Obinutuzumab (GA101) Significantly Improved Progression-Free Survival in People With Chronic Lymphocytic Leukemia (CLL)

Thu Jan 31, 2013 1:01am EST

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--The First Stage of This Phase III Study Met Its Primary Endpoint and an
Additional Futility Analysis Suggested That GA101 Could Show Superiority
Compared to Rituxan in First-Line CLL--
SOUTH SAN FRANCISCO, Calif.--(Business Wire)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced positive results from Stage 1 of CLL11, a Phase III randomized study
to investigate the efficacy and safety profile of the investigational medicine
obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil
alone in people with previously untreated chronic lymphocytic leukemia (CLL). An
improvement in progression-free survival (PFS) was achieved as GA101 plus
chlorambucil significantly reduced the risk of disease worsening or death
compared to chlorambucil alone. 

"The improvement in progression-free survival seen with GA101 is encouraging for
people with CLL, a chronic illness of older people for which new treatment
options are needed," said Hal Barron, M.D., chief medical officer and head,
Global Product Development. "GA101 demonstrates our ongoing commitment to the
research and development of new medicines for this disease." 

GA101 has been specifically designed as the first glycoengineered, type 2
anti-CD20 monoclonal antibody in development for B-cell malignancies. In
pre-clinical development, GA101 has shown evidence of increased direct cell
killing and antibody-dependent cellular cytotoxicity (ADCC). As a result,
GA101`s clinical development program is designed to assess whether or not it is
superior to Rituxan® (rituximab) in CLL and non-Hodgkin`s lymphoma (NHL). 

CLL11 is a three-arm study that compares GA101 plus chlorambucil to Rituxan plus
chlorambucil or chlorambucil alone. The study includes two separate stages.
Stage 1 evaluated GA101 plus chlorambucil to chlormabucil alone, and included a
pre-planned PFS futility analysis comparing GA101 plus chlorambucil to Rituxan
plus chlorambucil. The goal of this futility analysis was to evaluate the
likelihood that the study would meet its pre-specified endpoint criteria during
Stage 2 analysis - improved efficacy (PFS) in the direct comparison of GA101
plus chlorambucil to Rituxan plus chlorambucil. The independent Data and Safety
Monitoring Board (DSMB) assessment concluded that Stage 2 of the study should
continue until its final analysis. No new safety events were reported for the
GA101 or Rituxan containing arms in the study up to the time of this analysis. 

Data from CLL11 will be submitted for presentation at an upcoming medical
meeting and submitted to European regulatory authorities and the U.S. Food and
Drug Administration (FDA) for potential approval. 

About CLL11 (BO21004)

CLL11 is a Phase III, multicenter, open-label, randomized three-arm study
investigating the safety and efficacy profile of GA101 plus chlorambucil
compared to Rituxan plus chlorambucil or chlorambucil alone in nearly 800
previously untreated people with CLL and coexisting medical conditions. The
study is conducted in close collaboration with the German CLL Study Group
(DCLLSG). The primary endpoint of the study is PFS with secondary endpoints
including overall response rate (ORR), overall survival (OS), disease free
survival (DFS), molecular remission and safety profile. 

About Hematological Malignancies

Hematological malignancies are cancers of the blood and include CLL, indolent
NHL and diffuse large B-cell lymphoma (DLBCL). In 2013, it is expected that
there will be nearly 19,020 annual deaths from NHL and nearly 4,580 annual
deaths from CLL in the United States. 

The current standard of care in CD20-positive hematological malignancies is
Rituxan in combination with chemotherapy or as a single agent. 

In addition to GA101, our pipeline of potential hematology medicines includes
two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a
small molecule BCL-2 inhibitor (RG7601) and a small molecule antagonist of MDM2
(RG7112). 

About Obinutuzumab (GA101)

GA101 is Genentech`s most advanced investigational medicine in development for
hematological malignancies (cancers which affect the blood, bone marrow and
lymph nodes). GA101 targets CD20 proteins found on B-cells, and is designed to
result in cell death. 

GA101 is the first glycoengineered, type 2 anti-CD20 monoclonal antibody in
development for B-cell malignancies. GA101 is currently being investigated in
multiple clinical trials, including head-to-head trials versus Rituxan. 

About Rituxan

Rituxan is a therapeutic antibody that binds to a specific protein called CD20
found on the surface of cancerous and normal B-cells. In CLL, NHL and rheumatoid
arthritis (RA), Rituxan works with the body's own immune system to eliminate
marked CD20-positive B-cells. Stem cells (those cells that give rise to B-cells)
in bone marrow do not have the CD20 protein. B-cells usually regenerate after
Rituxan treatment and return to normal levels in about 12 months for most
patients. 

Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997
for the treatment of relapsed or refractory, low-grade or follicular,
CD20-positive, B-cell NHL as a single agent. It was approved in the European
Union under the trade name MabThera in June 1998. 

INDICATIONS

Rituxan® (Rituximab) is indicated for the treatment of patients with:

* Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as
a single agent 
* Previously untreated follicular, CD20-positive, B-cell NHL in combination with
first-line chemotherapy and, in patients achieving a complete or partial
response to Rituxan in combination with chemotherapy, as single-agent
maintenance therapy 
* Non-progressing (including stable disease), low-grade, CD20-positive, B-cell
NHL, as a single agent, after first-line CVP chemotherapy 
* Previously untreated diffuse large B-cell, CD20-positive NHL in combination
with CHOP or other anthracycline-based chemotherapy regimens 
* Previously untreated and previously treated CD20-positive CLL in combination
with fludarabine and cyclophosphamide (FC)

Rituxan is not recommended for use in patients with severe, active infections.

Important Safety Information:

Rituxan can cause serious side effects that can lead to death, including:
infusion reactions, tumor lysis syndrome (kidney failure due to fast breakdown
of cancer cells), severe skin and mouth reactions, and progressive multifocal
leukoencephalopathy (a rare, serious brain infection). 

Rituxan has also been associated with serious and life-threatening side effects,
including: the return of active hepatitis B virus infection with sudden and
serious liver problems including liver failure, and death, other serious
infections that can lead to death, heart problems, kidney problems, and stomach
and serious bowel problems including blockage and tears in the bowel, that can
sometimes lead to death. 

The most common side effects of Rituxan seen in patients with NHL were infusion
reactions, fever, chills, low white blood cells, infections, body aches, and
tiredness. The most common side effects of Rituxan in patients with CLL were
infusion reactions and low white blood cells. Patients should talk to their
doctor about their medical history before starting treatment with Rituxan. 

Patients should tell their doctor about any side effect that bothers them or
that does not go away. These are not all of the possible side effects with
Rituxan. 

Report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch.Patients and caregivers may also report side effects
to Genentech at (888) 835-2555.

Patients should read the Rituxan Full Prescribing Information including Boxed
WARNINGS, and the Medication Guide at http://www.rituxan.com. 

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit http://www.gene.com.

Genentech
Media Contact:
Joe St. Martin, 650-467-6800
Advocacy Contact:
Jen Mills, 650-467-6722
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503 



Copyright Business Wire 2013

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