Wednesday, May 10, 2017
South San Francisco, CA -- May 10, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data on 20 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, in Chicago. More than 190 abstracts have been accepted, including two “late breakers” and 24 oral presentations.
“We are making significant advances with personalized medicines and cancer immunotherapies,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With continued research and collaborations, we are striving to develop medicines and combinations, incorporate sophisticated diagnostics and integrate big data in our effort to get closer to the goal of curing cancer.”
Key highlights from the Genentech oncology portfolio include new results from the APHINITY study in early breast cancer and ALEX study in lung cancer. Both of these studies will be highlighted as part of ASCO’s official press program on Monday, June 5. APHINITY is a randomized Phase III study, investigating Perjeta plus Herceptin® (trastuzumab) and chemotherapy as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer. The APHINITY study was conducted in collaboration with the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS). ALEX is a randomized, multicenter, open-label Phase III study that compared Alecensa and crizotinib in people with previously untreated ALK-positive non-small cell lung cancer (NSCLC).
There has been great progress in the area of cancer immunotherapy in recent years, and Genentech continues to investigate novel ways to harness the immune system in the fight against cancer as part of its vision to bring the next generation of cancer immunotherapies to patients. With more than 20 investigational cancer immunotherapies in development and 12 in clinical trials, Genentech will be presenting early results on its first T-cell bispecific antibody (CEA-CD3 TCB: RG7802; RO6958688) for the treatment of CEA-positive cancers, including metastatic colorectal cancer (mCRC). These data have been generated from two ongoing dose-escalation Phase I studies in which CEA-CD3 TCB is used alone or in combination with Tecentriq® (atezolizumab).
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 2017 Annual Meeting news and updates by using the hashtag #ASCO17.
Key presentations featuring Genentech medicines at ASCO 2017
|
Medicine |
Abstract title |
Abstract number |
|
Perjeta (pertuzumab) (investigational use) |
APHINITY trial (BIG 4-11): A randomized comparison of chemotherapy (C) plus trastuzumab (T) plus placebo (Pla) versus chemotherapy plus trastuzumab (T) plus pertuzumab (P) as adjuvant therapy in patients (pts) with HER2-positive early breast cancer (EBC) |
Abstract LBA500 (oral) Monday, June 5 9:45 AM - 12:45 PM CDT |
|
Alecensa (alectinib) (investigational use) |
Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study |
Abstract LBA9008 (oral) Tuesday, June 6 9:45 AM - 12:45 PM CDT |
|
CEA-CD3 TCB (RG7802) (investigational use) |
Phase Ia and Ib studies of the novel carcinoembryonic antigen (CEA) T-cell bispecific (CEA CD3 TCB) antibody as a single agent and in combination with atezolizumab: Preliminary efficacy and safety in patients with metastatic colorectal cancer (mCRC) |
Abstract 3002 (oral) Monday, June 5 1:15 - 4:15 PM CDT |
|
CEA-CD3 TCB (RG7802) (investigational use) |
Pharmacokinetics (PK) and pharmacodynamics (PD) of a novel carcinoembryonic antigen (CEA) T-cell bispecific antibody (CEA CD3 TCB) for the treatment of CEA-expressing solid tumors |
Abstract 2549 (poster) Monday, June 5 8:00 - 11:30 AM CDT |
|
ipatasertib (investigational use) |
LOTUS (NCT02162719): A double-blind placebo (PBO)-controlled randomized phase II trial of first-line ipatasertib (IPAT) + paclitaxel (P) for metastatic triple-negative breast cancer (TNBC) |
Abstract 1009 (poster) Sunday, June 4 4:45 - 6:00 PM CDT |
|
Tecentriq (atezolizumab) (investigational use) |
IMmotion150: A phase II trial in untreated metastatic renal cell carcinoma (mRCC) patients (pts) of atezolizumab (atezo) and bevacizumab (bev) vs and following atezo or sunitinib (sun) |
Abstract 4505 (oral) Monday, June 5 8:00 - 10:00 AM CDT |
|
Tecentriq (atezolizumab) (investigational use) |
Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study |
Abstract 9092 (poster) Saturday, June 3 8:00 - 11:30 AM CDT |
|
Tecentriq (atezolizumab) (investigational use) |
Clinical activity, safety and biomarker results from a phase Ia study of atezolizumab (atezo) in advanced/recurrent endometrial cancer (rEC) |
Abstract 5585 (poster) Saturday, June 3 1:15 - 4:45 PM CDT |
|
Tecentriq (atezolizumab) (investigational use) |
Impact of atezolizumab (atezo) treatment beyond disease progression (TBP) in advanced NSCLC: Results from the randomized phase III OAK study |
Abstract 9001 (oral) Tuesday, June 6 9:45 AM - 12:45 PM CDT |
|
Tecentriq/IDO1 (atezolizumab/GDC-0919) (investigational use) |
A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors |
Abstract 105 (oral) Sunday, June 4 9:45 - 11:15 AM CDT |
About Perjeta
Perjeta is approved for use in combination with Herceptin and docetaxel 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 patients whose cancer shrinks or disappears after treatment. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival.
