[Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
15 Avril 2024 - 7:00AM
UK Regulatory
[Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets
primary endpoint of overall survival in people with relapsed or
refractory diffuse large B-cell lymphoma in Phase III STARGLO study
- Columvi, in combination
with chemotherapy, demonstrated a statistically significant
improvement in overall survival for people with relapsed or
refractory diffuse large B-cell lymphoma
- Data from the STARGLO study
will be submitted to health authorities and presented at an
upcoming medical meeting
Basel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the Phase III STARGLO study met its primary
endpoint of overall survival. The study demonstrated that 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, lived
longer when treated with Columvi® (glofitamab) in combination with
gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan®
(rituximab) in combination with GemOx. Safety of the combination
appeared consistent with the known safety profiles of the
individual medicines. The data will be submitted to health
authorities and shared at an upcoming medical meeting.
“People with this aggressive lymphoma facing relapse or
progression after initial treatment have limited options –
particularly those who are ineligible for stem cell transplant,”
said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and
Head of Global Product Development. “Building on Columvi’s
established benefits, these data demonstrate the potential of this
combination regimen to improve survival outcomes in earlier lines
of treatment.”
Columvi was the first fixed-duration bispecific antibody to
receive accelerated approval by the U.S. Food and Drug
Administration and conditional marketing authorisation from the
European Commission to treat people with R/R DLBCL after two or
more lines of systemic therapy. These approvals were based on
positive results of Columvi as a monotherapy from the pivotal Phase
I/II NP30179 study in patients with R/R DLBCL who had previously
received two or more prior treatments.
Columvi is a CD20xCD3 T-cell engaging bispecific antibody
designed to be off-the-shelf and ready for infusion, so patients
can start treatment soon after diagnosis. This is particularly
important for patients with highly aggressive disease who are at
risk of rapid disease progression. Columvi is given as a
fixed-duration treatment, offering people with R/R DLBCL who have
failed two or more lines of therapy a treatment end date and the
possibility of a treatment-free period, unlike continuous
treatments.
About the STARGLO study
The STARGLO study [GO41944; NCT04408638] is a Phase III,
multicentre, open-label, randomised study evaluating the efficacy
and safety of Columvi® (glofitamab) in combination with gemcitabine
plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in
combination with GemOx in patients with diffuse large B-cell
lymphoma who have received at least one prior line of therapy and
who are not candidates for autologous stem cell
transplant.1 Outcome measures include overall survival
(primary endpoint), progression-free survival, complete response
rate, objective response rate, duration of objective response
(secondary endpoints), and safety and tolerability.1
About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed
to target CD3 on the surface of T-cells and CD20 on the surface of
B-cells. Columvi was designed with a novel 2:1 structural format.
This T-cell engaging bispecific antibody is engineered to have one
region that binds to CD3, a protein on T-cells, a type of immune
cell, and two regions that bind to CD20, a protein on B-cells,
which can be healthy or malignant. This dual-targeting brings the
T-cell in close proximity to the B-cell, activating the release of
cancer cell-killing proteins from the T-cell. Columvi is part of
Roche’s broad and industry-leading CD20xCD3 T-cell-engaging
bispecific antibody clinical development programme that also
includes Lunsumio® (mosunetuzumab), which aims to provide tailored
treatment options that suit the diverse needs, preferences, and
experiences of people with blood cancers and healthcare systems.
Roche is investigating Columvi as a monotherapy and in combination
with other medicines, including Polivy® (polatuzumab vedotin), in
earlier lines of treatment for people with B-cell non-Hodgkin
lymphomas, including diffuse large B-cell lymphoma and other blood
cancers.
About diffuse large B-cell lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin lymphoma (NHL),
accounting for about one in three cases of NHL.2 DLBCL
is an aggressive (fast-growing) type of NHL.2 While it
is generally responsive to treatment in the frontline, as many as
40% of people will relapse or have refractory disease, at which
time salvage therapy options are limited and survival is
short.3 Improving treatments earlier in the course of
the disease and providing much needed alternative options could
help to improve long-term outcomes. Approximately 160,000 people
worldwide are diagnosed with DLBCL each
year.2, 4
About Roche in haematology
Roche has been developing medicines for people with malignant and
non-malignant blood diseases for more than 25 years; our experience
and knowledge in this therapeutic area runs deep. Today, we are
investing more than ever in our effort to bring innovative
treatment options to patients across a wide range of haematologic
diseases. Our approved medicines include MabThera®/Rituxan®
(rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab
vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with
AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and
Columvi® (glofitamab). Our pipeline of investigational haematology
medicines includes T-cell engaging bispecific antibody cevostamab,
targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), and
crovalimab, an anti-C5 antibody engineered to optimise complement
inhibition. Our scientific expertise, combined with the breadth of
our portfolio and pipeline, also provides a unique opportunity to
develop combination regimens that aim to improve the lives of
patients even further.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] ClinicalTrials.gov. A Phase III Study Evaluating Glofitamab in
Combination With Gemcitabine + Oxaliplatin vs Rituximab in
Combination With Gemcitabine + Oxaliplatin in Participants With
Relapsed/Refractory Diffuse Large B-Cell Lymphoma: NCT04408638
[Internet; cited April 2024]. Available from:
https://classic.clinicaltrials.gov/ct2/show/NCT04408638.
[2] UpToDate. Patient education: Diffuse large B cell lymphoma in
adults (Beyond the Basics). [Internet; cited April 2024]. Available
from:
https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.
[3] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med.
2021;384(9):842-858.
[4] World Health Organization. Numbers derived from GLOBOCAN 2022.
Non-Hodgkin Lymphoma Factsheet [Internet; cited April 2024].
Available from:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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