– Ten Genentech medicines will be featured in more than 70 abstracts and 21 oral presentations, across a range of 15 blood cancers and non-malignant hematological conditions –
– New data for CD20-CD3 bispecific cancer immunotherapies confirms their potential in difficult-to-treat lymphomas –
– Long-term data and novel secondary endpoint analysis on Venclexta combinations in certain blood cancers –
– New analyses support Genentech’s portfolio for rare non-malignant blood conditions, including Hemlibra in hemophilia A and crovalimab in paroxysmal nocturnal hemoglobinuria –
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data for its approved and investigational medicines across a range of blood diseases will be presented at the 61st American Society of Hematology (ASH) Annual Meeting from December 7–10 in Orlando, Florida. Ten Genentech medicines will be featured in more than 70 abstracts and 21 oral presentations. These data feature results in 15 blood diseases across numerous molecular targets and combinations, as well as different clinical endpoints that Genentech is exploring.
“We are proud to present a broad range of data at ASH this year, and of the progress and commitment these data represent,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We believe that our science-driven approach to therapeutic development will continue to provide new options for people with aggressive blood cancers and rare blood diseases.”
Key data presentations in non-Hodgkin’s lymphoma (NHL)
Genentech will present data for two CD20-CD3 T-cell engaging bispecific antibodies in NHL (mosunetuzumab and CD20-TCB), including a Plenary Session discussing the Phase I/Ib GO29781 study results of mosunetuzumab in people with poor prognosis NHL, which includes those who have had prior chimeric antigen receptor T-cell therapy. The Plenary Session highlights the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Additionally, Genentech will present new preliminary data evaluating CD20-TCB in combination with other Genentech medicines.
Follow-up data on the pivotal Phase Ib/II GO29365 study, investigating Polivy™ (polatuzumab vedotin-piiq), a first-in-class antibody drug conjugate, in combination with Rituxan® (rituximab) and bendamustine in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will also be presented. This study was the basis of Polivy’s accelerated approval by the U.S. Food and Drug Administration (FDA) in June 2019 for people with R/R DLBCL who have received at least two prior therapies, and has been submitted to other health authorities around the world for approval consideration.
Key data presentations in chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)
Additionally, Genentech will be sharing results from three studies of Venclexta® (venetoclax) representing chemotherapy-free treatment options for certain people with leukemia. Further long-term follow-up data from the pivotal Phase III MURANO study in CLL will be presented, as well as an updated analysis from the pivotal Phase III CLL14 study with progression-free survival as the primary endpoint and minimal residual disease as a secondary endpoint, confirming the potential of Venclexta as a fixed-duration treatment option. Results of the investigational medicine idasanutlin, an oral MDM2 inhibitor, in combination with Venclexta in elderly patients with R/R AML will be shared. Additionally, new data will be presented for Venclexta as a first-line treatment in MDS, a rare form of blood cancer that affects the bone marrow. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group.
Key data presentations in rare non-malignant blood conditions
Finally, data for rare blood conditions, including hemophilia A and paroxysmal nocturnal hemoglobinuria (PNH) will be presented. New analyse from the Phase III HAVEN 3 study of Hemlibra® (emicizumab-kxwh) in people with hemophilia A without factor VIII inhibitors will be presented. The analyses include data on the positive effect of Hemlibra on joint health, as well as additional data on the use of on-demand factor VIII replacement therapy to treat breakthrough bleeding in people receiving Hemlibra prophylaxis in the HAVEN 3 study compared to factor VIII prophylaxis in a non-interventional study. Genentech is also sharing Phase I/II data from the COMPOSER study, which assessed the investigational medicine crovalimab in people with PNH, a life-threatening disease where red blood cells are destroyed by the body’s immune system. Crovalimab, a novel humanized anti-C5 monoclonal antibody designed to block the complement system, which plays a key role in PNH, was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Roche and Genentech.
Key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.
