Roche (RHHBY) has announced that its Phase III STARGLO study yielded statistically significant and clinically meaningful results for Columvi (glofitamab) when combined with gemcitabine and oxaliplatin (GemOx) in comparison to MabThera/Rituxan (rituximab) combined with GemOx (R-GemOx) for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). These patients had previously received at least one line of therapy and were ineligible for autologous stem cell transplant, or had undergone two or more prior lines of therapy.
The primary analysis of the study confirmed that it met its primary endpoint of overall survival (OS). Patients treated with Columvi plus GemOx showed a statistically significant improvement in survival, with a 41% reduction in the risk of death compared to those treated with R-GemOx. The median overall survival for the Columvi regimen was not reached, whereas it was nine months for the R-GemOx group. The safety profile of the combination treatment appeared consistent with the known safety profiles of each individual medication.
Pre-specified exploratory subgroup analyses indicated consistent results, including across clinically relevant stratification factors such as the line of therapy and outcomes of the most recent therapy. Some regional inconsistencies were noted, but these are challenging to interpret definitively due to the exploratory nature of the analyses and small subgroups with wide confidence intervals.
The Columvi combination also achieved its key secondary endpoints, showing a 63% reduction in the risk of disease progression or death compared to R-GemOx. A follow-up analysis conducted after all patients had completed therapy confirmed the sustained benefit across primary and secondary endpoints.
The median overall survival for patients treated with the Columvi combination was 25.5 months—nearly double the 12.9 months observed in the R-GemOx group. Additionally, more than twice as many patients experienced a complete response with the Columvi combination (58.5% versus 25.3%).
While adverse event (AE) rates were higher in the Columvi combination group compared to the R-GemOx group, this was attributed to the higher median number of cycles received by the Columvi group (11 versus 4). One of the most common adverse events was cytokine release syndrome, which was generally of low grade and primarily occurred during Cycle 1.
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