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New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia

F. Hoffmann-La Roche Ltd /
New Venclexta/Venclyxto data demonstrate deep responses in two of the most
common types of leukaemia
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* New analyses from the phase III MURANO study in previously treated chronic
lymphocytic leukaemia show continued benefit from fixed-duration regimen
after a median follow-up of three years
* Updated results from two studies in newly-diagnosed acute myeloid leukaemia
demonstrate Venclexta combinations continued high rates of deep remission

Basel, 4 December 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new
data from the Venclexta®/Venclyxto® (venetoclax) clinical development programme,
including longer-term results from the phase III MURANO study in people with
previously treated chronic lymphocytic leukaemia (CLL) and updated data from two
phase Ib/II studies in people with previously untreated acute myeloid leukaemia
(AML) ineligible for intensive chemotherapy due to coexisting medical
conditions. Data from the Venclexta/Venclyxto clinical development programme
that ranges across multiple blood cancers, including CLL, AML, non-Hodgkin
lymphoma and multiple myeloma, will be featured in more than 30 abstracts,
including 12 oral presentations, at the 60th American Society of Hematology
(ASH) 2018 Annual Meeting.

"We're excited by the versatility of Venclexta/Venclyxto in treating a range of
distinct types of blood cancer, including difficult-to-treat forms with limited
options," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of
Global Product Development. "These data support our broad clinical development
programme through which we hope to discover more ways Venclexta/Venclyxto can be
used alone or in combination with other medicines to treat additional types of
cancer."

Updated data in CLL
Two new analyses of the phase III MURANO study in relapsed or refractory (R/R)
CLL demonstrated the continued clinical benefit of Venclexta/Venclyxto plus
MabThera®/Rituxan® (rituximab) was sustained after patients completed the
chemotherapy-free, two-year fixed-duration course of therapy.
* An analysis showed the combination reduced the risk of disease progression
or death (progression-free survival; PFS, as assessed by investigator) by
84% (HR=0.16; 95% CI: 0.12-0.23; p<0.0001) compared to standard of care
bendamustine plus MabThera/Rituxan (BR) after a median three-year follow-up.
At three years, 71% of patients in the Venclexta/Venclyxto plus
MabThera/Rituxan arm had not experienced disease progression, compared to
15% of patients in the BR arm (median PFS: not reached vs. 17.0 months,
respectively). A clinically meaningful benefit in overall survival was also
observed in the Venclexta/Venclyxto arm compared to the BR arm (88% vs.
80%, HR=0.50; 95 percent CI: 0.30-0.85). Consistent benefit was observed in
all patient subgroups for Venclexta/Venclyxto plus MabThera/Rituxan compared
to BR, including high-risk and low-risk groups. Data were presented in an
oral session on Saturday, 1 December at 14:45 PST (Abstract #184).
* A separate analysis showed higher rates of minimal residual disease (MRD)-
negativity observed with Venclexta/Venclyxto plus MabThera/Rituxan compared
to BR were sustained after patients completed treatment (62% vs. 13%). MRD-
negativity means no cancer can be detected using a specific, highly
sensitive test, and was defined as less than 1 CLL cell in 10,000
leukocytes. Importantly, these results were observed in the majority of
patients in the Venclexta/Venclyxto arm, including patients in high-risk
subgroups and were consistent with the maintained PFS benefit seen with
longer follow-up. These data support the utility of MRD in peripheral blood
as a predictive marker of clinical outcome. No new safety signals were
observed with the treatment combination of Venclexta/Venclyxto plus
MabThera/Rituxan. These data will be presented in an oral session on Monday,
3 December at 11:30 PST (Abstract #695).

