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Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma

F. Hoffmann-La Roche Ltd /
Longer-term follow-up data demonstrate sustained benefit of polatuzumab
vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* Polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus
bendamustine more than doubled overall survival, compared to
MabThera/Rituxan plus bendamustine alone in the phase Ib/II GO29365 study
* Polatuzumab vedotin has the potential to provide a promising new treatment
option at first   relapse
* Results from the GO29365 study, the first and only randomised study to
suggest a survival benefit for patients not eligible for a haematopoietic
stem cell transplant, will be submitted to health authorities around the
world for approval consideration

Basel, 3 December 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced
longer-term data from the phase Ib/II GO29365 study showing that polatuzumab
vedotin, an investigational anti-CD79b antibody drug conjugate (ADC), in
combination with MabThera®/Rituxan® (rituximab) plus bendamustine (BR),
demonstrated a median overall survival (OS) of over one year compared to the BR
arm (12.4 vs. 4.7 months, HR 0.42; 95% CI 0.24, 0.75), in people with R/R DLBCL
not eligible for a haematopoietic stem cell transplant. OS was an exploratory
endpoint. Adverse events (AEs) were consistent with those seen in previous
studies of polatuzumab vedotin, and of BR, with no new safety signals observed.
These data were presented at the 60th American Society of Hematology (ASH)
Annual Meeting on Saturday 1 December 2018, at 18:15-20:15 PT (Sunday 2 December
2018, 03:15-05:15 CET; abstract #1683).

Treatment with polatuzumab vedotin plus BR resulted in a 66% reduction in risk
of disease progression or death (as measured by investigator-assessed
progression free survival; PFS; HR=0.34; 95% CI 0.2-0.570; p<0.0001), with 40%
achieving a complete response (CR) compared to 18% in the BR arm (primary
endpoint, as measured by positron emission tomography (PET); CR rates assessed
by independent review committee; p=0.026). Furthermore, patients treated with
polatuzumab vedotin plus BR achieved higher CR rates and longer PFS and OS
compared with BR in all subgroups tested, including patients from cell-of-origin
groups, germinal centre B-cell-like and activated B-cell-like, which are
associated with a worse prognosis in DLBCL.

"There is a significant need for new and more effective treatment options for
the approximately 40% of people with diffuse large B-cell lymphoma whose disease
either does not respond to initial treatment or returns - a situation that is
associated with a very poor prognosis that worsens after each relapse," said
Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product
Development. "We are delighted that polatuzumab vedotin has demonstrated
sustained clinical benefits and has the potential to hopefully improve survival
rates in this population. We are working with health authorities to make this
novel regimen available to patients worldwide."

The phase Ib/II GO29365 study is the first and only randomised study to suggest
a survival benefit for R/R DLBCL patients who are ineligible for haematopoietic
stem cell transplant. Results were presented at the 60th ASH, and the data for
the polatuzumab vedotin plus BR arm of the GO29365 study in R/R DLBCL will be
submitted to health authorities around the world for approval consideration.

Polatuzumab vedotin is a first-of-its-kind anti-CD79b ADC currently being
investigated for the treatment of several types of non-Hodgkin lymphoma. It is
the only ADC targeted to CD79b, a protein that is highly specific, expressed in
the majority of types of B-cell malignancies. Polatuzumab vedotin in combination
with BR has been granted Breakthrough Therapy Designation and orphan drug
designation by the US Food and Drug Administration, as well as PRIority
MEdicines designation and orphan drug designation by the European Medicines
Agency, for the treatment of adult patients with R/R DLBCL who are not
candidates for haematopoietic stem cell transplantation.

