— Study results reflect advancements in HER2-positive, triple-negative, and hormone receptor-positive breast cancer —
— Follow-up data from pivotal Phase III APHINITY study evaluating Perjeta plus Herceptin and chemotherapy in HER2-positive early breast cancer —
— Results from Phase III FeDeriCa study confirming the non-inferiority of a fixed-dose combination of Perjeta and Herceptin administered under the skin —
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019. These data include new results in HER2-positive breast cancer and studies of new molecules in hormone receptor-positive (HR-positive) breast cancer.
“For the past three decades, we have remained dedicated to improving outcomes for people with breast cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This sustained commitment is exemplified by new data for our approved and investigational medicines across the spectrum of breast cancer being presented at SABCS this year.”
Key presentations
New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC). This latest interim OS analysis also includes updated descriptive invasive disease-free survival and cardiac safety data.
Genentech will also present data from the primary analysis of the Phase III FeDeriCa study which evaluated a new investigational fixed-dose combination (FDC) of Perjeta and Herceptin administered as a single subcutaneous formulation in combination with intravenous chemotherapy. The FDC is administered under the skin in just minutes, significantly reducing the time spent receiving treatment and providing people with HER2-positive breast cancer a potential new treatment option for faster delivery of the Perjeta-based regimen.
Data will also be presented from studies in HR-positive breast cancer, including findings from early studies investigating Genentech’s pipeline molecules GDC-9545, a selective estrogen receptor degrader, and GDC-0077, a mutant selective PI3Kα inhibitor.
Overview of Genentech studies to be presented at SABCS 2019
|
Medicine(s) |
Abstract title |
Abstract number (date, time, location of presentation) |
|
HER2-positive breast cancer |
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|
Perjeta and Herceptin |
Interim OS analysis of APHINITY (BIG 4-11): a randomized multicenter, double-blind, placebo-controlled trial comparing chemotherapy plus trastuzumab plus pertuzumab versus chemotherapy plus trastuzumab plus placebo as adjuvant therapy in patients with operable HER2-positive eBC |
Abstract GS1-04 (Oral)
Wednesday, December 11 Hall 3 |
|
Perjeta and Herceptin |
Subcutaneous trastuzumab and hyaluronidase-oysk with intravenous pertuzumab and docetaxel in HER2-positive advanced breast cancer: final analysis of the Phase IIIb, multicenter, open-label, single-arm MetaPHER study |
Abstract P1-18-05 (Poster)
Wednesday, December 11 Hall 1 |
|
Perjeta and Herceptin |
Risk of recurrence and death in patients with early HER2-positive breast cancer who achieve a pathological complete response (pCR) after different types of HER2-targeted therapy: a retrospective exploratory analysis |
Abstract P1-18-01 (Poster)
Wednesday, December 11 Hall 1 |
|
Perjeta and Herceptin |
Use of pertuzumab in combination with taxanes for HER2-positive metastatic breast cancer (MBC): analysis of United States electronic health records |
Abstract P1-18-14 (Poster)
Wednesday, December 11 Hall 1 |
|
Kadcyla (ado-trastuzumab emtansine) |
Cardiac events in patients with HER2-positive MBC who have low left ventricular ejection fraction prior to initiating treatment with ado-trastuzumab emtansine: a retrospective cohort study using electronic health record data |
Abstract P1-18-11 (Poster)
Wednesday, December 11 Hall 1 |
|
Tecentriq (atezolizumab), Kadcyla, Perjeta and Herceptin |
Atezolizumab in combination with ado-trastuzumab emtansine or with trastuzumab and pertuzumab in patients with HER2-positive breast cancer and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer: safety and biomarker outcomes from a multi-cohort Phase Ib study |
Abstract PD1-05 (Poster discussion)
Wednesday, December 11 Hemisfair Ballroom |
|
Perjeta and Herceptin |
Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive eBC: primary analysis of the Phase III, multicenter, randomized, open-label, two-arm FeDeriCa study |
Abstract PD4-07 (Poster discussion) Thursday, December 12 7:00 – 9:00 AM CST Stars at Night Ballroom 1&2 |
|
Kadcyla and Perjeta |
Association of immune gene expression with outcome in the MARIANNE Phase III clinical trial in HER2-positive MBC |
Abstract PD5-11 (Poster discussion) Thursday, December 12 7:00 – 9:00 AM CST Stars at Night Ballroom 3&4 |
|
Kadcyla and Herceptin |
Adjuvant ado-trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: KATHERINE subgroup analysis |
Abstract P3-14-01 (Poster) Thursday, December 12 5:00 – 7:00 PM CST Hall 1 |
|
Herceptin |
Palbociclib in combination with trastuzumab and endocrine therapy versus treatment of physician’s choice in metastatic HER2-positive and HR-positive breast cancer with PAM50 luminal intrinsic subtype (SOLTI-1303 PATRICIA II): a multi-center, randomized, open-label, Phase II trial |
Abstract OT2-02-06 (Poster) Thursday, December 12 5:00 – 7:00 PM CST Hall 1 |
