* The study met its primary endpoint of overall survival with a 41% reduction

    in the risk of death in people with relapsed or refractory (R/R) diffuse
    large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy(1)

* This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL
* Data were featured in the congress Press Briefing and presented today in the Plenary Abstracts Session at EHA 2024 as a late-breaking oral presentation
Basel, 15 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today
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.(1) Data were featured in the congress Press
Briefing and presented today in the Plenary Abstracts Session at the European
Hematology Association (EHA) 2024 Congress as a late-breaking oral
presentation.(1)
"The results from STARGLO are the first to show the potential of a CD20xCD3
bispecific antibody to make a difference in second or later-line DLBCL in people
who are ineligible for transplant and have limited options," said Jeremy
Abramson, M.D., Director, Jon and Jo Ann Hagler Center for Lymphoma at the
Massachusetts General Hospital Cancer Center, and principal investigator of the
STARGLO study. "Glofitamab in combination with GemOx showed clinically
significant improvement in overall survival, as well as key secondary endpoints,
and the benefits were reinforced with an additional 11 months of follow-up."
The primary analysis (median follow-up of 11.3 months) 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 (hazard ratio (HR)=0.59, 95% CI: 0.40-0.89, p=0.011) versus
R-GemOx.(1) Median OS was not reached with the Columvi regimen versus nine
months for R-GemOx.(1 )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 (second-line versus third-line+) and outcome of last therapy (relapsed
versus refractory). Regional inconsistencies were observed, however
interpretation is limited given the exploratory nature of these analyses and
small subgroups with wide confidence intervals.
"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," said Levi Garraway, M.D.,
Ph.D., Roche's Chief Medical Officer and Head of Global Product Development.
"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."
The Columvi combination also met its key secondary endpoints, with a 63%
reduction in risk of disease worsening or death (progression-free survival, PFS)
compared to R-GemOx (HR=0.37; 95% CI: 0.25-0.55, pÂ