Friday, December 7, 2012

Perjeta extends Median Overall Survival in patients with HER2+ve metastatic breast cancer

Roche 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.


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=".0001" and="and" br="br" chemotherapy="chemotherapy" compared="compared" herceptin="herceptin" people="people" placebo.="placebo." received="received" to="to" who="who">• 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.
• 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).








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