-
First Phase III study to show superior progression-free survival
compared to Rituxan-based standard of care treatment for most common
slow-growing form of non-Hodgkin’s lymphoma
-
Results will be presented during the Plenary Scientific Session at
58th American Society of Hematology Annual Meeting
Company Website:
http://www.gene.com
SOUTH SAN FRANCISCO, Calif. -- (Business Wire)
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced data from the positive, pivotal Phase III GALLIUM study
that compared Gazyva® (obinutuzumab) plus chemotherapy
followed by Gazyva alone head-to-head against Rituxan®
(rituximab) plus chemotherapy followed by Rituxan alone for people with
previously untreated follicular lymphoma. At a pre-planned interim
analysis in May 2016, an independent data monitoring committee
determined that the study met its primary endpoint early. The results
showed Gazyva-based treatment reduced the risk of disease worsening or
death (progression-free survival; PFS, as assessed by investigator) by
34 percent compared to Rituxan-based treatment (HR=0.66; 95% CI
0.51-0.85, p=0.0012). Median PFS was not yet reached. Adverse events
with either Gazyva or Rituxan were consistent with those seen in
previous studies.
“Follicular lymphoma, the most common slow-growing form of non-Hodgkin’s
lymphoma, is an incurable blood cancer characterized by cycles of
remission and disease progression, and becomes harder to treat with
every relapse,” said Sandra Horning, M.D., chief medical officer and
head of Global Product Development. “This study of Gazyva-based
treatment is the first and only Phase III trial to date to show superior
progression-free survival compared to Rituxan-based treatment, the
current standard of care, in previously untreated follicular lymphoma.”
The primary results from the GALLIUM study (Abstract #6) will be
presented during the Plenary Scientific Session of the 58th American
Society of Hematology (ASH) Annual Meeting in San Diego by Dr. Robert
Marcus, King’s College Hospital, London and the National Cancer Research
Institute (NCRI), on Sunday, December 4 at 2:00 P.M. PST. Additionally,
an analysis of minimal residual disease (MRD) status in the GALLIUM
study (Abstract #613) will be presented in a separate oral session by
Dr. Christiane Pott, University Hospital Schleswig-Holstein, Kiel,
Germany, and the German Low Grade Lymphoma Study Group (GLSG) on Monday,
December 5 at 7:00 A.M. PST.
GALLIUM is the third positive Phase III study for Gazyva, following the
CLL11 study in patients with previously untreated chronic lymphocytic
leukemia (CLL) and the GADOLIN study in patients with indolent
(slow-growing) non-Hodgkin’s lymphoma whose disease progressed during or
within six months of prior Rituxan-based therapy. The results of the
GALLIUM study will be submitted to health authorities around the world
for approval consideration.
About the GALLIUM study
GALLIUM (NCT01332968) is a global Phase III open-label, multicenter,
randomized two-arm study examining the efficacy and safety of Gazyva
plus chemotherapy followed by Gazyva alone for up to two years, as
compared head-to-head against Rituxan plus chemotherapy followed by
Rituxan alone for up to two years. Chemotherapies used were CHOP, CVP or
bendamustine and were selected by each participating study site prior to
beginning enrollment. GALLIUM included 1401 patients with previously
untreated indolent non-Hodgkin’s lymphoma (iNHL), of which 1202 patients
had follicular lymphoma. The primary endpoint of the study was
investigator-assessed PFS in patients with follicular lymphoma, with
secondary endpoints including PFS assessed by independent review
committee (IRC), PFS in the overall study population (iNHL), response
rate (overall response, ORR; and complete response, CR), overall
survival (OS) and safety. The GALLIUM study is being conducted in
cooperation with the GLSG (Germany), the East German Study Group
Hematology and Oncology (OSHO; Germany) and the NCRI (United Kingdom).
A summary of the GALLIUM study results presented at ASH is included
below.