|
Medicine |
Abstract title |
Abstract number/presentation details |
|
Mosunetuzumab (investigational) |
Mosunetuzumab Induces Complete Remissions in Poor Prognosis Non-Hodgkin Lymphoma Patients, Including Those Who Are Resistant to or Relapsing After Chimeric Antigen Receptor T-Cell (CAR-T) Therapies, and Is Active in Treatment through Multiple Lines |
#6 Oral presentation (session: plenary scientific session) Dec. 8, 2019 2:00 – 4:00 PM ET |
|
CD20-TCB (investigational) |
Dual CD20-Targeted Therapy With Concurrent CD20-TCB and Obinutuzumab Shows Highly Promising Clinical Activity and Manageable Safety in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma: Preliminary Results From a Phase Ib Trial |
#1584 Poster presentation (session: 626) Dec. 7, 2019 5:30 – 7:30 PM ET |
|
CD20-TCB, a Novel T-Cell-Engaging Bispecific Antibody, Can be Safely Combined with the Anti-PD-L1 Antibody Atezolizumab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma |
#2871 Poster presentation (session: 626) Dec. 8, 2019 6:00 – 8:00 PM ET
|
|
|
Polivy (approved use; updated study results) |
Polatuzumab Vedotin Plus Bendamustine with Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Updated Results of a Phase Ib/II Randomized Study |
#4081 Poster presentation (session: 626) Dec. 9, 2019 6:00 – 8:00 PM ET
|
|
Polivy (investigational) |
Polatuzumab Vedotin Plus Obinutuzumab and Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma: Primary Analysis of the Full Efficacy Population in a Phase Ib/II Trial |
#126 Oral presentation (session: 623) Dec. 7, 2019 10:45 AM ET |
|
Quality of Life (QoL) in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma (NHL) Treated With Polatuzumab Vedotin Plus Rituximab in the ROMULUS Study |
#4767 Poster presentation (session: 905) Dec. 9, 2019 6:00 – 8:00 PM ET |
|
|
Venclexta (approved use) |
Quantitative Analysis of Minimal Residual Disease (MRD) Shows High Rates of Undetectable MRD after Fixed-Duration Chemotherapy-Free Treatment and Serves As Surrogate Marker for Progression-Free Survival: A Prospective Analysis of the Randomized CLL14 Trial |
#36 Oral presentation (session: 642) Dec. 7, 2019 8:45 AM ET |
|
Four-Year Analysis of MURANO Study Confirms Sustained Benefit of Time-Limited Venetoclax-Rituximab (VenR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) |
#355 Oral presentation (session: 642) Dec. 8, 2019 7:30 AM ET
|
|
|
Venclexta (investigational) |
A Phase Ib Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Treatment-Naïve Patients with Higher-Risk Myelodysplastic Syndrome |
#568 Oral presentation (session: 637) Dec. 9, 2019 7:45 AM ET |
|
Phase I/II Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Dexamethasone as Targeted Therapy for Patients with t(11;14) Relapsed/Refractory Multiple Myeloma |
#926 Oral presentation (session: 653) Dec. 9, 2019 6:30 PM ET |
|
|
Idasanutlin (investigational) |
Updated Results from the Venetoclax (Ven) in Combination with Idasanutlin (Idasa) Arm of a Phase Ib Trial in Elderly Patients (Pts) with Relapsed or Refractory (R/R) AML Ineligible for Cytotoxic Chemotherapy |
#229 Oral presentation (session: 616) Dec. 7, 2019 2:00 PM ET |
|
Hemlibra (approved use) |
Bone and Joint Health Markers in Persons with Hemophilia A (PwHA) Treated with Emicizumab in HAVEN 3 |
#626 Oral presentation (session: 322) Dec. 9, 2019 10:45 AM ET |
|
Factor VIII Use in the Treatment of Breakthrough Bleeds in Hemophilia A Patients without Inhibitors on Emicizumab Prophylaxis: the Phase III HAVEN 3 Study Experience |
#2395 Poster presentation (session: 322) Dec. 8, 2019 6:00 – 8:00 PM ET |
|
|
Crovalimab (investigational) |
Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody crovalimab (SKY59): Results from the umbrella Phase I/II COMPOSER Trial in healthy volunteers and PNH patients |
#3745 Poster presentation (session: 508) Dec. 9, 2019 6:00 – 8:00 PM ET |
Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have had at least two prior therapies.
The approval of Polivy is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of Polivy.
Important Safety Information
Possible serious side effects
Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.
- Infections: Patients should contact their healthcare team, if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication, which may prevent some infections, before giving Polivy and monitor blood counts throughout treatment with Polivy
- Infusion-related reactions: A patient may experience fever, chills, rash, or breathing problems within 24 hours of the infusion
- Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as numbness and tingling
- Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
- Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
- Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication
Side effects seen most often
The most common side effects during treatment were
- Low blood cell counts (platelets, red blood cells, white blood cells)
- Nerve problems in arms and legs
- Tiredness or lack of energy
- Diarrhea
- Nausea
- Fever
- Decreased appetite
- Infections
Polivy may not be for everyone. A patient should talk to their doctor if they are
- Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby
- Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment
- Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.
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.Polivy.com for the full Prescribing Information for additional Important Safety Information.
Venclexta Indications
Venclexta is a prescription medicine used:
- To treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
-
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.
Venclexta was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how Venclexta works over a longer period of time.
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.
- Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient’s doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection 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 obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.
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. For more information, patients should ask their doctor or pharmacist.
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.
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:
Priscilla White (650) 467-6800
Advocacy Contact:
Eydith Comenencia Ortiz (650) 745-5210
Investor Contacts:
Loren Kalm (650) 225-3217
Karl Mahler +41 61 687 85 03