|
Kadcyla and Herceptin |
Cost-effectiveness of ado-trastuzumab emtansine versus trastuzumab for the adjuvant treatment of patients with residual invasive HER2-positive eBC in the United States |
Abstract P6-13-01 (Poster) Saturday, December 14 7:00 – 9:00 AM CST Hall 1 |
|
Hormone receptor-positive |
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|
GDC-0077 |
A first-in-human Phase Ia dose escalation study of GDC-0077, a p110a-selective and mutant-degrading PI3K inhibitor, in patients with PIK3CA-mutant solid tumors |
Abstract OT1-08-04 (Poster) Wednesday, December 11 5:00 – 7:00 PM CST Hall 1 |
|
GDC-0077 |
A Phase Ib dose escalation study evaluating the mutant selective PI3K-alpha inhibitor GDC-0077 in combination with letrozole with and without palbociclib in patients with PIK3CA-mutant HR-positive, HER2-negative breast cancer |
Abstract P1-19-46 (Poster) Wednesday, December 11 5:00 – 7:00 PM CST Hall 1 |
|
GDC-9545 |
A first-in-human Phase I study to evaluate the oral selective estrogen receptor degrader (SERD), GDC-9545, in postmenopausal women with HR-positive/HER2-negative MBC |
Abstract PD7-05 (Poster discussion) Thursday, December 12 5:00 – 7:00 PM CST Stars at Night Ballroom 1&2 |
|
Triple-negative breast cancer |
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|
Tecentriq |
Exploratory analytical harmonization of PD-L1 immunohistochemistry assays in advanced triple negative breast cancer (TNBC): a retrospective substudy of IMpassion130 |
Abstract PD1-07 (Poster discussion) Wednesday, December 11 5:00 – 7:00 PM CST Hemisfair Ballroom |
|
Tecentriq |
Systemic corticosteroid use in patients with metastatic TNBC treated with first-line therapy in the United States |
Abstract P2-15-09 (Poster) Thursday, December 12 7:00 – 9:00 AM CST Hall 1 |
|
ipatasertib |
Expression of PD-L1 is independent of PIK3CA/AKT1/PTEN alterations in TNBC and is not associated with response to ipatasertib plus paclitaxel
|
Abstract P4-10-23 (Poster) Friday, December 13 7:00 – 9:00 AM CST Hall 1 |
About Perjeta (pertuzumab)
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, dual blockade of HER signaling pathways, thus preventing tumor cell growth and survival.
Perjeta Indication Statement
Perjeta (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) 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 (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) and chemotherapy for:
- use prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than two centimeters in diameter or node-positive). Perjeta should be used as part of a complete treatment regimen for early breast cancer.
- use after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back.
Important Safety Information
Side effects with Perjeta
- Not all people have serious side effects; however, side effects with Perjeta therapy are common. It is important for patients to know what side effects may happen and what symptoms patients should watch for.
- A patient’s doctor may stop treatment if serious side effects happen. Patients should be sure to contact their healthcare team right away if they have questions or are worried about any side effects.
Most serious side effects of Perjeta
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, a patient’s doctor may hold or discontinue treatment with Perjeta.
- Patients should contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than five pounds in 24 hours, dizziness or loss of consciousness.
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 seven months after a patient’s last dose of Perjeta. If a patient is a mother who is breastfeeding, she should talk with her doctor about either stopping breastfeeding or stopping Perjeta.
- If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
- If a patient is exposed to Perjeta during pregnancy, or becomes pregnant while receiving Perjeta or within seven months following her last dose of Perjeta in combination with Herceptin, she is encouraged to report Perjeta exposure to Genentech at (888) 835-2555.
Other possible serious side effects
- Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.
- Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. Perjeta has been associated with infusion-related reactions, some fatal. The most common infusion-related reactions when receiving Perjeta, Herceptin and docetaxel 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, which may happen quickly and may affect many areas of the body. Severe allergic reactions, some fatal, have been observed in patients treated with 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:
- Diarrhea
- Hair loss
- Low levels of white blood cells with or without 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 chemotherapy as part of an early breast cancer regimen before surgery are:
- Constipation
- Damage to the nerves (numbness, tingling, pain in hands/feet)
- Diarrhea
- Feeling tired
- Hair loss
- Headache
- Low levels of red blood cells
- Low levels of white blood cells with or without fever
- Low platelet count
- Mouth blisters or sores
- Nausea
- Pain in the muscles
- Vomiting
- Weakness
Side effects may vary based on chemotherapy regimen.
