SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced statistically
significant and clinically meaningful results from its Phase III STARGLO study
of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx)
versus MabThera/Rituxan (rituximab) in combination with GemOx (R-GemOx) for
people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
who have received at least one prior line of therapy and are not candidates for
autologous stem cell transplant, or who have received two or more prior lines of
therapy.

The primary analysis confirmed that the study met its primary endpoint of
overall survival (OS), demonstrating that patients treated with Columvi plus
GemOx lived significantly longer, with a 41% reduction in the risk of death
versus R-GemOx. Median overall survival was not reached with the Columvi regimen
versus nine months for R-GemOx. Safety of the combination appeared consistent
with the known safety profiles of the individual medicines.

Pre-specified exploratory subgroup analyses showed comparable results, including
consistency across the clinically relevant stratification factors of line of
therapy and outcome of last therapy. Regional inconsistencies were observed,
however interpretation is limited given the exploratory nature of these analyses
and small subgroups with wide confidence intervals.

The Columvi combination also met its key secondary endpoints, with a 63%
reduction in risk of disease worsening or death compared to R-GemOx. A follow-up
analysis was conducted after all patients had completed therapy, which showed
continued benefit in both primary and secondary endpoints.

Median overall survival for people treated with the Columvi combination was 25.5
months, nearly double what was seen for people treated with R-GemOx at 12.9
months, and more than twice as many patients experienced a complete response
(58.5% versus 25.3%, respectively).

Adverse event rates were higher with the Columvi combination versus R-GemOx,
noting higher median number of cycles received with Columvi combination (11
versus 4). One of the most common AEs was cytokine release syndrome, which was
generally low grade and occurred primarily in Cycle 1.

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