Study Group |
|
Patients with previously untreated follicular lymphoma
|
Treatment Group |
|
Gazyva + chemotherapy, followed by Gazyva alone
|
|
Rituxan + chemotherapy, followed by Rituxan alone
|
N= |
|
601
|
|
601
|
PFS(primary and secondary endpoints)1 |
PFS |
|
Investigator: HR=0.66 (0.51, 0.85), p=0.0012
Independent: HR=0.71 (0.54, 0.93), p=0.0138
|
PFS Rate at 3 Years |
|
Investigator: 80.0% Independent: 81.9%
|
|
Investigator: 73.3% Independent: 77.9%
|
OS (secondary endpoint)
|
OS |
|
HR=0.75 (0.49, 1.17), p=0.21
|
OS Rate at 3 Years |
|
94.0%
|
|
92.1%
|
Time to Next Treatment (TTNT; secondary endpoint)
|
TTNT |
|
HR=0.68 (0.51, 0.91), p=0.0094
|
TTNT at 3 Years |
|
87.1%
|
|
81.2%
|
Response Rates (at end of induction; secondary endpoints)2 |
ORR |
|
88.5%
|
|
86.9%
|
CR |
|
19.5%
|
|
23.8%
|
Partial Response (PR) |
|
69.1%
|
|
63.1%
|
Minimal Residual Disease (MRD; exploratory endpoint) [Pott
et al.] |
N= |
|
351
|
|
345
|
MRD-Negativity3(in blood and/or
bone marrow at end of treatment with Gazyva or Rituxan plus
chemotherapy)
|
|
92.0%
|
|
84.9%
|
|
p=0.0041
|
Safety (secondary endpoint)
|
N= |
|
595
|
|
597
|
Adverse Events (AEs) |
| -
AEs observed with Gazyva and Rituxan were consistent with those
seen in previous clinical trials when each was combined with
various chemotherapies.
-
The overall rate of Grade 3 or higher AEs occurring in the
Gazyva and Rituxan arms was 74.6% and 67.8%, respectively.
-
The most common Grade 3 or higher AEs that occurred more often
in the Gazyva versus Rituxan arm were low white blood cell
counts (neutropenia, 43.9% vs. 37.9%; leukopenia, 8.6% vs.
8.4%), low white blood cell count with fever (febrile
neutropenia, 6.9% vs. 4.9%), infusion-related reactions4
(12.4% vs. 6.7%), low platelet count (thrombocytopenia, 6.1% vs.
2.7%), infections (20.0% vs. 15.6%) and second neoplasms (4.7%
vs. 2.7%).
-
Fatal AEs occurred in 4.0% of people in the Gazyva arm compared
to 3.4% of people in the Rituxan arm.
|
1 Primary endpoint is PFS as assessed by investigator; median
follow-up of 34.5 months
2 Measured by computerized
tomography (CT) scans
3 MRD-negativity means no cancer
can be detected in the blood or bone marrow using a specific highly
sensitive test
4 Defined as any AE occurring during or
within 24 hours of infusion of Gazyva or Rituxan and considered
drug-related
About Follicular Lymphoma
Follicular lymphoma is the most common indolent (slow-growing) form of
non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of
NHL. It is considered incurable and relapse is common. In the United
States, it is estimated that more than 14,000 new cases of follicular
lymphoma will be diagnosed in 2016.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach to CD20,
a protein found on certain types of B-cells. It is thought to work by
attacking targeted cells both directly and together with the body's
immune system. Gazyva was discovered by Roche Glycart AG, a wholly
owned, independent research unit of Roche. In the United States, Gazyva
is part of a collaboration between Genentech and Biogen.
Combination studies investigating Gazyva with other approved or
investigational medicines, including cancer immunotherapies and small
molecule inhibitors, are planned or underway across a range of blood
cancers.
Gazyva U.S. Indications
Gazyva® (obinutuzumab) is a prescription medicine used:
-
With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic
leukemia (CLL) in adults who have not had previous CLL treatment.
-
With the chemotherapy drug, bendamustine, followed by Gazyva alone for
follicular lymphoma (FL) in adults who did not respond to a
rituximab-containing regimen, or whose FL returned after such
treatment.
Important Safety Information
Patients must tell their doctor right away about any side effects
they experience. Gazyva can cause side effects that can become serious
or life threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and
death. If a patient has had history of hepatitis B infection, Gazyva
could cause it to return. Patients should not receive Gazyva if they
have active hepatitis B liver disease. The patient’s doctor or
healthcare team will need to screen for hepatitis B before, and monitor
the patient for hepatitis during and after, treatment with Gazyva.
