- Final data from Phase III CLEOPATRA study showed people with previously untreated HER2-positive metastatic breast cancer who received Perjeta, Herceptin and docetaxel chemotherapy lived a median of 56.5 months compared to 40.8 months for people who received Herceptin and chemotherapy
- Median overall survival of almost five years is the longest observed to date in people with this aggressive type of advanced breast cancer
SOUTH SAN FRANCISCO, CA, USA I September 28, 2014 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced final survival results from the Phase III CLEOPATRA study, which showed that adding Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer (MBC) by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months). No new safety signals were observed in the study. These data will be presented today in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2014 congress in Madrid, Spain (Abstract #350O_PR; Sunday, September 28, 4:00-5:30 p.m. CEST) and are also featured in the official ESMO Press Briefing.
“Adding Perjeta to treatment with Herceptin and chemotherapy resulted in the longest survival observed to date in a clinical study of people with HER2-positive metastatic breast cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The median survival of nearly five years for people who received the Perjeta regimen is 15.7 months longer than for people who received Herceptin and chemotherapy alone, a magnitude of improvement we rarely see in clinical trials in advanced cancer.”
Perjeta in combination with Herceptin and docetaxel chemotherapy is approved in the United States and the European Union for people with previously untreated HER2-positive MBC.
About the CLEOPATRA Study
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) was an international, Phase III, randomized, double-blind, placebo-controlled study. The study compared the combination of Perjeta, Herceptin and docetaxel chemotherapy with placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive MBC, or with HER2-positive MBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included OS and safety profile.
An interim OS analysis from the CLEOPATRA study was previously presented at the San Antonio Breast Cancer Symposium (SABCS) in 2012. At the time of the analysis, median OS had not yet been reached for people receiving the Perjeta regimen as more than half of these people continued to survive. The results to be presented today are from the final pre-specified OS analysis after a median follow-up of 50 months; median OS has now been reached for people receiving the Perjeta regimen. These data will be submitted to regulatory authorities around the world for inclusion in the prescribing information for Perjeta. The safety profile of Perjeta in this analysis was consistent with that observed previously in the CLEOPATRA study, including Perjeta’s long-term cardiac safety. No new safety signals were observed.
Updates to previously reported OS, PFS and safety profile data from the CLEOPATRA study will also be presented today. These data showed:
- The risk of death was reduced by 32 percent for people who received the Perjeta regimen, compared to those who received Herceptin and chemotherapy (hazard ratio [HR]=0.68, 95 percent CI 0.56-0.84; p=0.0002).
- People who received the Perjeta regimen had a 32 percent reduction in the risk of their disease worsening or death (PFS; HR=0.68, 95 percent CI 0.58-0.80) compared to people who received Herceptin and chemotherapy.
- With longer follow-up, the median PFS improvement of more than six months was maintained (median PFS of 18.7 months for people who received Perjeta, Herceptin and chemotherapy compared to 12.4 months for those who received Herceptin and chemotherapy).
- The most common adverse events (AEs, rate greater than 50 percent or greater than 5 percent difference between study groups) seen with the Perjeta regimen were hair loss, diarrhea, low white blood cell count, rash, mucosal inflammation, headache, upper respiratory tract infection, itching, low white blood cell count with fever, dry skin and muscle spasms.
- The most common Grade 3-4 AEs (rate greater than 10 percent) were low white blood cell count, low white blood cell count with fever and a decrease in a certain type of white blood cell.
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.
Perjeta Indication Statement
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.
Important Safety Information
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.
Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.
- Patients who think they may be pregnant should contact their healthcare provider immediately.
- If patients are exposed to Perjeta during pregnancy, they are 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
- 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.
- 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.
Most Common Side Effects
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)
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 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 235,000 people in the United States will be diagnosed with breast cancer, and 40,000 will die from the disease in 2014. 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 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.
About Genentech and Roche in HER2-positive Breast Cancer
Genentech and Roche have spent more than 30 years studying the role of HER2 in cancer, and Perjeta is a result of this research. A companion diagnostic test is used to determine if a person is HER2-positive and whether treatment with Perjeta and Herceptin 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 300 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 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 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.
SOURCE: Genentech
