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Sunday, May 10, 2015

Pivotal Data for Genentech Medicines in Lung and Blood Cancers To Be Presented at ASCO

  • Genentech medicines to be featured in more than 275 abstracts during ASCO 2015
  • New pivotal results for two medicines, investigational ALK inhibitor alectinib in advanced non-small-cell lung cancer (NSCLC) and Gazyva® (obinutuzumab) in indolent non-Hodgkin's lymphoma (NHL)
  • Important data in advanced NSCLC for investigational cancer immunotherapy, MPDL3280A (anti-PDL1)
  • Additional results for investigational medicine cobimetinib in advanced BRAF-mutated melanoma, as well as Perjeta® (pertuzumab) for the neoadjuvant (pre-surgery) treatment of people with HER2-positive early breast cancer

South San Francisco, CA -- May 10, 2015 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that data from 10 of its approved cancer medicines and 10 investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 - June 2 in Chicago. These data demonstrate the strength of Genentech’s oncology pipeline, particularly in cancer immunotherapy and personalized medicine.

"We’re particularly excited about our data in different types of advanced lung cancer, including pivotal data for alectinib and results of the first randomized study of our investigational immunotherapy, MPDL3280A," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "These results build upon our long-standing commitment to improve outcomes for people with lung cancer, and we hope these data will help us bring new options to treat this devastating disease."

Updated results from studies of cobimetinib in combination with Zelboraf® (vemurafenib) will also be presented at ASCO. Cobimetinib is currently under review with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Data presented at ASCO for alectinib and Gazyva will support regulatory submissions, and the Gazyva data will be highlighted as part of ASCO's official press program. Genentech is also discussing interim data for MPDL3280A from the POPLAR study with the FDA as part of its Breakthrough Therapy Designation in lung cancer. Preliminary data will also be presented on investigational medicine venetoclax in NHL and multiple myeloma. The FDA recently granted Breakthrough Therapy Designation to venetoclax for people with relapsed/refractory chronic lymphocytic leukemia who have a genetic abnormality known as 17p deletion. 

Visit http://www.gene.com/asco for resources and perspectives from scientists, doctors and others in the cancer community on important topics at ASCO this year. Follow Genentech on Twitter via @Genentech.

Medicine

Abstract title

Abstract number

Alectinib (investigational)

Efficacy and safety of the ALK inhibitor alectinib in ALK+ non-small-cell lung cancer (NSCLC) patients who have failed prior crizotinib: An open-label, single-arm, global phase II study (NP28673)

 A phase II, open-label, multicenter study of the ALK inhibitor alectinib in an ALK+ non-small-cell lung cancer (NSCLC) U.S./Canadian population who had progressed on crizotinib (NP28761)

#8008 (oral)

Sunday May 31

8:00 AM CDT

#8019 (poster discussion)

Monday June 1

8:00 AM CDT

Cobimetinib (investigational)

Update of progression-free survival (PFS) and correlative biomarker analysis from coBRIM: Phase III study of cobimetinib (cobi) plus vemurafenib (vem) in advanced BRAF-mutated melanoma

 Extended follow-up results of phase Ib study (BRIM7) of vemurafenib (vem) with cobimetinib (cobi) in BRAF-mutant melanoma

#9006 (oral)

Saturday May 30

1:15 PM CDT

#9020

Monday June 1

1:15 PM CDT

Gazyva

(obinutuzumab; investigational use)

GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin’s lymphoma

**To be featured in an official ASCO Press Briefing on Saturday, May 30, 8:00 – 9:00 AM (CDT)

#LBA8502 (oral)

Monday June 1

9:45 AM CDT

MPDL3280A (anti-PDL1; investigational)

Efficacy, safety and predictive biomarker results from a randomized phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR)

Safety and efficacy of MPDL3280A (anti-PDL1) in combination with platinum-based doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)

 

A phase Ia study of MPDL3280A (anti-PDL1): Updated response and survival data in urothelial bladder cancer (UBC)

#8010 (oral)

Sunday May 31

4:30 PM CDT

#8030

Monday June 1

8:00 AM CDT

#4501 (oral)

Monday June 1

9:45 AM CDT

Perjeta (pertuzumab)

Five-year analysis of the phase II NeoSphere trial evaluating four cycles of neoadjuvant docetaxel (D) and/or trastuzumab (T) and/or pertuzumab (P)

#505 (oral)

Monday June 1

8:00 AM CDT

Venetoclax (investigational)

Interim results from a dose-escalation study of the BCL-2 inhibitor venetoclax (ABT-199/GDC-0199) plus bendamustine (B) and rituximab (R) in patients (pts) with relapsed/refractory (R/R) Non-Hodgkin’s Lymphoma (NHL).

 

Phase I interim safety and efficacy of venetoclax (ABT-199/GDC-0199) monotherapy for relapsed/refractory (R/R) multiple myeloma (MM).

Phase 1b interim results: Venetoclax (ABT-199/GDC-0199) in combination with bortezomib (BTZ) and dexamethasone (Dex) in relapsed/refractory (R/R) multiple myeloma (MM).

#8535 (poster) discussion)

Sunday May 31

8:00 AM CDT

#8576 (poster discussion)

Sunday May 31

8:00 AM CDT

#8580 (poster discussion)
Sunday May 31

8:00 AM CDT

About Genentech in Cancer Immunotherapy

For more than 30 years, Roche and Genentech have been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our personalized cancer immunotherapy research and development program includes more than 20 investigational candidates, seven of which are in clinical trials. All studies include the evaluation of biomarkers to guide our development and help identify the right treatment approach for each patient.