Updated data in AML
Updated data from the phase Ib M14-358 and phase I/II M14-387 studies evaluating
Venclexta/Venclyxto in combination with a hypomethylating agent or low-dose
cytarabine (LDAC) in people with previously untreated AML who are ineligible for
intensive chemotherapy, will also be presented. These results showed that among
patients who were dependent upon blood transfusions at baseline, about half were
able to achieve transfusion independence (the absence of transfusions during any
consecutive 56 days during the study treatment period). No unexpected safety
signals were observed with Venclexta/Venclxyto in combination with
hypomethylating agents or LDAC.
* The M14-358 study showed high rates of complete remission (with at least
partial blood count recovery, CR+CRh) of 67% for those who received
Venclexta/Venclyxto plus azacitidine and 71% for those who received
Venclexta/Venclyxto plus decitabine. For people taking Venclexta/Venclyxto
and azacitadine or decitabine who were dependent on blood transfusions at
baseline, 50% and 52% achieved red blood cell transfusion independence,
respectively; and 58% or 60% achieved platelet transfusion independence,
respectively.
* The M14-387 study showed rates of complete remission (with or without full
recovery of normal blood cell count, CR+CRi) of 54% in people who received
Venclexta/Venclyxto in combination with LDAC and a median duration of
remission of 8.1 months. For people taking Venclexta/Venclyxto with LDAC,
48% achieved red blood cell transfusion independence and 60% achieved
platelet transfusion independence.
Results from the two studies were presented in an oral session on Sunday,
December 2 at 7:45 PST and 8:00 PST, respectively (Abstract #284 and #285).

Based on earlier results from the M14-358 and M14-387 studies, Venclexta was
granted accelerated approval by the US Food and Drug Administration (FDA) for
the treatment of people with newly-diagnosed AML who are age 75 years or older,
or for those ineligible for intensive induction chemotherapy due to coexisting
medical conditions. A robust clinical development programme for
Venclexta/Venclyxto in AML is ongoing, including two ongoing phase III studies
evaluating Venclexta/Venclyxto in combination with azacitidine or with LDAC for
people with previously untreated AML who are ineligible for intensive
chemotherapy based on results from the M14-358 and M14-387 studies.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly
commercialised by AbbVie and Genentech, a member of the Roche Group, in the
United States, and commercialised by AbbVie outside of the United States.

About the MURANO study
MURANO (NCT02005471) is a phase III open-label, international, multicentre,
randomised study evaluating the efficacy and safety of Venclexta/Venclyxto in
combination with MabThera/Rituxan compared to bendamustine in combination with
MabThera/Rituxan (BR) in patients with relapsed or refractory chronic
lymphocytic leukaemia (CLL). All treatments were of fixed duration. Following a
five-week dose ramp-up schedule for Venclexta/Venclyxto, patients on the
Venclexta/Venclyxto plus MabThera/Rituxan arm received six cycles of
Venclexta/Venclyxto plus MabThera/Rituxan followed by Venclexta/Venclyxto
monotherapy for up to two years total. Patients on the BR arm received six
cycles of BR. The study included 389 patients with CLL who had been previously
treated with at least one line of therapy. Patients were randomly assigned in a
1:1 ratio to receive either Venclexta/Venclyxto plus MabThera/Rituxan or BR. The
primary endpoint of the study was progression-free survival (PFS). Secondary
endpoints included overall survival, overall response rate and complete response
rate (with or without complete blood count recovery).

About the M14-358 study
The M14-358 study (NCT02203773) is an open-label, non-randomised, phase Ib dose
escalation and expansion study evaluating the safety and efficacy of
Venclexta/Venclyxto in combination with hypomethylating agents, azacitidine or
decitabine, in 115 newly-diagnosed people with acute myeloid leukaemia who were
60 years or older, or ineligible to receive intensive induction chemotherapy due
to coexisting medical conditions. Study endpoints included complete remission
rates, transfusion independence, overall survival and safety.

About the M14-387 study
The M14-387 study (NCT02287233) is an open-label, single-arm, phase I/II dose
escalation and expansion study evaluating the safety and efficacy of
Venclexta/Venclyxto in combination with low-dose cytarabine (LDAC) in 82 newly-
diagnosed people with acute myeloid leukaemia who were 60 years or older, or
ineligible to receive intensive induction chemotherapy due to coexisting medical
conditions. Study endpoints included complete remission rates, transfusion
independence, overall survival and safety.