About the GO29365 study
GO29365 is a global, phase Ib/II study evaluating the safety, tolerability and
activity of polatuzumab vedotin in combination with MabThera/Rituxan (rituximab)
or Gazyva/Gazyvaro (obinutuzumab) plus bendamustine in relapsed or refractory
(R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma. The phase II
stage randomised 80 patients with previously treated R/R DLBCL to receive either
bendamustine plus MabThera/Rituxan (BR), or BR in combination with polatuzumab
vedotin. Patients enrolled had received a median of two prior therapies (a range
of 1-7 prior therapies in the polatuzumab vedotin arm and a range of 1-5 prior
therapies in the BR alone arm). The primary endpoint was complete response (CR)
at the end of treatment, as measured by positron emission tomography (PET) and
assessed by an independent review committee (IRC). Other key endpoints included
objective response (OR; CR and partial response, PR) by investigator and IRC
assessment, best objective response at the end of treatment by investigator
assessment, duration of response (DOR), progression-free survival (PFS), event-
free survival (EFS) and overall survival (OS).

About polatuzumab vedotin
Polatuzumab vedotin is a first-of-its-kind anti-CD79b antibody drug conjugate
(ADC) currently being investigated for the treatment of several subtypes of non-
Hodgkin lymphoma (NHL). The CD79b protein is highly specific and expressed in
the majority of types of B-cell NHL, making it a promising target for the
development of new therapies.[1;2] Polatuzumab vedotin is thought to bind to
CD79b, triggering internalisation of the drug into the cells. This targets the
chemotherapy (which is attached to the monoclonal antibody) to these B-cells.
This process is thought to maximise tumour cell death while potentially
minimising the effects on normal healthy cells. [3;4] Polatuzumab vedotin is
being developed by Roche utilising Seattle Genetics ADC technology.

About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin
lymphoma (NHL), accounting for about one in three cases of NHL. [5] DLBCL is an
aggressive (fast-growing) type of NHL, which is generally responsive to
treatment in the frontline. [6] However, as many as 40% of patients will
relapse, at which time salvage therapy options are limited and survival is
short.[1,4] Approximately 150,000 people worldwide are estimated to be diagnosed
with DLBCL each year. [7]

About Roche in haematology
For more than 20 years, Roche has been developing medicines that redefine
treatment in haematology. Today, we are investing more than ever in our effort
to bring innovative treatment options to people with diseases of the blood. In
addition to approved medicines MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro®
(obinutuzumab), and Venclexta®/Venclyxto® (venetoclax) in collaboration with
AbbVie, Roche's pipeline of investigational haematology medicines includes
Tecentriq® (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab
vedotin/RG7596) and a small molecule which inhibits the interaction of MDM2 with
p53 (idasanutlin/RG7388). Roche's dedication to developing novel molecules in
haematology expands beyond malignancy, with the development of Hemlibra®
(emicizumab), a bispecific monoclonal antibody for the treatment of haemophilia
A.

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 under one roof have made Roche the leader in
personalised healthcare - a strategy that aims to fit the right treatment to
each patient in the best way possible.

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. 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. 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 tenth consecutive year, Roche has been recognised
as the most sustainable company 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 2017 employed about 94,000 people worldwide. In 2017, Roche
invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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] 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; 114:2721-2729.
[2] 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; 29:1578-1586
[3] Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to
monoclonal antibodies. Bioconjug Chem. 2010; 21:5 - 13.
[4] ADC Review. What are antibody-drug conjugates? [Internet; cited 2016 Jan].
Available from: https://adcreview.com/adc-university/adcs-101/antibody-drug-
conjugates-adcs/.
[5] Lyon, France. World Health Organization Classification of Tumors of
Haematopoietic and Lymphoid Tissues. IARC Press; 2008.
[6] Maurer, JM et al. Event-free survival at 24 months is a robust end point for
disease-related outcome in diffuse large B-cell lymphoma treated with
immunochemotherapy. J Clin Oncol 2014; 32:1066-73.
[7] Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality
and prevalence worldwide in 2018. [Internet; cited 2018 May]. Available from:
http://globocan.iarc.fr.


Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow


Roche-Media-Release-ASH_Polatuzumab_EN:
http://hugin.info/174806/R/2227404/874467.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: F. Hoffmann-La Roche Ltd via GlobeNewswire



 
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