– Study results across 17 medicines reflect our commitment to
personalized care with advances in targeted therapies, immunotherapy,
and diagnostics, data and analytics –
– New pivotal data on fixed-duration combination of Venclexta plus
Gazyva in previously untreated chronic lymphocytic leukemia –
– New data for entrectinib in pediatric patients with recurrent or
refractory solid tumors harboring NTRK, ROS1 or ALK gene fusions –
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that new data from clinical trials of 17 approved and
investigational medicines across 27 cancer types, including
hard-to-treat and rare tumors, will be presented at the 2019 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May
31-June 4, 2019. A total of 155 abstracts that include a Genentech
medicine will be presented at this year’s meeting.
“At this year’s ASCO meeting, we are excited to present new data with
targeted therapies, immunotherapy and pipeline combinations across a
broad range of diseases including blood, breast and lung cancers, as
well as pediatric tumors treated with our personalized cancer medicine,
entrectinib,” said Sandra Horning, M.D., chief medical officer and head
of Global Product Development. “Through pioneering science, strategic
partnerships and data and analytics, we’re striving to develop
transformative medicines that can help improve outcomes for each
individual patient.”
For more resources, information and unique perspectives from scientists,
researchers and physicians on key industry topics, visit http://www.gene.com/asco.
Keep up to date on ASCO meeting news and updates by following Genentech
on Twitter via @genentech and using the hashtag #ASCO19.
Key presentations in blood cancers
The first data from the pivotal Phase III CLL14 study will be presented
at ASCO, evaluating the 12-month, fixed-duration, chemotherapy-free
combination of Venclexta® (venetoclax) plus Gazyva®
(obinutuzumab) compared to Gazyva plus chlorambucil in people with
previously untreated chronic lymphocytic leukemia (CLL) and co-existing
medical conditions. The CLL14 study is being conducted in cooperation
with the German CLL Study Group (GCLLSG), headed by Michael Hallek,
M.D., University of Cologne.
The U.S. Food and Drug Administration (FDA) is reviewing a supplemental
New Drug Application (sNDA) based on results of the CLL14 study under
the FDA’s Real-Time Oncology Review and Assessment Aid pilot programs.
Venclexta is being developed by AbbVie and Genentech, a member of the
Roche Group.
Key presentations in pediatric cancers
The first data from the Phase I/II STARTRK-NG study of the
investigational medicine entrectinib in children and adolescents with
recurrent or refractory solid tumors harboring neurotrophic tyrosine
receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase
(ALK)-positive tumors, including central nervous system tumors, will be
presented. The study enrolled children and adolescents ages 4.9 months
through 20 years (median age of seven years) across several different
cancer types, including some rare tumors. The STARTRK-NG data will be
featured as part of ASCO’s official press program on Wednesday, May 15.
The FDA recently granted Priority Review for entrectinib for the
treatment of pediatric and adult patients with NTRK fusion-positive,
locally advanced or metastatic solid tumors who have either progressed
following prior therapies or as initial therapy when there are no
acceptable standard therapies, and for the treatment of people with
metastatic, ROS1-positive non-small cell lung cancer (NSCLC). These NDAs
are based on results from the integrated analysis of the pivotal Phase
II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and
data from the STARTRK-NG study. The FDA is expected to make a decision
on the approval by August 18, 2019.
Key presentations in breast cancers
Key data to be presented at ASCO include updates from Genentech’s breast
cancer program across multiple subtypes of the disease, including the
second interim analysis of overall survival (OS) results, updated safety
data and patient-reported outcomes (PROs) from the Phase III
IMpassion130 study of Tecentriq® (atezolizumab) plus
chemotherapy (Abraxane® [paclitaxel protein-bound particles
for injectable suspension (albumin-bound); nab-paclitaxel]) for
the treatment of PD-L1-positive, metastatic triple-negative breast
cancer (TNBC). This combination was recently granted accelerated
approval from the FDA based on progression-free survival (PFS) for the
treatment of adults with unresectable locally advanced or metastatic
TNBC in people whose tumors express PD-L1, as determined by an
FDA-approved test.
