Phase III APHINITY Study Shows Genentech’s Perjeta® Regimen Helped People with an Aggressive Type of Early Breast Cancer Live Longer without their Disease Returning Compared to Herceptin® and Chemotherapy

-- Perjeta plus Herceptin and chemotherapy showed a statistically significant improvement in invasive disease-free survival (iDFS) for people with HER2-positive early breast cancer (EBC) compared to Herceptin and chemotherapy alone --
-- Data will be discussed with health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) --

SOUTH SAN FRANCISCO, CA, USA I March 1, 2017 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) today announced positive results from the Phase III APHINITY study. The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (EBC) compared to Herceptin and chemotherapy alone. The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, and no new safety signals were identified. Full results from the APHINITY trial will be presented at an upcoming medical meeting in 2017.

“These results from the positive APHINITY study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to discussing these adjuvant results with global regulatory authorities.”

Gunter von Minckwitz, M.D., study coordinator from the Breast International Group and academic study partners, added, “APHINITY provides yet another example of the importance of industry-academic collaborations and their value in advancing cancer care for people affected by this challenging disease.”

HER2-positive breast cancer is an aggressive form of the disease, which affects approximately one in five people with breast cancer and is associated with a poor prognosis if left untreated. Despite advancements in the treatment of HER2-positive EBC, up to one in three people treated with Herceptin and chemotherapy may eventually see their cancer return. Treatment options are needed to improve the outcomes of people with this aggressive disease. Treating breast cancer early, before it has spread, may improve the chance of preventing the disease from returning and potentially reaching an incurable stage. Adjuvant therapy is given after surgery and is aimed at killing any remaining cancer cells to reduce the risk of the cancer returning.

In the U.S., the combination of Perjeta, Herceptin and docetaxel chemotherapy is currently available under accelerated approval for neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin and docetaxel chemotherapy had no evidence of microscopic tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR) compared to almost 22 percent in the Herceptin and docetaxel chemotherapy arm. The APHINITY trial reflects the commitment to evaluate the Perjeta-based regimen as part of a complete treatment approach for EBC. These data will be discussed with the FDA with the hope to convert the current accelerated approval to a full approval.

About APHINITY

APHINITY (Adjuvant Pertuzumab andHerceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as an adjuvant therapy in 4,805 people with operable HER2-positive EBC.

People enrolled in the study underwent surgery and were randomized to one of two arms (1:1) to receive either:

   Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with Perjeta and Herceptin, followed by Perjeta and Herceptin every three weeks for a total of one year (52 weeks) of treatment.

   Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with placebo and Herceptin, followed by placebo and Herceptin every three weeks for a total of one year (52 weeks) of treatment.

Radiotherapy and/or endocrine therapy could be initiated at the end of adjuvant chemotherapy. The APHINITY study allowed for a range of standard chemotherapy regimens to be used and both lymph node-positive and lymph node-negative participants were eligible for enrollment. The primary efficacy endpoint of the APHINITY study is iDFS, which is the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life.

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, dual blockade of HER signaling pathways, thus preventing tumor cell growth and survival.

Perjeta Indication Statement

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.

   The safety of Perjeta in combination with doxorubicin-containing regimens has not been established.

   The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established.

Herceptin Indication Statements

Early Breast Cancer

Herceptin is approved for the treatment of early stage breast cancer that is 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-based therapy (a type of chemotherapy).

*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.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 255,180 people in the United States will be diagnosed with breast cancer, and 41,070 will die from the disease in 2017. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of tumor cells. This is known as “HER2 positivity” and affects approximately 15-20 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.

About Genentech in HER2-positive Breast Cancer

Genentech has spent more than 30 years studying the role of HER2 in cancer, and Perjeta is a result of this research. A diagnostic test is used to determine if a person’s tumor is HER2-positive and whether treatment with HER2-targeted medicines is appropriate.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.5 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more 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.

SOURCE: Genentech

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