Monday, May 2, 2016
South San Francisco, CA -- May 2, 2016 --
SOUTH SAN FRANCISCO, Calif. – May 2, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from June 3 - 7 in Chicago. More than 200 abstracts have been accepted across eight cancer types, including four “late breakers” and nearly 30 oral presentations.
“The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “At this year’s ASCO meeting, we look forward to presenting results from studies that have the potential to define new treatment approaches for cancers that have not seen significant progress in decades.”
New trial results for atezolizumab include data from a study in which people
received the medicine as an initial treatment for metastatic bladder cancer (first-line). These data will be highlighted as part of ASCO’s official press program. New overall survival and diagnostic results will be presented in recurrent metastatic bladder and lung cancers, and results from early combination studies of atezolizumab with targeted medicines and the investigational cancer immunotherapy MOXR0916, an OX40 agonist, will also be featured.
Genentech will be presenting data from the J-ALEX trial, an open-label, randomized Phase III study that compared Alecensa to crizotinib in people with anaplastic lymphoma kinase (ALK)-positive advanced or recurrent NSCLC who had not previously received an ALK inhibitor and who had a maximum of one prior treatment with a chemotherapy.
Results for Genentech’s hematology medicines include data from a study of Rituxan® (rituximab) in children with high-risk B-cell non-Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL). Results from Phase I/II studies of Venclexta™ (venetoclax) in acute myeloid leukemia (AML), as well as the first data from a Phase Ib study of Venclexta in B-cell NHL in combination with either Rituxan and CHOP chemotherapy or Gazyva® (obinutuzumab) and CHOP chemotherapy, will also be presented. Venclexta is being developed by AbbVie and Genentech. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialized by AbbVie outside of the United States.
Visit http://www.gene.com/asco for resources and perspectives from scientists, doctors and others in the cancer community on important topics at ASCO. Follow Genentech on Twitter via @Genentech and keep up to date with ASCO 2016 Annual Meeting news and updates by using the hashtag #ASCO16.
Overview of key presentations featuring Genentech medicines at ASCO 2016
|
Medicine |
Abstract title |
Abstract number |
|
atezolizumab (investigational) |
Atezolizumab (atezo) as first-line (1L) therapy in cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (mUC): primary analysis of IMvigor210 cohort 1 |
Abstract #LBA4500 (oral) Sunday, June 5 8:00 - 11:00 AM CDT |
|
Updated efficacy and > 1-y follow up from IMvigor210: Atezolizumab (atezo) in platinum (plat) treated locally advanced/metastatic urothelial carcinoma (mUC) |
Abstract #4515 (oral) Sunday, June 5 8:00 - 11:00 AM CDT |
|
|
Updated survival and biomarker analyses of a randomized Phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR) |
Abstract #9028 (poster) Saturday, June 4 8:00 - 11:30 AM CDT |
|
|
Correlation of peripheral and intratumoral T-cell receptor (TCR) clonality with clinical outcomes in patients with metastatic urothelial cancer (mUC) treated with atezolizumab |
Abstract #3005 (oral) Saturday, June 4 1:15 - 4:15 PM CDT |
|
|
A Phase Ib dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors |
Abstract #101 (oral) Saturday, June 4 8:00 - 9:30 AM CDT |
|
|
Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC) |
Abstract #3502 (oral) Sunday, June 5 8:00 - 11:00 AM CDT |
|
|
Phase Ib trial of atezolizumab in combination with nab-paclitaxel in patients with metastatic triple negative breast cancer (mTNBC) |
Abstract #1009 (poster discussion) Sunday, June 5 4:45 - 6:00 PM CDT |
|
|
Alecensa (alectinib) (investigational use) |
Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC): Primary results from the J-ALEX study |
Abstract #9008 (oral) Monday, June 6 9:45 AM - 12:45 PM CDT |
|
ipatasertib (investigational) |
Randomized Phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study) |
Abstract #5017 (poster discussion) Saturday, June 4 4:45 - 6:00 PM CDT |
|
Rituxan (rituximab) (investigational use) |
Results of the randomized Intergroup trial Inter-B-NHL Ritux 2010 for children and adolescents with high-risk B-cell non-Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL): Evaluation of rituximab (R) efficacy in addition to standard LMB chemotherapy (CT) regimen |
Abstract #10507 (oral) Friday, June 3 3:00 - 6:00 PM CDT |
|
Venclexta (venetoclax) (investigational use) |
Results of a Phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥65 years ineligible for standard induction therapy |
Abstract #7009 (poster discussion) Monday, June 6 11:30 AM - 12:45 PM CDT |
|
Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients age ≥65 with acute myelogenous leukemia |
Abstract #7007 (oral) Saturday, June 4 3:00 - 6:00 PM CDT |
|
|
Phase 1b study of venetoclax plus R- or G-CHOP in patients with B-cell non-Hodgkin lymphoma |
Abstract #7566 (poster) Monday, June 6 8:00 - 11:30 AM CDT |
About Genentech in Personalized Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, nine of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/immunotherapy.
About Alecensa
Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
This indication is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Important Safety Information
Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.
A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.
Alecensa may cause serious side effects, including:
Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 2 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:
Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:
Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.
Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:
· Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant
o Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of Alecensa
o Men who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa
· Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their doctor about the best way to feed their baby during this time.
Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.
The most common side effects of Alecensa include:
These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in full Prescribing Information , including Patient Information .
About Venclexta
Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
This indication is approved under an accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Important Safety Information
Strong CYP3A inhibitors, a certain type of medicine, must not be taken when patients first start taking Venclexta and while their dose is being slowly increased.
Patients must tell their doctor right away about any side effects they experience.
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. A patient’s doctor will do tests for TLS. It is important for patients taking Venclexta to keep their appointments for blood tests. Patients will receive other medicines before starting and during treatment with Venclexta to help reduce their risk of TLS. Patients may also need to receive intravenous (IV) fluids into their vein. Patients taking Venclexta 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 pain or joint pain.
Patients should drink plenty of water when taking 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 their first dose, on the day of their first dose of Venclexta, and each time the dose is increased.
Certain medicines must not be taken when patients first start taking Venclexta and while their dose is being slowly increased.
· Patients should not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients should tell their doctor about all of their medical conditions, including if they:
· Have problems with their body salts or electrolytes, such as potassium, phosphorus, or calcium.
· Have a history of high uric acid levels in their blood or gout.
· Are scheduled to receive a vaccine. Patients should not receive a “live vaccine” during or after treatment with Venclexta.
· Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If a patient is able to become pregnant, the doctor should do a pregnancy test before they start treatment with Venclexta, and they should use effective birth control during treatment and for 30 days after the last dose of Venclexta.
· Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into breast milk. Patients should not breastfeed during treatment with Venclexta.
Patients taking Venclexta should not drink grapefruit juice or 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:
The most common side effects of Venclexta include diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired.
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. Patients should tell their doctor if they have any side effect that bothers them or that does not go away.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
Please visit http://www.venclexta.com for the full Prescribing Information for additional Important Safety Information.
About Gazyva
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.
· 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:
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.
About Rituxan
Rituxan 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 or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who responded to 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.
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:
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.
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:
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.
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 visit http://www.Rituxan.com for the Rituxan full Prescribing Information, including Boxed WARNINGS and Medication Guide, for additional Important Safety Information.
About Genentech
Founded 40 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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