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Press Release: Roche presents latest advances -2-

| Quelle: Dow Jones Newsw... | Lesedauer etwa 11 min. | Text vorlesen Stop Pause Fortsetzen
Press Release: Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma



Data for investigational CD20xCD3 bispecific antibodies and new
combination regimens with Polivy showed enhanced clinical benefits for
people with non-Hodgkin lymphoma in early studies


Basel, 4 June 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced
that new data on its investigational CD20xCD3 T-cell engaging bispecific
antibodies, mosunetuzumab and glofitamab, and its first-in-class
anti-CD79b antibody-drug conjugate, Polivy(R) (polatuzumab vedotin), in
non-Hodgkin lymphoma (NHL) will be presented at the 2021 ASCO Annual
Meeting from 4-8 June 2021.

"People with difficult-to-treat blood cancers such as non-Hodgkin
lymphoma still need more options to help improve outcomes," said Levi
Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global
Product Development. "We are encouraged by promising data from our
emerging T-cell engaging bispecific antibodies, mosunetuzumab and
glofitamab, and the antibody-drug conjugate, Polivy, that demonstrate
the potential of these novel immunotherapeutic approaches for various
groups of patients."

While approximately 500,000 people worldwide are diagnosed with NHL each
year, treatment options are currently limited and resistance to existing
therapies or relapse following treatment is common.(1) The most
prevalent form of NHL, accounting for about 40% of newly diagnosed NHL
cases, is an aggressive form called diffuse large B-cell lymphoma
(DLBCL), that comes with a life expectancy of weeks or months if left
untreated.(2,3)

In clinical trials to date, the investigational CD20xCD3 T-cell engaging
bispecific antibodies, mosunetuzumab and glofitamab, have shown
promising responses across multiple types of NHL, including relapsed or
refractory (R/R) DLBCL and follicular lymphoma (FL). Pivotal data for
these medicines are expected this year and Roche is targeting a
regulatory filing for mosunetuzumab in FL by the end of 2021, following
its U.S. Food and Drug Administration Breakthrough Therapy Designation
granted in June 2020. Key data on mosunetuzumab and glofitamab to be
presented at the meeting include:


Phase I NP30179 study investigating step-up dosing of glofitamab in
heavily pre-treated R/R NHL, showed high, ongoing complete responses
(CRs) and an acceptable safety profile. After a median follow-up of 6.3
months, results showed that glofitamab achieved a complete metabolic
response rate, defined as the disappearance of metabolic tumour activity,
of 71.4% in patients with aggressive (fast-growing) NHL. The most common
adverse events (AEs) were cytokine release syndrome (CRS) (63.5%),
neutropenia (38.5%), and pyrexia (32.7%); CRS events were mostly low
grade and confined to the first cycle of treatment.4

Phase I/II GO40516 study of mosunetuzumab in combination with Polivy in
R/R NHL showed promising efficacy and an acceptable safety profile. The
regimen achieved a CR of 54.5% in all patients. Eighty six percent of
patients evaluated had aggressive NHL, and these patients achieved a CR
rate of 47.4%. The most frequent treatment-related AEs were neutropenia
(45.4%), fatigue, nausea, and diarrhoea (all 36.4%) and CRS (9.1%; all
Grade 1).5


Broad development programmes are ongoing for mosunetuzumab and
glofitamab, including the phase III GO42909 trial investigating
mosunetuzumab plus lenalidomide versus MabThera(R)/Rituxan(R)
(rituximab) plus lenalidomide in R/R FL, which will soon be enrolling
patients. For glofitamab, the phase III GO41944 open-label, randomised
trial designed to evaluate the safety and efficacy of glofitamab plus
gemcitabine and oxaliplatin (glofit-GemOx) versus MabThera/Rituxan plus
GemOx in patients with R/R DLBCL, is also ongoing.

