Last updated on April 23, 2014 at 11:18 EDT

Roche’s Perjeta significantly extends survival in people with HER2-positive metastatic breast cancer

December 10, 2012

MISSISSAUGA, ON, Dec. 10, 2012 /CNW/ – Roche today announced updated
survival results from the Phase III CLEOPATRA study, which showed that
the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and
docetaxel chemotherapy significantly extended the lives (overall
survival) of people with previously untreated HER2-positive metastatic
breast cancer (mBC), compared to Herceptin, chemotherapy and
placebo. Results showed that the risk of death was reduced by 34
percent for people who received Perjeta, Herceptin and chemotherapy,
compared to those who received Herceptin and chemotherapy (HR=0.66;
p=0.0008). At the time of the analysis, median overall survival had not
yet been reached in people receiving the Perjeta combination, as more
than half of these people continued to survive. Median overall survival
was more than 3 years (37.6 months) for people who received Herceptin
and chemotherapy. Based on these data, people receiving Herceptin and
chemotherapy in CLEOPATRA have been offered the option to receive
Perjeta. No new safety signals were observed in the study.(1)

“The results of the CLEOPATRA study show that by adding Perjeta to
Herceptin and chemotherapy, it can significantly extend the lives of
many patients,” said Dr. Christine Brezden-Masley, Staff Medical
Oncologist, St. Michael’s Hospital, Toronto “This is an important
advancement in the development of targeted therapies and treatment for
HER2-positive metastatic breast cancer, a very aggressive form of the
disease. We hope that Perjeta will be made available to patients as
soon as possible.”

Perjeta is a personalised medicine that targets the HER2 receptor, a
protein found in high quantities on the outside of cancer cells in
HER2-positive cancers. Perjeta is believed to work in a way that is
complementary to Herceptin, as the two medicines target different
places on the HER2 receptor.

In June 2012, the U.S. Food and Drug Administration (FDA) approved
Perjeta in combination with Herceptin and docetaxel chemotherapy for
the treatment of people with HER2-positive mBC, who have not received
prior anti-HER2 therapy or chemotherapy for metastatic disease, based
on the results of the CLEOPATRA study.  Perjeta was approved by
Swissmedic in August 2012 and in Mexico in September 2012 for the
treatment of people with HER2-positive mBC who have not received prior
therapy for their metastatic disease. Roche has submitted a Marketing
Authorisation Application (MAA) to the European Medicines Agency (EMA)
for Perjeta for people with previously untreated HER2-positive
metastatic breast cancer.

These final, confirmatory survival data from the CLEOPATRA study will be
presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium
(SABCS; Abstract #P5-18-26, Friday 7th December 2012, 17:00-19:00 CDT
Exhibit Hall A-B) by Dr. Sandra Swain, Medstar Washington Hospital
Center, USA.

About the CLEOPATRA study

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind,
placebo-controlled study. The study evaluated the efficacy and safety
profile of Perjeta combined with Herceptin and docetaxel chemotherapy
compared to Herceptin and docetaxel chemotherapy plus placebo 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 neo-adjuvant setting.

The primary endpoint of the study was progression-free survival (PFS) as
assessed by an independent review committee. Secondary endpoints were
overall survival, PFS by investigator assessment, safety profile,
overall response rate (ORR), duration of response and time to symptom
progression. PFS and safety data from CLEOPATRA were presented at SABCS
2011 and simultaneously published in the New England Journal of Medicine.