Additional data include an eight-year, end-of-study analysis from the
Phase III CLEOPATRA study of Perjeta® (pertuzumab) plus
Herceptin® (trastuzumab) and chemotherapy for first-line
treatment of HER2-positive metastatic breast cancer.
Key presentations in lung cancers
Key data from Genentech’s broad lung cancer program will be presented
across different types of the disease, including results from the Phase
III IMpower150 trial of Tecentriq plus Avastin® (bevacizumab)
and chemotherapy (carboplatin and paclitaxel) in chemotherapy-naïve
people previously untreated for metastatic NSCLC whose cancer has spread
to the liver, which affects approximately 20% of people with the
disease. Additionally, results from studies in partnership with Flatiron
Health will be presented, including validation of the use of
next-generation sequencing data on a broad scale to improve the
understanding of clinical outcomes in people with metastatic lung
cancer, and results that illustrate how real-world data can be used to
supplement evidence from clinical trials in rare tumor types such as
ROS1-positive lung cancer.
|
Key presentations featuring Genentech medicines at ASCO 2019 |
||||
| Medicine | Abstract title | Abstract number | ||
| Blood cancer | ||||
|
Venclexta
(venetoclax)
Gazyva (obinutuzumab) |
Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on |
Abstract 7502 |
||
| Venclexta |
Safety and activity of venetoclax in combination with high-dose cytarabine in children with relapsed or refractory acute myeloid leukemia |
Abstract 10004 |
||
| polatuzumab vedotin |
Polatuzumab vedotin (Pola) + obinutuzumab (G) and lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) follicular lymphoma (FL): Interim analysis of a Phase Ib/II trial |
Abstract 7505 |
||
| Tumor agnostic | ||||
| entrectinib |
Phase I/II trial to assess the activity of entrectinib in children and adolescents with recurrent or refractory solid tumors including central nervous system (CNS) tumors |
Abstract 10009 |
||
| entrectinib |
Efficacy of entrectinib in patients (pts) with solid tumors and central nervous system (CNS) metastases: Integrated analysis from three clinical trials |
Abstract 3017 |
||
| Breast cancer | ||||
|
Tecentriq
(atezolizumab) |
IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC) |
Abstract 1003 |
||
|
Perjeta
(pertuzumab)
Kadcyla (ado- trastuzumab emtansine)
Herceptin (trastuzumab) |
Neoadjuvant trastuzumab (H), pertuzumab (P), and chemotherapy versus trastuzumab emtansine (T-DM1) and P in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC): Final outcome results from the Phase III KRISTINE study |
Abstract 500 |
||
|
Perjeta
Herceptin |
Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial |
Abstract 1012 |
||
|
Perjeta
Herceptin |
End-of-study analysis from the phase III, randomized, double-blind, placebo (Pla)-controlled CLEOPATRA study of first-line (1L) pertuzumab (P), trastuzumab (H), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC) |
Abstract 1020 |
||
| Tecentriq |
IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC) |
Abstract 1068 |
||
| Tecentriq |
Patient-reported outcomes (PROs) from the Phase III IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC) |
Abstract 1067 |
||
|
Kadcyla
Herceptin |
Patient-reported outcomes (PROs) from KATHERINE: A Phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients (pts) with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer |
Abstract 513 |
||
|
Perjeta
Herceptin |
A phase III, randomized, double-blind, placebo (Pla)-controlled study of pertuzumab (P) + trastuzumab (H) + docetaxel (D) versus Pla + H+ D in previously untreated HER2-positive locally recurrent/metastatic breast cancer (LR/MBC) (PUFFIN). |
Abstract 1026 |
||
| Lung cancer | ||||
| Tecentriq |
IMpower150: Analysis of efficacy in patients (pts) with liver metastases (mets) |
Abstract 9012 (poster discussion) Sunday, June 2
4:30 – 6:00 PM |
||
| Tecentriq |
Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Interim analysis and biomarker data from a multicenter study (LCMC3) |
Abstract 8503 (oral)
Saturday, June 1 |
||
| entrectinib |
Time-to-treatment discontinuation (TTD) and real-world progression-free survival (rwPFS) as endpoints for comparative efficacy analysis between entrectinib trial and crizotinib real-world ROS1 fusion-positive (ROS1+) NSCLC patients |
Abstract 9070 (poster) Sunday, June 2
8:00 – 11:00 AM |
||
| Alecensa (alectinib) |
Final PFS analysis and safety data from the phase III J-ALEX study of Alectinib(ALC) vs. Crizotinib(CRZ) in ALK-inhibitor naïve ALK-positive Non-Small Cell Lung Cancer (ALK+NSCLC) |
Abstract 8569 (poster)
Sunday, June 2 |
||
| Genitourinary cancers | ||||
| Tecentriq |
Clinical outcomes according to PD-L1 status and age in the prospective international SAUL study of atezolizumab (atezo) for locally advanced or metastatic urothelial carcinoma (UC) or non-UC of the urinary tract |
Abstract 4519
1:15 – 4:15 PM |
||
About Venclexta
Venclexta 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 tumors, BCL-2 builds up and prevents cancer cells from
dying or self-destructing, a process called apoptosis. Venclexta blocks
the BCL-2 protein and works to restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the
Roche Group. It is jointly commercialized by the companies in the United
States and commercialized by AbbVie outside of the United States.
