Genentech Showcases New Clinical Data Across A Variety Of Blood Diseases At American Society of Hematology 2016 Annual Meeting

• New results from the Phase III GALLIUM study which compared Gazyva^® (obinutuzumab) plus chemotherapy to Rituxan^® (rituximab) plus chemotherapy in previously untreated follicular lymphoma will be presented in the Plenary Scientific Session
• New results for Venclexta™ (venetoclax) and investigational medicine emicizumab will also be presented at the meeting
• FDA has accepted the Biologics License Application for a subcutaneous formulation of Rituxan^® (rituximab/hyaluronidase)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that more than 60 abstracts featuring nine of its approved or investigational medicines will be presented during the 58th American Society of Hematology (ASH) Annual Meeting from December 3-6 in San Diego. The abstracts include more than 20 oral presentations across a broad range of medicines and combinations.

“The breadth of data we are presenting at ASH this year reflects our deep commitment to people with blood diseases”

“The breadth of data we are presenting at ASH this year reflects our deep commitment to people with blood diseases,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan plus chemotherapy.”

The results from the Phase III GALLIUM study have been selected for presentation during the Plenary Scientific Session, which honors the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Results from other studies of Gazyva will also be presented at the meeting, including an overall survival update from the Phase III GADOLIN study in Rituxan-refractory indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and the first results from the Phase III GOYA study in previously untreated diffuse large B-cell lymphoma (DLBCL).

Updated results from the Phase III SABRINA study comparing subcutaneous and intravenous Rituxan in previously untreated follicular lymphoma will be presented. The U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017. Genentech and Biogen collaborate on Rituxan and Gazyva in the United States.

Early results will be shared for combinations of Venclexta with either Gazyva or Rituxan in chronic lymphocytic leukemia (CLL) and certain types of NHL. Further follow-up from early studies in multiple myeloma (MM) and acute myeloid leukemia (AML) that support further investigation of Venclexta in these diseases will also be presented. Venclexta is being developed by AbbVie and Genentech.

The first cohort from a non-interventional study of people with hemophilia will be presented, including real world safety and efficacy data from patients with inhibitors to factor VIII replacement therapy treated with current standard of care according to routine clinical practice. Separately, there are currently three pivotal studies underway to explore the safety and efficacy of emicizumab in the treatment of hemophilia A: a Phase III study in people 12 years of age or older with hemophilia A with factor VIII inhibitors investigating weekly dosing; a Phase III study in people younger than 12 years of age with factor VIII inhibitors investigating weekly dosing; and a Phase III study in people 12 years of age or older without factor VIII inhibitors investigating weekly and every other week dosing. Emicizumab was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Genentech.

Key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.

Follow Genentech on Twitter via @Genentech and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH16.

Overview of key presentations featuring Genentech medicines at ASH 2016
Medicine		Abstract title		Abstract number/ Presentation details
Gazyva (investigational use)		Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study		#6 (Plenary Scientific Session) Sunday, Dec. 4 2:00–4:00 PM PT
		Minimal Residual Disease Assessment in Patients with Follicular Lymphoma Treated with Obinutuzumab or Rituximab as First-Line Induction Immunochemotherapy in the Phase III GALLIUM Study		#613 (Oral presentation) Monday, Dec. 5 7:00 AM PT (7:00–8:30 AM PT)
		Obinutuzumab or Rituximab plus CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Final Results from an Open Label, Randomized Phase 3 Study (GOYA)		#470 (Oral presentation) Sunday, Dec. 4 4:45 PM PT (4:30–6:00 PM PT)
Gazyva (approved use, updated study results)		Obinutuzumab plus Bendamustine Followed by Obinutuzumab Maintenance Prolongs Overall Survival Compared with Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Updated Results of the GADOLIN Study		#615 (Oral presentation) Monday, Dec. 5 7:30 AM PT (7:00–8:30 AM PT)
Rituxan (subcutaneous formulation) (investigational)		Longer Term Efficacy and Safety of Subcutaneous Compared with Intravenous Rituximab: Updated Results of the Phase III SABRINA Study		#1103 (Oral presentation) Monday, Dec. 5 5:30 PM PT (4:30–6:00 PM PT)
Venclexta (investigational use)		Safety and Efficacy of Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Coexisting Medical Conditions: Final Results of the Run-In Phase of the Randomized CLL14 Trial		#2054 (Poster) Saturday, Dec. 3 5:30–7:30 PM PT
		Results of a Phase Ib Study of Venetoclax plus R- or G-CHOP in Patients with B-cell Non-Hodgkin Lymphoma (CAVALLI)		#3032 (Poster) Sunday, Dec. 4 6:00–8:00 PM PT
		Phase 2 Study of Venetoclax plus Rituximab or Randomized Venetoclax plus Bendamustine+Rituximab (BR) Versus BR in Patients with Relapsed/Refractory Follicular Lymphoma: Interim Data (CONTRALTO)		#617 (Oral presentation) Monday, Dec. 5 8:00 AM PT (7:00–8:30 AM PT)
		Safety and Efficacy of Venetoclax plus Low-Dose Cytarabine in Treatment-Naive Patients Aged =65 Years with Acute Myeloid Leukemia (M14-387)		#2843 (Oral presentation) Saturday, Dec. 3 10:45 AM PT (9:30–11:30 AM PT)
Emicizumab (investigational)		Bleeding Events and Safety Outcomes in Patients with Hemophilia A with Inhibitors: A Prospective, Multicenter, Non-Interventional Study		#3800 (Poster) Monday, Dec. 5 6:00–8:00 PM PT

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?

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