patients who were previously treated with a minimum of one line of therapy and did not undergo autologous stem cell transplant, or had received two or more prior lines of therapy.
The open-label, multicentre, randomised study focused on the safety and efficacy of Columvi plus GemOx regimen versus R-GemOx.
Overall survival (OS) was the primary endpoint while secondary endpoints included progression-free survival, complete response rate and duration of objective response.
The primary analysis, with a median follow-up of 11.3 months, confirmed that the study met its primary endpoint of OS.
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By GlobalDataPatients treated with Columvi plus GemOx experienced a 41% reduction in mortality risk compared with those on R-GemOx.
The median OS was not attained in the Columvi group, in contrast to nine months for the R-GemOx group.
The safety profile of the combination regimen appeared to be in line with the known safety profiles of the individual medicines.
Additionally, the Columvi combination met its key secondary endpoints, showing a 63% decline in the disease progression or mortality risk compared with R-GemOx.
Roche Global Product Development head and chief medical officer 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. This could be particularly important for patients with highly aggressive disease who are at risk of rapid disease progression.”
Recently, Roche announced five-year findings from the open-label extension portion of the FIREFISH study, where Evrysdi (risdiplam) offered sustained efficacy and safety in children with type 1 spinal muscular atrophy.