MPDL3280A (anti-PDL1) is our most advanced cancer immunotherapy, with 30 active clinical trials. Nine pivotal trials across certain types of lung, bladder, breast and kidney cancer are underway with two additional pivotal studies slated to begin later this year. We have six ongoing Phase III studies in lung cancer.

About Genentech in Lung Cancer 

Lung cancer is a major area of focus and investment for Roche and Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have two approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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® (rituximab). 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 continues to be investigated in a large clinical program, which includes the head-to-head Phase III GOYA study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in newly diagnosed (first-line) diffuse large B-cell lymphoma (DLBCL; an aggressive form of NHL) and the head-to-head Phase III GALLIUM study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in previously untreated (first-line) indolent non-Hodgkin’s lymphoma. Additional combination studies 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.

About Rituxan

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 

Most common side effects of Rituxan 

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 Zelboraf

Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. BRAF is mutated in approximately half of melanomas. A patient’s healthcare provider will perform a test to make sure that Zelboraf is right for the patient. Zelboraf is not used to treat melanoma with a normal BRAF gene. It is not known if Zelboraf is safe and effective in children under 18 years of age.

Zelboraf is now approved in more than 80 countries and has been used to treat more than 11,000 patients worldwide. Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, now a member of the Daiichi Sankyo Group.

Important Safety Information:


Zelboraf can cause serious side effects, including risk of cancers. Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take Zelboraf. Zelboraf may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Patients must talk with their healthcare provider about their risk for these cancers. Patients must check their skin and tell their doctor about skin changes including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients must tell their healthcare provider about any new symptoms that they get while taking Zelboraf.

While taking Zelboraf, patients should avoid sunlight. When they go outside, patients must wear clothes that protect their skin, including their head, face, hands, arms and legs. Patients must use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

Possible serious side effects of Zelboraf include severe allergic reactions, severe skin reactions, potentially life-threatening changes in the electrical activity of the heart called QT prolongation, liver injury and eye problems. Patients must tell their doctor if they are pregnant or plan to become pregnant, as Zelboraf can harm a patient’s unborn baby.

Common side effects of Zelboraf include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching or warts.

Patients must tell their doctor if they have any side effect that bothers them or does not go away. These are not all of the possible side effects of Zelboraf. For more information about side effects, 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 .

Patients should read the full Prescribing Information and Medication Guide for additional Important Safety Information at http://www.zelboraf.com.

About Perjeta 

Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or “dimerizing”) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumor growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive blockade of HER signaling pathways, thus preventing tumor cell growth and survival.

Perjeta Indication Statements

Perjeta is approved for use in combination with Herceptin and docetaxel chemotherapy in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Perjeta is approved for use prior to surgery in combination with Herceptin and docetaxel chemotherapy in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than two centimeters in diameter or node positive) breast cancer. Perjeta should be used as part of a complete treatment regimen for early stage breast cancer. This use of Perjeta is based on an improvement in the percentage of people who had no evidence of cancer in the breast or lymph nodes at the time of surgery. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta as part of a doxorubicin (chemotherapy)-containing regimen has not been established. The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established.

Important Safety Information  

Perjeta may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

  • A patient’s doctor may run tests to monitor the patient’s heart function before and during treatment with Perjeta.
  • Based on test results, the doctor may decide to hold or discontinue treatment with Perjeta.

Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.

  • Birth control should be used while receiving Perjeta and for six months after a patient’s last dose of Perjeta. If a patient is a mother who is breastfeeding, the patient should talk with her doctor about either stopping breastfeeding or stopping Perjeta.
  • If a patient thinks she may be pregnant, the patient should contact their healthcare provider immediately.
  • If a patient is exposed to Perjeta during pregnancy, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720.

Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.

Other possible serious side effects of Perjeta therapy include:

  • Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving Perjeta, Herceptin and docetaxel chemotherapy were feeling tired, abnormal or altered taste, allergic reactions, muscle pain and vomiting. The most common infusion-related reactions when receiving Perjeta alone were fever, chills, feeling tired, headache, weakness, allergic reactions and vomiting.
  • Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly and may affect many areas of the body.

Perjeta has only been shown to work in people with HER2-positive breast cancer. 

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without a fever
  • Nausea
  • Feeling tired
  • Rash
  • Damage to the nerves (numbness, tingling, pain in hands/feet)

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy as part of an early stage breast cancer regimen before surgery are:

  • Hair loss
  • Diarrhea
  • Nausea
  • Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy following three cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early stage breast cancer regimen before surgery are:

  • Feeling tired
  • Hair loss
  • Diarrhea
  • Nausea
  • Vomiting
  • Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin, docetaxel chemotherapy and carboplatin chemotherapy as part of an early stage breast cancer regimen before surgery are:

  • Feeling tired
  • Hair loss
  • Diarrhea
  • Nausea
  • Vomiting
  • Low levels of white blood cells with or without a fever
  • Low platelet count
  • Low levels of red blood cells

Report side effects to Genentech and the FDA. 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 Perjeta full Prescribing Information including Most Serious Side Effect for additional Important Safety Information at http://www.perjeta.com.

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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