Saturday, May 30, 2015

Genentech’s Gazyva® Extended the Time People with Refractory Indolent Non-Hodgkin’s Lymphoma Lived Without Their Disease Worsening

GADOLIN is the second positive Phase III study in the Gazyva clinical development program

Genentech and Roche will submit data from the GADOLIN study to regulatory authorities in the United States, Europe and around the world for approval consideration

Chicago -- May 30, 2015 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III GADOLIN study showing that Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone provided significant benefit for people with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to Rituxan^® (rituximab)-based treatment. In the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death (progression-free survival, PFS) by 45 percent (HR=0.55, p=0.0001), compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected safety signals identified with Gazyva.

"Unfortunately, some people with indolent non-Hodgkin's lymphoma have disease that is refractory to Rituxan-based therapy, a standard of care treatment. We're excited by these data showing that Gazyva could help these people who have few treatment options remaining," said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

The late-breaking data from the GADOLIN study will be featured in the official press program of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, May 30, at 8:00 A.M. CDT. The data will be presented during ASCO’s 51st Annual Meeting by Dr. Laurie Sehn, British Columbia Cancer Agency/University of British Columbia (Abstract #LBA8502, Monday, June 1, 10:09-10:21 A.M. CDT), and subsequently at the 20th annual congress of the European Hematology Association (EHA) and the 13th International Conference on Malignant Lymphoma (ICML) in June 2015. 

Data from this pivotal study will be submitted to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.

About the GADOLIN Study 

GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone. GADOLIN included 413 patients with indolent NHL whose disease progressed during or within six months of prior Rituxan-based therapy. The primary endpoint of the study is progression-free survival (PFS) as assessed by an independent review committee (IRC), with secondary endpoints including PFS as assessed by investigator review, response rate (RR), best response and overall survival (OS).

Results to be presented at ASCO showed: 

• The median PFS was not reached in the Gazyva-based treatment group versus 14.9 months with bendamustine alone (HR=0.55, p=0.0001) as assessed by IRC.
• The median PFS with Gazyva-based treatment was more than double that with bendamustine alone (29.2 months vs. 14.0 months, HR=0.52, p<0.0001), as assessed by investigator review.
• No unexpected safety signals were identified in the Gazyva-based treatment arm. Grade 3-4 adverse events that occurred in at least two percent of patients in the Gazyva-treated group or bendamustine alone group included low white blood cell count (33 percent vs. 26.3 percent), low blood platelet count (10.8 percent vs. 16.2 percent), infusion-related reactions (10.8 percent vs. 5.6 percent), low red blood cell count (7.7 percent vs. 10.1 percent), low white blood cell count with fever (4.6 percent vs. 3.5 percent), nausea (1 percent vs. 3 percent), fatigue (1.5 percent vs. 2.5 percent), diarrhea (1 percent vs. 2.5 percent), vomiting (2.1 percent vs. 1 percent), respectively.

About Non-Hodgkin’s Lymphoma

There are two main types of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). NHL represents approximately 85 percent of all lymphomas diagnosed. There are more than 60 different types of NHL that fall under two subsets, aggressive and indolent (slow-growing). According to the American Cancer Society, it is expected that nearly 72,000 people will be diagnosed with NHL in the United States in 2015, and nearly 20,000 will die from the disease.

Most cases of NHL start in B-lymphocytes, cells that are part of the body’s immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymphatic system, such as lymph nodes, lymphatic tissues or the spleen. 

About Gazyva 

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body's immune system. Gazyva is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B-cells (antibody dependent cellular cytotoxicity; ADCC) when compared to Rituxan.  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 Idec.

Gazyva is being studied in a large clinical program, including the Phase III GOYA and GALLIUM studies. GOYA is comparing Gazyva head-to-head with Rituxan plus chemotherapy in first line diffuse large B-cell lymphoma (DLBCL) and GALLIUM is comparing Gazyva head-to-head with Rituxan plus chemotherapy in first line indolent NHL. Additional 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 Indication 

Gazyva 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.

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 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, and 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. 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. 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, nausea, and diarrhea. 

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. 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. 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 WARNINGS, 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. Patient 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 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. Genentech’s pipeline of potential hematology medicines includes an antibody-drug conjugate (anti-CD79b; polatuzumab vedotin), a small molecule antagonist of MDM2 (RG7388) and in collaboration with AbbVie, a 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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