Important Safety Information
Side effects with Perjeta
Most serious side effects
Perjeta may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).
Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.
Other possible serious side effects
Knowing if Perjeta is right for the patient
Perjeta has only been shown to work in people with HER2-positive breast cancer. A patient must have a HER2 test to know if their breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as Perjeta.
Most common side effects
The most common side effects of Perjeta when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:
The most common side effects of Perjeta when given with Herceptin and docetaxel as part of an early breast cancer regimen before surgery are:
The most common side effects of Perjeta when given with Herceptin and docetaxel following three cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early breast cancer regimen before surgery are:
The most common side effects of Perjeta when given with Herceptin, docetaxel and carboplatin as part of an early breast cancer regimen before surgery are:
Patients are encouraged to 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 the full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.perjeta.com.
About Herceptin
Adjuvant Breast Cancer
Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:
Patients are selected for therapy based on an FDA-approved test for Herceptin.
*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
Herceptin has two approved uses in metastatic breast cancer:
Patients are selected for therapy based on an FDA-approved test for Herceptin.
Gastric Cancer
Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
Important Safety Information
Possible serious side effects with Herceptin
Not all people have serious side effects, but side effects with Herceptin therapy are common.
Although some people may have a life-threatening side effect, most do not.
A patient’s doctor will stop treatment if any serious side effects occur.
Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin.
INFUSION REACTIONS, including:
These signs usually happen within 24 hours after receiving Herceptin.
A patient should be sure to contact their doctor if they:
Are a woman who could become pregnant, or may be pregnant
Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and after a patient's last dose of Herceptin. If a patient is exposed to Herceptin during pregnancy or within seven months of becoming pregnant, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720 or visiting http://www.motherpregnancyregistry.com and to report Herceptin exposure to Genentech at (888) 835-2555.
Have any signs of SEVERE LUNG PROBLEMS, including:
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone.
A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.
Side effects seen most often with Herceptin
Some patients receiving Herceptin for breast cancer had the following side effects:
Some patients receiving Herceptin for metastatic stomach cancer had the following side effects:
Low white blood cell counts
A patient should contact their doctor immediately if they have any of the side effects listed above.
Patients are encouraged to 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 the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at http://www.herceptin.com.
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 3 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:
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 Tecentriq
Tecentriq is a prescription medicine used to treat:
a type of bladder and urinary tract cancer called urothelial carcinoma.
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
a type of lung cancer called non-small cell lung cancer (NSCLC)
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if Tecentriq is safe and effective in children.
Important Safety Information
Important Information About Tecentriq
Tecentriq can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if a patient has severe side effects.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
Tecentriq can cause serious side effects, including:
Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq in people with urothelial carcinoma include:
The most common side effects of Tecentriq in people with non-small cell lung cancer include:
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the Tecentriq full Prescribing Information for additional Important Safety Information.
About Genentech
Founded more than 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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