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Genentech to Present New and Updated Data for Seven Approved and Investigational Medicines Across Multiple Types of Breast Cancer at the 2019 San Antonio Breast Cancer Symposium

November 18, 2019

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov 18, 2019--

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

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
9:30 – 9:45 AM CST

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
5:00 – 7:00 PM CST

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
5:00 – 7:00 PM CST

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
5:00 – 7:00 PM CST

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
5:00 – 7:00 PM CST

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
5:00 – 7:00 PM CST

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

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

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:

Important Safety Information

Side effects with Perjeta

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).

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

Other possible serious side effects

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 chemotherapy as part of an early breast cancer regimen before surgery are:

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:

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 H uman E pidermal growth factor R eceptor 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.

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 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:

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:

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

Heart problems

Pregnancy

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

Infusion-related reactions

Serious bleeding

Low platelet count

Nerve damage

Skin reactions around the infusion site

What are the most common side effects of KADCYLA?

The most common side effects in people taking KADCYLA for early breast cancer are:

The most common side effects seen in people taking KADCYLA for metastatic breast cancer are:

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Talk to a healthcare professional for more information about the benefits and risks of KADCYLA.

Please see full Prescribing Information for Important Safety Information, including Most Serious Side Effects.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indication (pronounced ‘tē-SEN-trik’)

What is Tecentriq?

Tecentriq is a prescription medicine used to treat adults with:

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

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:

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

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 when used in triple-negative breast cancer with paclitaxel protein-bound 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. 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. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Tecentriq.com for the Tecentriq full Prescribing Information for additional Important Safety Information.

About Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

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 and 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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SOURCE: Genentech

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PUB: 11/18/2019 01:00 AM/DISC: 11/18/2019 01:01 AM

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