Progression free survival and safety results

        --  People who received the combination of Perjeta, Herceptin and
            chemotherapy had a statistically significant 38 percent
            reduction in the risk of their disease worsening or death (PFS,
            HR=0.62, p-value=<0.0001) compared to people who received
            Herceptin, chemotherapy and placebo.2
        --  The median PFS improved by 6.1 months from 12.4 months for
            people who received Herceptin and chemotherapy to 18.5 months
            for those who received Perjeta, Herceptin and chemotherapy.2
        --  The most common adverse events (rate greater than 30 percent)
            seen with the combination of Perjeta, Herceptin and
            chemotherapy were diarrhoea, hair loss, low white blood cell
            count with or without fever, upset stomach, fatigue, rash and
            peripheral neuropathy (numbness, tingling or damage to the
            nerves).  The most common Grade 3-4 adverse events (rate
            greater than 2 percent) were low white blood cell count with or
            without fever, decrease in a certain type of white blood cell,
            diarrhoea, damage to the nerves, decrease in red blood cell
            count, weakness and fatigue).2

About Perjeta

Perjeta is designed specifically to prevent the HER2 receptor from
pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and
HER4) on the surface of cells, a process that is believed to play a
role in tumour 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, Herceptin and docetaxel
chemotherapy is thought to provide a more comprehensive blockade of HER
signalling pathways.

Roche has 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 Herceptin

Herceptin is a humanised monoclonal antibody, designed to target and
block the function of HER2, a protein produced by a specific gene with
cancer-causing potential when it is overexpressed. The mode of action
of Herceptin is unique in that it activates the body’s immune system
and suppresses HER2 signalling to target and destroy the tumour.
Herceptin has demonstrated unprecedented efficacy in treating both
early and advanced (metastatic) HER2-positive breast cancer. Given on
its own as monotherapy as well as in combination with or following
standard chemotherapy, Herceptin has been shown to improve overall
survival, response rates and disease-free survival while maintaining
quality of life in women with HER2-positive breast cancer. Herceptin is
marketed in the United States by Genentech, in Japan by Chugai and
internationally by Roche. Since 1998, Herceptin has been used to treat
more than 1.2 million people with HER2-positive breast cancer

About breast cancer

Breast cancer is the most common cancer among women worldwide.(3) Each year about 1.4 million new cases of breast cancer are diagnosed
worldwide, and over 450,000 women will die of the disease annually.(3)  In HER2-positive breast cancer, increased quantities of the human
epidermal growth factor receptor 2 (HER2) are present on the surface of
the tumour cells. This is known as “HER2 positivity” and affects
approximately 15-20 percent of women with breast cancer(4) HER2-positive cancer is a particularly aggressive form of breast

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals
and diagnostics. Roche is the world’s largest biotech company with
truly differentiated medicines in oncology, virology, inflammation,
metabolism and CNS. Roche is also the world leader in in-vitro
diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes
management. Roche’s personalized healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the
health, quality of life and survival of patients. In 2011, Roche had
over 80,000 employees worldwide and invested over 8 billion Swiss
francs in R&D. The Group posted sales of 42.5 billion Swiss francs.
Genentech, United States, is a wholly owned member of the Roche Group.
Roche has a majority stake in Chugai Pharmaceutical, Japan. For more
information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information

Roche in Oncology: www.roche.com/de/media/media_backgrounder/media_oncology.htm


      1. Swain S, et al. Confirmatory overall survival analysis of
         CLEOPATRA: A randomized, double-blind, placebo-controlled Phase
         III study with pertuzumab, trastuzumab, and docetaxel in patients
         with HER2-positive first-line metastatic breast cancer. Poster
         presentation at the 2012 CTRC-AACR San Antonio Breast Cancer
         Symposium. Abstract # P5-18-26.
      2. Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus
         trastuzumab plus docetaxel for metastatic breast cancer.  N Engl J
         Med 2012; 366:109-19.
      3. Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM
         GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC
         Cancer Base # 10 [Internet]. Lyon, France: International Agency
         for Research on Cancer; 2010. Available from:


      4. Wolff A.C et al. American Society of Clinical Oncology/ College of
         American Pathologists Guideline Recommendations for Human
         Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch
         Pathol Lab Med 2007; 131: 18-34.
      5. Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast
         Cancer. N Engl J Med 2011; 365:1273-83.

SOURCE Roche Canada

Source: PR Newswire