Obinutuzumab (GA101) Significantly Improved Progression-Free Survival in
People With Chronic Lymphocytic Leukemia (CLL)
--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. -- January 31, 2013
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 armsin 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
About Obinutuzumab (GA101)
GA101 is Genentech’s most advanced investigational medicine in development
forhematologicalmalignancies (cancers which affect the blood, bone marrow
and lymph nodes). GA101 targets CD20 proteins found on B-cells, and is
designed to result incell 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.
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.
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
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
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.
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
Joe St. Martin, 650-467-6800
Jen Mills, 650-467-6722
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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