Genentech’s Perjeta Regimen Helped People With HER2-Positive Early Breast Cancer Live Longer Without Their Disease Returning Or Getting Worse Compared To Herceptin And Chemotherapy

CHICAGO--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new results from the Phase II NeoSphere study. The results suggested that Perjeta^® (pertuzumab) in combination with Herceptin^® (trastuzumab) and docetaxel chemotherapy given prior to surgery reduced the risk of disease getting worse and increased the time people lived without their cancer returning compared to Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). The safety profile of the Perjeta regimen was consistent with that seen in previous studies, and no new safety signals were identified. These data will be presented today at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Dr. Luca Gianni, Medical Oncology, San Raffaele Hospital, Scientific Institute (Abstract #505).

“These new results add to the body of data for Perjeta in the neoadjuvant setting, and we look forward to the Phase III APHINITY study results to better understand the broader impact of Perjeta in the adjuvant treatment of HER2-positive early breast cancer.”

In the NeoSphere study, both progression-free survival (PFS) and disease-free survival (DFS) were evaluated at three years. The results suggested that people who received the Perjeta regimen prior to surgery were 31 percent less likely to experience disease worsening, recurrence or death (PFS HR=0.69; 95% CI, 0.34–1.40) compared to those who received Herceptin and chemotherapy. People treated with the Perjeta regimen were also 40 percent less likely to experience disease recurrence or death (DFS HR=0.60; 95% CI, 0.28–1.27). People in the NeoSphere study who were treated in the neoadjuvant setting also received a year of adjuvant treatment with Herceptin plus chemotherapy after their surgery. The results of this analysis are descriptive, as the study was not designed to show statistical significance for three-year PFS and DFS.

“Treating breast cancer early, before it has spread, may help prevent the disease from returning or reaching an advanced stage,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These new results add to the body of data for Perjeta in the neoadjuvant setting, and we look forward to the Phase III APHINITY study results to better understand the broader impact of Perjeta in the adjuvant treatment of HER2-positive early breast cancer.”

The results also suggested that people who achieved pathological complete response (pCR; no tumor tissue detectable at the time of surgery in the affected breast and local lymph nodes) were more likely across all arms of the study to be alive and disease-free at three years (PFS HR=0.54; 95% CI, 0.29–1.00; DFS HR=0.68; 95% CI, 0.36–1.26). It was previously reported that the Perjeta regimen significantly increased the number of people who achieved pCR compared to Herceptin and docetaxel chemotherapy (39.3 vs. 21.5 percent).

In 2013, the U.S. Food and Drug Administration (FDA) granted accelerated (or “conditional”) approval of the Perjeta regimen for neoadjuvant treatment in people with high-risk, HER2-positive eBC. A full review of data from the ongoing Phase III APHINITY study will be required for the accelerated approval to be converted to a full approval. APHINITY compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment in people with HER2-positive eBC. Data from APHINITY are expected in 2016.

Roche recently submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for the Perjeta regimen as a neoadjuvant treatment for people with HER2-positive eBC.

About the NeoSphere Trial

The NeoSphere trial (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation) is a randomized, multicenter, international Phase II study in 417 people with newly diagnosed HER2-positive, operable, locally advanced, or inflammatory eBC. Participants were randomized to one of four study arms and received four cycles (12 weeks) of neoadjuvant treatment followed by surgery and a year of adjuvant treatment with Herceptin plus chemotherapy. The primary endpoint was pCR. Secondary endpoints included clinical response, time to clinical response, safety profile, PFS, DFS, breast-conserving surgery rate and biomarker assessment.

These new data suggested:

• PFS rate at three years was 90 percent in the Perjeta arm compared to 86 percent in the Herceptin and docetaxel chemotherapy arm (HR=0.69).
• DFS rate was 92 percent in people who received the Perjeta regimen compared to 85 percent in people who received Herceptin and chemotherapy (HR=0.60).
• The safety profile was consistent with previous studies of Perjeta, and no new safety signals were identified.

Previously reported data from the primary analysis showed:

• Treatment with Perjeta, Herceptin and docetaxel chemotherapy significantly improved the rate of pCR in the affected breast and local lymph nodes by 17.8 percent compared to Herceptin and chemotherapy alone (39.3 vs. 21.5 percent, p=0.0063).
• pCR of 21.5 percent for Herceptin and chemotherapy
• pCR of 39.3 percent for Perjeta, Herceptin and chemotherapy
• pCR of 11.2 percent for Perjeta and Herceptin
• pCR of 17.7 percent for Perjeta and chemotherapy
• The Perjeta regimen was not associated with a significant increase in adverse events (AEs), compared to Herceptin and chemotherapy alone.
• The most common severe (Grade 3 or higher) AEs for the Perjeta regimen were neutropenia (decrease in a certain type of white blood cell, 44.9 percent), febrile neutropenia (fever associated with decrease in a certain type of white blood cell, 8.4 percent), leukopenia (decrease in overall white blood cells, 4.7 percent) and diarrhea (5.6 percent).

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

Perjeta Indication Statements

Perjeta is approved for use in combination with Herceptin and docetaxel chemotherapy 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 people who had no evidence of cancer in the breast or lymph nodes at the time of surgery. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta as part of a doxorubicin (chemotherapy)-containing regimen has not been established. The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established.

Important Safety Information

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, the doctor may decide to hold or discontinue treatment with Perjeta.

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, the patient should talk with her doctor about either stopping breastfeeding or stopping Perjeta.
• If a patient thinks she may be pregnant, the patient should contact their healthcare provider immediately.
• If a patient is exposed to Perjeta 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.

Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.

Other possible serious side effects of Perjeta therapy include:

• Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving Perjeta, Herceptin and docetaxel chemotherapy 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. This reaction may be severe, may happen quickly and may affect many areas of the body.

Perjeta has only been shown to work in people with HER2-positive breast cancer.

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy 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 a 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 docetaxel chemotherapy as part of an early stage breast cancer regimen before surgery are:

• Hair loss
• Diarrhea
• Nausea
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy following three cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early stage breast cancer regimen before surgery are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever

The most common side effects of Perjeta when given with Herceptin, docetaxel chemotherapy and carboplatin chemotherapy as part of an early stage breast cancer regimen before surgery are:

• Feeling tired
• Hair loss
• Diarrhea
• Nausea
• Vomiting
• Low levels of white blood cells with or without a fever
• Low platelet count
• Low levels of red blood cells

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 Perjeta full Prescribing Information including Most Serious Side Effects for additional Important Safety Information at http://www.perjeta.com.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 234,000 people in the United States will be diagnosed with breast cancer, and 41,000 will die from the disease in 2015. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 20-25 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 and Kadcyla are 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

Founded more than 35 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.