Roche is committed to pursuing treatment solutions that can be tailored
to meet the various needs of both people living with NHL and healthcare
professionals. Polivy is already a treatment option for people with R/R
DLBCL and continues to show potential in multiple combinations. Key data
at the meeting include:


New triplet combination of Polivy with MabThera/Rituxan and lenalidomide,
which demonstrated promising activity in difficult-to-treat R/R DLBCL,
based on results from the phase Ib/II GO29834 study. With a median
follow-up of 9.7 months, median overall survival was 10.9 months (95% CI:
7.4NE) and median progression-free survival was 6.3 months (95% CI:
4.59.7) in patients treated with the triplet. The most commonly
reported Grade 3-4 AEs were neutropenia (58.0%), thrombocytopenia (14.0%),
infections (14.0%) and anaemia (11.0%).6


As a leader in haematology development, Roche will continue to follow
the science to expand and improve upon treatment options for healthcare
providers and people with difficult-to-treat blood cancers.

Keep up to date with ASCO news and updates by using the hashtag #ASCO21
and follow Roche on Twitter via @Roche
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and on LinkedIn
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.

About Roche's investigational bispecifics in haematology

Roche is currently developing two T-cell engaging bispecific antibodies,
mosunetuzumab and glofitamab, designed to target CD20 on the surface of
B-cells and CD3 on the surface of T-cells. This dual targeting activates
and redirects a patient's existing T-cells to engage and eliminate
target B-cells by releasing cytotoxic proteins into the B-cells.
Mosunetuzumab and glofitamab differ in their structures, and both are
being developed by Roche as part of our ongoing strategy to explore
multiple bispecific formats, to identify those that maximise potential
clinical benefits for patients. Mosunetuzumab has a structure similar to
that of a natural human antibody in that it has two 'Fab' regions, but
is different from naturally-occurring antibodies in that one 'Fab'
region targets CD20 and the other 'Fab' region targets CD3. Glofitamab
is based on a novel structural format called '2:1', which refers to the
structure of the antibody. It is engineered to have two 'Fab' regions
which bind to CD20, and one 'Fab' region which binds to CD3. The
clinical development programmes for mosunetuzumab and glofitamab include
ongoing investigations of these molecules as monotherapies and in
combination with other medicines, for the treatment of people with
CD20-positive B-cell non-Hodgkin lymphomas (NHL), including diffuse
large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

About Polivy(R) (polatuzumab vedotin)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The
CD79b protein is expressed specifically in the majority of B-cells, an
immune cell impacted in some types of NHL, making it a promising target
for the development of new therapies.(7,8) Polivy binds to CD79b and
destroys these B-cells through the delivery of an anti-cancer agent,
which is thought to minimise the effects on normal cells.(9,10) Polivy
is being developed by Roche using Seagen ADC technology and is currently
being investigated for the treatment of several types of NHL. Polivy is
marketed in the US by Genentech as Polivy (polatuzumab vedotin-piiq),
with piiq as the suffix designated in accordance with Nonproprietary
Naming of Biological Products Guidance for Industry issued by the U.S.
Food and Drug Administration.

About the NP30179 study

The NP30179 study [NCT03075696] is a phase I/Ib, multicentre, open-label,
dose-escalation study, evaluating the efficacy, safety, tolerability and
pharmacokinetics of glofitamab. In this study, glofitamab is assessed as
a single-agent and in combination with Gazyva(R)/Gazyvaro(R)
(obinutuzumab), following pre-treatment with a one-time, fixed-dose of
Gazyva/Gazyvaro, in people with relapsed or refractory (R/R) B-cell NHL.
Outcome measures include overall response rate, complete response rate
per Lugano 2014 criteria, maximum tolerated dose and tolerability.

About the GO40516 study

The GO40516 study [NCT03671018] is a phase I/II, multicentre, open-label
study, evaluating the efficacy, safety, tolerability and
pharmacokinetics of mosunetuzumab in combination with Polivy in people
with B-cell NHL. It consists of a dose finding portion followed by an
expansion phase for second line or later (2L+) participants with R/R
DLBCL and 2L+ R/R FL. Outcome measures include best overall response
rate, maximum tolerated dose and tolerability.

About the GO29834 study

The GO29834 study [NCT02600897] is a phase Ib/II, multicentre,
open-label study, evaluating the efficacy and safety of Polivy with
MabThera(R) /Rituxan(R) (rituximab) and lenalidomide in R/R DLBCL.
Outcome measures include complete response and tolerability.