Sometimes this will require treatment for hepatitis B. Symptoms of
hepatitis include: worsening of fatigue and yellow discoloration of skin
or eyes.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare
and serious brain infection caused by a virus. PML can be fatal. A
patient’s weakened immune system could put the patient at risk. The
patient’s doctor will watch for symptoms. Symptoms of PML include:
confusion, difficulty talking or walking, dizziness or loss of balance,
and vision problems.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effects they
experience. Gazyva can cause side effects that may become severe or life
threatening, including:
- Infusion Reactions: These side effects may occur during or
within 24 hours of any Gazyva infusion. Some infusion reactions can be
serious, including, but not limited to, severe allergic reactions
(anaphylaxis), acute life-threatening breathing problems, or other
life-threatening infusion reactions. If a patient has a reaction, the
infusion is either slowed or stopped until the patient’s symptoms are
resolved. Most patients are able to complete infusions and receive
medication again. However, if the infusion reaction is serious, the
infusion of Gazyva will be permanently stopped. The patient’s
healthcare team will take steps to help lessen any side effects the
patient may have to the infusion process. The patient may be given
medicines to take before each Gazyva treatment. Signs of infusion
reactions may include: tiredness, dizziness, headache, redness of the
face, nausea, chills, fever, vomiting, diarrhea, breathing problems,
and chest pain
- Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including
fatal cases, has been reported in patients receiving Gazyva. Gazyva
works to break down cancer cells quickly. As cancer cells break apart,
their contents are released into the blood. These contents may cause
damage to organs and the heart, and may lead to kidney failure
requiring the need for dialysis treatment. The patient’s doctor may
prescribe medication to help prevent TLS. The patient’s doctor will
also conduct regular blood tests to check for TLS. Symptoms of TLS may
include nausea, vomiting, diarrhea, and tiredness
- Infections: While a patient is taking Gazyva, the patient may
develop infections. Some of these infections may be severe. Fatal
infections have been reported, so the patient should be sure to talk
to the doctor if the patient thinks the patient has one. Patients with
active infection should not be treated with Gazyva. The patient’s risk
for infections may continue even after the patient stops taking
Gazyva. The patient’s doctor may prescribe medications to help prevent
infections. Symptoms of infection include fever and cough
- Low White Blood Cell Count: When a patient has an abnormally
low count of infection-fighting white blood cells, it is called
neutropenia. While the patient is taking Gazyva, the patient’s doctor
will do blood work to check the patient’s white blood cell counts.
Severe and life-threatening neutropenia can develop during or after
treatment with Gazyva. Some cases of neutropenia can last for more
than one month. If a patient’s white blood cell count is low, the
patient’s doctor may prescribe medication to help prevent infections
- Low Platelet Count: Platelets help stop bleeding or blood loss.
Gazyva may reduce the number of platelets the patient has in the
blood; having low platelet count is called thrombocytopenia. This may
affect the clotting process. While the patient is taking Gazyva, the
patient’s doctor will do blood work to check the patient’s platelet
count. Severe and life-threatening thrombocytopenia can develop during
or after treatment with Gazyva. If the patient’s platelet count gets
too low, the treatment may be delayed or reduced
Most common side effects of Gazyva
The most common side effects of Gazyva in CLL are infusion reactions,
low white blood cell counts, low platelet counts, low red blood cell
counts, fever, cough, nausea, and diarrhea.
The safety of Gazyva was evaluated based on 392 patients with indolent
NHL (iNHL) of whom 81 percent had follicular lymphoma. In patients with
follicular lymphoma, the most common side effects that were seen were
consistent with the overall population who had iNHL.
The most common side effects of Gazyva are infusion reactions, low white
blood cell counts, nausea, fatigue, cough, diarrhea, constipation,
fever, low platelet counts, vomiting, upper respiratory tract infection,
decreased appetite, joint or muscle pain, sinusitis, low red blood cell
counts, general weakness, and urinary tract infection.
Before receiving Gazyva, patients should talk to their doctor about:
Immunizations: Before receiving Gazyva therapy, the patient
should tell the patient’s healthcare provider if the patient has
recently received or is scheduled to receive a vaccine. Patients who are
treated with Gazyva should not receive live vaccines.
Pregnancy: A patient should tell the doctor if the patient is
pregnant, plans to become pregnant, or is breastfeeding. Gazyva may harm
the unborn baby. Mothers who have been exposed to Gazyva during
pregnancy should discuss the safety and timing of live virus
vaccinations for their infants with their child’s healthcare providers.
It is not known if Gazyva may pass into the patient’s breast milk. The
patient should speak to the doctor about using Gazyva if the patient is
breastfeeding.
Patients must tell their doctor about any side effects.
These are not all of the possible side effects of Gazyva. For more
information, patients should ask their doctor or pharmacist.
Gazyva is available by prescription only.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
Please visit http://www.Gazyva.com
for the Gazyva full Prescribing Information, including Boxed WARNINGS,
for additional Important Safety Information.