Together, the companies are committed to research with Venclexta, which
is currently being studied in clinical trials across several types of
blood and other cancers.
Venclexta Indications
Venclexta is a prescription medicine used:
-
To treat adults with chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL), with or without 17p deletion, who have
received at least 1 prior treatment. -
In combination with azacitidine, or decitabine, or low-dose cytarabine
to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
‒
Are 75 years of age or older, or
‒ Have other medical
conditions that prevent the use of standard chemotherapy.
It is not known if Venclexta is safe and effective in children.
Important Safety Information
Venclexta can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown
of cancer cells. TLS can cause kidney failure, the need for dialysis
treatment, and may lead to death. The patient’s doctor will do tests to
check their risk of getting TLS before they start taking Venclexta. The
patient will receive other medicines before starting and during
treatment with Venclexta to help reduce the risk of TLS. The patient may
also need to receive intravenous (IV) fluids through their vein.
The patient’s doctor will do blood tests to check for TLS when the
patient first starts treatment and during treatment with Venclexta. It
is important for patients to keep appointments for blood tests. Patients
should tell their doctor right away if they have any symptoms of TLS
during treatment with Venclexta, including fever, chills, nausea,
vomiting, confusion, shortness of breath, seizures, irregular heartbeat,
dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Patients should drink plenty of water during treatment with Venclexta
to help reduce the risk of getting TLS.
Patients should drink 6 to 8 glasses (about 56 ounces total) of water
each day, starting 2 days before the first dose, on the day of the first
dose of Venclexta, and each time a dose is increased.
The patient’s doctor may delay, decrease the dose, or stop treatment
with Venclexta if the patient has side effects.
Certain medicines must not be taken when the patient first starts
taking Venclexta and while the dose is being slowly increased because of
the risk of increased tumor lysis syndrome.
-
Patients must tell their doctor about all the medicines they take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Venclexta and other medicines may affect each other,
causing serious side effects. -
Patients must not start new medicines during treatment with Venclexta
without first talking with their doctor.
Before taking Venclexta, patients must tell their doctor about
all of their medical conditions, including if they:
- Have kidney problems.
-
Have problems with body salts or electrolytes, such as potassium,
phosphorus, or calcium. - Have a history of high uric acid levels in the blood or gout.
-
Are scheduled to receive a vaccine. The patient should not receive a
“live vaccine” before, during, or after treatment with Venclexta,
until the patient’s doctor tells them it is okay. If the patient is
not sure about the type of immunization or vaccine, the patient should
ask their doctor. These vaccines may not be safe or may not work as
well during treatment with Venclexta. -
Are pregnant or plan to become pregnant. Venclexta may harm an unborn
baby. If the patient is able to become pregnant, the patient’s doctor
should do a pregnancy test before the patient starts treatment with
Venclexta, and the patient should use effective birth control during
treatment and for at least 30 days after the last dose of Venclexta.
If the patient becomes pregnant or thinks they are pregnant, the
patient should tell their doctor right away. -
Are breastfeeding or plan to breastfeed. It is not known if Venclexta
passes into the patient’s breast milk. Patients should not breastfeed
during treatment with Venclexta.