About Venclexta/Venclyxto
Venclexta/Venclyxto is a first-in-class targeted medicine designed to
selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some
blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from
dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto
blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly
commercialised by AbbVie and Genentech, a member of the Roche Group, in the
United States, and commercialised by AbbVie outside of the United States.
Together, the companies are committed to research with Venclexta/Venclyxto,
which is currently being studied in clinical trials across several types of
blood and other cancers.

In the US, Venclexta has been granted four Breakthrough Therapy Designations by
the FDA: in combination with Rituxan for people with relapsed or refractory
chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed
or refractory CLL with 17p deletion; in combination with hypomethylating agents
(azacitidine or decitabine) for people with untreated acute myeloid leukaemia
(AML) ineligible for intensive chemotherapy; and in combination with low-dose
cytarabine for people with untreated AML ineligible for intensive chemotherapy.

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the
Western world.[1] CLL mainly affects men and the median age at diagnosis is
about 70 years. [2] Worldwide, the incidence of all leukaemias is estimated to
be more than 400,000 [3] and CLL is estimated to affect around one-third of all
people newly diagnosed with leukaemia. [1]

About Acute Myeloid Leukaemia
Acute myeloid leukaemia (AML) is an aggressive form of leukaemia that starts in
immature forms of blood-forming cells, known as myeloid cells, found in the bone
marrow. [4] AML is the most common type of aggressive leukaemia in adults. It
has the lowest survival rates of all types of leukaemia. [5] Even with the best
available therapies, older patients aged 65 and over have survival rates
comparable to patients with advanced lung cancer, with a five year overall
survival rate of <5%.[6;7] Approximately 20,000 people in the US and 18,000 in
Europe are diagnosed with AML each year. [8;9]

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®/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] Wendtner CM, et al. Chronic lymphocytic leukemia. Onkopedia guidelines 2012
[Internet; cited 2018]. Available from: https://www.onkopedia-
guidelines.info/en/onkopedia/guidelines/chronic-lymphocytic-leukemia-
cll/@@view/html/index.html
[2] SEER Stat Fact Sheets: Chronic Lymphocytic Leukemia (CLL) [Internet; cited
2018]. Available from: http://seer.cancer.gov/statfacts/html/clyl.html.
[3] GLOBOCAN 2018. World Fact Sheet. [Internet; accessed 2018]. Available from:
http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
[4] American Cancer Society: What is acute myeloid leukemia? [Internet; cited
2018]. Available from: https://www.cancer.org/cancer/acute-myeloid-
leukemia/about/what-is-aml.html
[5] Leukemia & Lymphoma Society: Facts and statistics overview - Leukemia.
[Internet; cited 2018]. Available from:
http://www.lls.org/http%3A/llsorg.prod.acquia-sites.com/facts-and-
statistics/facts-and-statistics-overview/facts-and-statistics#Leukemia.
[6] Sekeres MA. Treatment Of Older Adults With Acute Myeloid Leukemia: State Of
The Art And Current Perspectives. Haematologica 2008;93:1769-1772
[7] Cancer Research UK: Survival statistics for acute myeloid leukaemia (AML).
[Internet; cited 2018]. Available from: http://www.cancerresearchuk.org/about-
cancer/acute-myeloid-leukaemia-
aml/survival?_ga=2.239561667.1384102361.1500450925-993068745.1500450925
[8] National Cancer Institute. Adult Acute Myeloid Leukemia Treatment (PDQ®)-
Health Professional Version [Internet; cited 2018 May]. Available from:
https://www.cancer.gov/types/leukemia/hp/adult-aml-treatment-pdq.
[9] Visser O, et al. (RARECARE Working Group). Incidence, survival and
prevalence of myeloid malignancies in Europe. Eur J Cancer. 2012;48:3257-3266.


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_Venclexta_EN:
http://hugin.info/174806/R/2227619/874569.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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