Rituxan Indications
Rituxan® (rituximab) is indicated for the treatment of
patients with:
-
Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a
single-agent therapy in patients whose disease recurred or did not
respond to initial treatment
-
Follicular CD20-positive non-Hodgkin’s lymphoma as an initial
treatment with chemotherapy, and in patients whose initial treatment
was successful, as a single-agent follow-up therapy
-
Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent
follow-up therapy for patients who did not progress on initial
treatment with CVP chemotherapy
-
CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an
initial treatment in combination with CHOP chemotherapy
-
CD20-positive chronic lymphocytic leukemia in combination with FC
chemotherapy as an initial treatment or as a treatment after disease
has recurred
People with serious infections should not receive Rituxan.
It is not known if Rituxan is safe or effective in children.
Important Safety Information:
Patients must tell their doctor right away about any side effects they
experience. Rituxan can cause serious side effects that can lead to
death, including:
- Infusion Reactions: may occur during or within 24 hours of the
infusion. The patient’s doctor should give the patient medicines
before their treatment. Symptoms can include hives, rash, itching,
facial or oral swelling, sudden cough, shortness of breath, difficulty
breathing, weakness, dizziness, feeling faint, racing heart or chest
pain.
- Severe Skin and Mouth Reactions: symptoms can include painful
sores, ulcers, or blisters on the skin, lips or mouth; peeling skin;
rash; or pustules.
- Hepatitis B Virus (HBV) Reactivation: may cause serious liver
problems including liver failure and death. If patients have had
hepatitis B or are carriers of HBV, receiving Rituxan could cause the
virus to become an active infection again. Patients should not receive
Rituxan if they have active HBV liver disease. The patient’s doctor
will do blood tests to check for HBV infection prior to treatment and
will monitor the patient during and for several months following their
treatment.
- Progressive Multifocal Leukoencephalopathy (PML): a rare,
serious brain infection that can lead to severe disability and death
and for which there is no known prevention, treatment or cure.
Symptoms can include difficulty thinking, loss of balance, changes in
speech or walking, weakness on one side of the body or blurred or lost
vision.
What are the additional possible serious side effects of Rituxan?
Patients must tell their doctor right away about any side effects they
experience. Rituxan can cause serious side effects that can lead to
death, including:
- Tumor Lysis Syndrome (TLS): may cause kidney failure and the
need for dialysis treatment, abnormal heart rhythm and can lead to
death. The patient’s doctor may give the patient medicines before
their treatment to help prevent TLS.
- Serious Infections: can happen during and after treatment and
can lead to death. These infections may be bacterial, fungal or viral.
Symptoms can include fever; cold or flu symptoms; earache or headache;
pain during urination; white patches in the mouth or throat; cuts or
scrapes that are red, warm, swollen or painful.
- Heart Problems: symptoms can include chest pain and irregular
heartbeats that may require treatment. The patient’s doctor may need
to stop their treatment.
- Kidney Problems: the patient’s doctor should do blood tests to
check how well the patient’s kidneys are working.
- Stomach and Serious Bowel Problems: can include blockage or
tears in the bowel that can lead to death. Stomach area pain during
treatment can be a symptom.
- Low Blood Cell Counts: the patient’s blood cell counts may be
monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills,
infections, body aches, tiredness and low white blood cells.
Patients must tell their doctor if they are pregnant, plan to become
pregnant or are breastfeeding. It is not known if Rituxan may harm the
patient’s unborn baby or pass into the patient’s breast milk. Women
should use birth control while using Rituxan and for 12 months after
treatment.
Patients must 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 of Rituxan. For more
information, patients should ask their doctor or pharmacist.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.Report side effects to Genentech at (888) 835-2555.
Please visit http://www.Rituxan.com
for the Rituxan full Prescribing Information, including Boxed WARNINGS
and Medication Guide, for additional Important Safety Information.
About Genentech In Hematology
For more than 20 years, Genentech has been developing medicines with the
goal to redefine treatment in hematology. Today, we’re investing more
than ever in our effort to bring innovative treatment options to people
with diseases of the blood. In addition to approved medicines,
Genentech’s pipeline of investigational hematology medicines includes an
anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a
small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech’s
dedication to developing novel medicines for blood diseases expands
beyond oncology, with the development of the investigational hemophilia
A treatment emicizumab (ACE910). For more information visit http://www.gene.com/hematology.
About Genentech
Founded 40 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161204005042/en/
Contacts:
Genentech
Media Contact:
Stephanie Huang, 650-467-6800
Advocacy
Contact:
Angela Wilson, 202-423-2739
Investor Contacts:
Neera
Dahiya Ravindran, M.D., 650-491-5281
Karl Mahler, 011 41 61 687 8503
Source: Genentech
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