The most common side effects of Perjeta when given with Herceptin and chemotherapy as part of an early breast cancer regimen after surgery are:
- Diarrhea
- Nausea
- Hair loss
- Feeling tired
- Damage to the nerves (numbness, tingling, pain in hands/feet)
- Vomiting
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 Perjeta full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.perjeta.com.
About Herceptin (trastuzumab)
Herceptin is a personalized medicine designed to specifically block the HER2 protein on the surface of some cancer cells. Based on preclinical studies, this biologic antibody is believed to work by attaching to HER2 receptors to stop signals that make the tumor cells grow and divide, and also by signaling the body’s immune system to destroy the cancer cells.
Herceptin Indication Statements
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:
- As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC→TH.”
- With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH.”
- Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
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:
- Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
- Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for 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:
- Fever and chills
- Feeling sick to your stomach (nausea)
- Throwing up (vomiting)
- Pain (in some cases at tumor sites)
- Headache
- Dizziness
- Shortness of breath
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 for seven months after a patient’s last dose of Herceptin. If a patient is or becomes pregnant while receiving Herceptin or within seven months after their last dose of Herceptin, the patient should immediately report Herceptin exposure to Genentech at (888) 835-2555.
Have any signs of SEVERE LUNG PROBLEMS, including:
- Severe shortness of breath
- Fluid in or around the lungs
- Weakening of the valve between the heart and the lungs
- Not enough oxygen in the body
- Swelling of the lungs
- Scarring of the lungs
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:
- Fever
- Feeling sick to your stomach (nausea)
- Throwing up (vomiting)
- Infusion reactions
- Diarrhea
- Infections
- Increased cough
- Headache
- Feeling tired
- Shortness of breath
- Rash
- Low white and red blood cell counts
- Muscle pain
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 Herceptin full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.herceptin.com.
About the FDC of Perjeta and Herceptin
The FDC of Perjeta and Herceptin is a new SC formulation that combines pertuzumab and trastuzumab with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Trastuzumab in the FDC is the same monoclonal antibody in IV Herceptin, and pertuzumab is the same monoclonal antibody in IV Perjeta. 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, dual blockade of the HER signaling pathways.
Halozyme’s Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.
About Kadcyla (ado-trastuzumab emtansine)
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells. It is designed to limit damage to healthy tissues, although it can still affect them. Kadcyla can cause serious side effects. It combines two anti-cancer agents using a stable linker: the HER2-targeting trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC approved for the treatment of HER2-positive metastatic breast cancer. In the U.S., Genentech licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
Important Safety Information
What is the most Important Safety Information I should know about KADCYLA?
Liver problems
- KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching
Heart problems
- KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat
Pregnancy
- Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive KADCYLA and for 7 months after your last dose of KADCYLA
- If you think you may be pregnant, you should contact your healthcare provider immediately
- If you are exposed to KADCYLA during pregnancy or if you become pregnant within 7 months following your last dose of KADCYLA, you are encouraged to report KADCYLA exposure to Genentech by calling 1-888-835-2555
- If you are a male patient with a female partner that could become pregnant, birth control should be used during treatment and for 4 months following your last dose of KADCYLA
- You should not breastfeed during treatment and for 7 months after the last dose of KADCYLA
Contact your doctor right away if you experience symptoms associated with these side effects.
What are the additional possible serious side effects of KADCYLA?
Lung problems
- KADCYLA may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs
Infusion-related reactions
- Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. Your doctor will monitor you for infusion-related reactions
Serious bleeding
- KADCYLA can cause life-threatening bleeding. Taking KADCYLA with other medications used to thin your blood (antiplatelet) or prevent blood clots (anticoagulation) can increase your risk of bleeding. Your doctor should provide additional monitoring if you are taking one of these other drugs while on KADCYLA. Even when blood thinners are not also being taken, life-threatening bleeding may occur with KADCYLA
Low platelet count
- Low platelet count may happen during treatment with KADCYLA.
Contacts
Media Contact:
Emmy Wang (650) 467-6800
Advocacy Contact:
Katie Creme Henry (650) 745-5210
Investor Contacts:
Loren Kalm (650) 225-3217
Karl Mahler 011 41 61 687 8503