Friday, Dec 5, 2014

Genentech to Present Clinical Data from Six Different Medicines at American Society of Hematology (ASH) Annual Meeting

  • Presentations include data on Genentech’s broad portfolio of hematology medicines and emerging investigational agents including ACE910 (RG6013) in hemophilia A

South San Francisco, Calif. -- December 5, 2014 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on four investigational medicines and investigational uses for two approved hematology medicines will be presented during the 56th American Society of Hematology Annual Meeting, taking place from December 6-9. Of the 49 abstracts representing the breadth and depth of Genentech’s hematology portfolio, nine have been accepted for oral presentation during the meeting.

"We are excited about our contribution to ASH this year because we are presenting data across a range of diseases and treatment settings including combinations with Gazyva in a variety of blood cancers,” said Sandra Horning MD, chief medical officer and head of Global Product Development. “Blood diseases go beyond the oncology setting, and we will provide an update on our investigational hemophilia A medicine, ACE910, which is being developed to improve outcomes for people with this rare, but serious life-long condition."

Data to be presented at ASH in part focus on Genentech’s anti-CD20 medicines, Gazyva® (obinutuzumab) and Rituxan® (rituximab). Results from the maintenance phase of the Phase Ib study (GAUDI), investigating Gazyva in combination with chemotherapy or bendamustine in follicular lymphoma as well as preliminary safety results from the Phase IIIb study (GREEN) of Gazyva alone or in combination with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) will be featured. 

Beyond Genentech’s anti-CD20 medicines, data from multiple studies will be shown for venetoclax (GDC-0199/ABT-199), an investigational BCL-2 inhibitor being developed in collaboration with AbbVie, across a range of blood cancers. Genentech will also present new data on the investigational MDM2 antagonist RG7388 and updated data investigating the anti-CD79b antibody drug conjugate polatuzumab vedotin. 

Data from a Phase Ib study of ACE910 in people with hemophilia A, including those who have developed inhibitors against Factor VIII, will also be presented. ACE910 is an investigational bispecific antibody allowing for subcutaneous administration. ACE910 was initially developed by Chugai Pharmaceutical Co., Ltd. and was opted into by Roche Pharma Research and Early Development earlier in 2014.

Overview of key presentations featuring Genentech medicines

Medicine

Description of study

Abstract number

ACE910 (RG6013)
(investigational)

Safety and prophylactic efficacy profiles of ACE910, a humanized bispecific antibody mimicking the FVIII cofactor function, in Japanese hemophilia A patients both without and with FVIII inhibitors: first-in-patient Phase I study

Abstract
#691

Gazyva (investigational use)

Obinutuzumab (GA101) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or bendamustine for the first-line treatment of follicular NHL: final results from the maintenance phase of the Phase Ib GAUDI study

Abstract
#1743

Gazyva

(investigational use)

Preliminary safety results from the Phase IIIb GREEN study of obinutuzumab (GA101) alone or in combination with chemotherapy for previously untreated or R/R CLL

Abstract
#3345

Gazyva (investigational use)

A Phase Ib study of obinutuzumab combined with lenalidomide for relapsed/refractory follicular B-cell lymphoma

Abstract
#4458

Rituxan (investigational use)

Value of minimal residual disease (MRD) negative status at response evaluation in chronic lymphocytic leukemia (CLL): a review of response of two Phase III studies of the German CLL Study Group (GCLLSG)

Abstract
#23

Polatuzumab vedotin (investigational)

Updated results of a Phase II randomized study (ROMULUS) of polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed/refractory non-Hodgkin lymphoma

Abstract
#4457

RG7388
(investigational)

Phase I/Ib study of RG7388, a potent MDM2 antagonist, in acute myelogenous leukemia (AML) patients (pts)

Abstract
#116

Venetoclax (GDC-0199/ABT-199) (investigational)

A Phase II study of ABT-199 (GDC-0199) in patients with acute myelogenous leukemia (AML)

Abstract
#118

Venetoclax (investigational)

Determination of recommended Phase II dose of ABT-199 (GDC-0199) combined with rituximab (R) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)

Abstract

#325

Venetoclax
(investigational)

The BCL-2 inhibitor ABT-199 (GDC-0199) in combination with bendamustine and rituximab in patients with relapsed or refractory non-Hodgkin’s lymphoma

 

Abstract

#1722

Venetoclax (investigational)

Preliminary results of a Phase Ib study (GO28440) combining GDC-0199 (ABT-199) with bendamustine/rituximab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia

Abstract

#3337

Venetoclax (investigational)

Preliminary results of a Phase Ib study (GP28331) combining GDC-0199 (ABT-199) and obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL)

Abstract

#4687

Gazyva Indication 

Gazyva is a prescription medicine used with the chemotherapy chlorambucil, to treat CLL in adults who have not had previous CLL 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 monitor 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 a few 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: dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, chest pain
  • Tumor Lysis Syndrome (TLS): 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, 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. 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. Neutropenia can develop during or after treatment with Gazyva. It may also 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. 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

Most common side effects of Gazyva

The most common side effects of Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, and muscle and joint pain.

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. It is not known if Gazyva may harm the patient’s unborn baby or pass into the patient’s breast milk. The patient should use birth control while using Gazyva and for 12 months after treatment. The patient should speak to the doctor about discontinuing Gazyva if the patient is breastfeeding

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 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 full Prescribing Information, including Boxed WARNING, for additional Important Safety Information.

Rituxan Indications

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: 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 see the Rituxan full Prescribing Information, including Most Serious Side Effects, for additional important safety information at http://www.Rituxan.com.

About Genentech In Hematology

For more than 20 years, Genentech has been developing medicines with the goal of redefining 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 Rituxan and Gazyva, Genentech’s pipeline of investigational hematology medicines includes the antibody-drug conjugate polatuzumab vedotin, a small molecule antagonist of MDM2 and, in collaboration with AbbVie, the small molecule BCL-2 inhibitor venetoclax. Genentech’s dedication to developing novel molecules in hematology expands beyond oncology, with the development of the investigational hemophilia A treatment ACE910.

About Genentech


Founded more than 35 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

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