About Roche in haematology

Roche has been developing medicines for people with malignant and
non-malignant blood diseases for over 20 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, Gazyva/Gazyvaro, Polivy,
Venclexta(R)/Venclyxto(R) (venetoclax) in collaboration with AbbVie, and
Hemlibra(R) (emicizumab). Our pipeline of investigational haematology
medicines includes T-cell engaging bispecific antibodies, glofitamab and
mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting
FcRH5 and CD3; Tecentriq(R) (atezolizumab), a monoclonal antibody
designed to bind with PD-L1; 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

(MORE TO FOLLOW) Dow Jones Newswires

June 04, 2021 08:00 ET ( 12:00 GMT)


unique opportunity to develop combination regimens that aim to improve
the lives of patients even further.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics, as well as growing capabilities in the
area of data-driven medical insights help Roche deliver truly
personalised healthcare. Roche is working with partners across the
healthcare sector to provide the best care for each person.

Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology
and diseases of the central nervous system. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics, and
a frontrunner in diabetes management. In recent years, Roche has
invested in genomic profiling and real-world data partnerships and has
become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent,
diagnose and treat diseases and make a sustainable contribution to
society. The company also aims to improve patient access to medical
innovations by working with all relevant stakeholders. More than thirty
medicines developed by Roche are included in the World Health
Organization Model Lists of Essential Medicines, among them life-saving
antibiotics, antimalarials and cancer medicines. Moreover, for the
twelfth consecutive year, Roche has been recognised as one of the most
sustainable companies in the Pharmaceuticals Industry by the Dow Jones
Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over
100 countries and in 2020 employed more than 100,000 people worldwide.
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF
58.3 billion. 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] GLOBOCAN 2020. World Fact Sheet. [Internet; cited May 2021].
Available from:
http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf


[2] Cancer.Net. Leukemia Lymphoma Non-Hodgkin: Subtype. [Internet;
cited May 2021]. Available from:
https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes

[3] Zhou et al. An enhanced International Prognostic Index (NCCN-IPI)
for patients with diffuse large B-cell lymphoma treated in the rituximab
era (NCCN-IPI) Blood. 2014 Feb 6;123(6):837-42

[4] Carlo Stella C, et al. Glofitamab step-up dosing: updated efficacy
data show high complete response rates in heavily pretreated
relapsed/refractory non-Hodgkin lymphoma patients. Poster presented at:
ASCO Annual Meeting; 2021 Jun 4-8. Abstract #7519.

[5] Budde E, et al. Promising tolerability and efficacy results from
dose-escalation in an ongoing Phase Ib/II study of mosunetuzumab with
polatuzumab vedotin in patients with relapsed/refractory B-cell
non-Hodgkin's lymphoma. Poster presented at: ASCO Annual Meeting; 2021
Jun 4-8. Abstract #7520.

[6] Diefenbach C, et al. Polatuzumab vedotin + rituximab + lenalidomide
in patients with relapsed/refractory diffuse large B-cell lymphoma:
primary analysis of a Phase 1b/2 trial Poster presented at: ASCO Annual
Meeting; 2021 Jun 4-8. Abstract #7512.

[7] Dornan D, et al. Therapeutic potential of an anti-CD79b
antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of
non-Hodgkin lymphoma. Blood 2009;1 14:27 21-29.

[8] Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates
are active in different molecular diffuse large B-cell lymphoma
subtypes. Leukemia 2015; 29:15 78-86.

[9] Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic
payloads to monoclonal antibodies. Bioconjug Chem. 2010;21:5-13.

[10] ADC Review. What are antibody-drug conjugates? [Internet; cited May
2021]. Available from:

https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/


Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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Dr. Nicolas Dunant Patrick Barth
Phone: +41 61 687 05 17 Phone: +41 61 688 44 86
Dr. Barbara von Schnurbein Karsten Kleine
Phone: +41 61 687 89 67 Phone: +41 61 682 28 31
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Phone: +41 79 327 54 74 Phone: +41 61 687 43 05








Roche Investor Relations
Dr. Karl Mahler Jon Kaspar Bayard
Phone: +41 61 68-78503 Phone: +41 61 68-83894
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Phone: +41 61 68-84814 Phone: +41 61 68-72942
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Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: mailto:kalm.loren@gene.com
kalm.loren@gene.com





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