What to avoid while taking Venclexta:
Patients should not drink grapefruit juice, eat grapefruit, Seville
oranges (often used in marmalades), or starfruit while they are taking
Venclexta. These products may increase the amount of Venclexta in the
patient’s blood.
Venclexta can cause serious side effects, including:
-
Low white blood cell counts (neutropenia). Low white blood cell
counts are common with Venclexta, but can also be severe. The
patient’s doctor will do blood tests to check their blood counts
during treatment with Venclexta. Patients should tell their doctor
right away if they have a fever or any signs of an infection during
treatment with Venclexta.
The most common side effects of Venclexta when used in combination
with rituximab in people with CLL include low white blood cell
counts; diarrhea; upper respiratory tract infection; cough; tiredness;
and nausea.
The most common side effects of Venclexta when used alone in people
with CLL/SLL include low white blood cell counts; diarrhea; nausea;
upper respiratory tract infection; low red blood cell counts; tiredness;
low platelet counts; muscle and joint pain; swelling of arms, legs,
hands, and feet; and cough.
The most common side effects of Venclexta in combination with
azacitidine, or decitabine, or low-dose cytarabine in people with AML
include low white blood cell counts; nausea; diarrhea; low platelet
counts; constipation; fever with low white blood cell counts; low red
blood cell counts; infection in blood; rash; dizziness; low blood
pressure; fever; swelling of arms, legs, hands, and feet; vomiting;
tiredness; shortness of breath; bleeding; infection in lung; stomach
(abdominal) pain; pain in muscles or back; cough; and sore throat.
Venclexta may cause fertility problems in males. This may affect the
ability to father a child. Patients should talk to their doctor if they
have concerns about fertility.
These are not all the possible side effects of Venclexta. Patients
should tell their doctor about any side effect that bothers them or that
does not go away.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Venclexta.com
for the Venclexta full Prescribing Information, including Patient
Information, for additional Important Safety Information.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach to CD20,
a protein found only 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 underway across a range of blood cancers.
Gazyva 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. -
With chemotherapy, followed by Gazyva alone in those who responded, to
treat stage II bulky, III, or IV FL in adults who have not had
previous FL treatment.
Important Safety Information
The most important safety information patients should know about
Gazyva
Patients must tell their doctor right away about any side effect 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 the patient has a 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 them for hepatitis B before, and
monitor the patient for hepatitis during and after, their 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. The
patient’s weakened immune system could put them 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
Who should not receive Gazyva:
Patients should NOT receive Gazyva if they have had an
allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients
must tell their healthcare provider if they have had an allergic
reaction to obinutuzumab or any other ingredients in Gazyva in the past
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effect 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 the patient has a reaction,
the infusion is either slowed or stopped until their symptoms are
resolved. Most patients are able to complete infusions and receive
medication again. However, if the infusion reaction is life
threatening, 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. Symptoms of
infusion reactions may include: fast heartbeat, tiredness, dizziness,
headache, redness of the face, nausea, chills, fever, vomiting,
diarrhea, rash, high blood pressure, low blood pressure, difficulty
breathing, and chest discomfort -
Hypersensitivity Reactions Including Serum Sickness: Some
patients receiving Gazyva may have severe or life-threatening allergic
reactions. This reaction may be severe, may happen during or after an
infusion, and may affect many areas of the body. If an allergic
reaction occurs, the patient’s doctor will stop the infusion and
permanently discontinue Gazyva -
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 the patient is taking Gazyva, they may
develop infections. Some of these infections may be fatal and severe,
so the patient should be sure to talk to their doctor if they think
they have an infection. Patients administered Gazyva in combination
with chemotherapy, followed by Gazyva alone are at a high risk of
infections during and after treatment. Patients with a history of
recurring or chronic infections may be at an increased risk of
infection.
Contacts
Media Contact:
Courtney Aberbach (650) 467-6800
Advocacy Contact:
Angela Wilson (202) 423-2739
Investor Contacts:
Loren Kalm (650) 225-3217
Karl Mahler 011
41 61 687 8503