Genentech, a member of the Roche Group, has reported clinical evaluation of pertuzumab and trastuzumab (CLEOPATRA) study data, which demonstrated that people with HER2-positive metastatic breast cancer (mBC) lived longer by taking Perjeta.
The phase III study randomly selected 808 people with HER2-positive mBC, which recurred after prior therapy in the adjuvant or neoadjuvant setting, to evaluate the efficacy and safety profile of Perjeta combined with Herceptin and docetaxel chemotherapy compared with Herceptin and chemotherapy plus a placebo.
The double-blind study demonstrated that the combination of Perjeta, Herceptin and docetaxel chemotherapy significantly improved overall survival, which is the secondary endpoint, in people with HER2-positive mBC, compared with Herceptin and chemotherapy.
Genentech global product development head and chief medical officer Hal Barron said that Perjeta helped people with HER2-positive metastatic breast cancer live longer and lengthened the time they lived without their disease worsening.
"The improvement in survival seen in the CLEOPATRA study is great news for patients and doctors; and reinforces our belief that Perjeta will improve the outlook for people with this devastating disease," Barron said.
The primary endpoint of the placebo-controlled study was progression-free survival (PFS), which demonstrated that people who received Perjeta in combination with Herceptin and docetaxel chemotherapy had a significant 38% reduction in the risk of their disease worsening or death compared with people who received Herceptin and chemotherapy plus a placebo.
The median PFS improved by just over six months from 12.4 months, for people who received Herceptin and chemotherapy plus placebo, to 18.5 months for those who received Perjeta, Herceptin and chemotherapy, according to the study data.
Common adverse reactions observed in the CLEOPATRA study were wiarrhoea, hair loss, low white blood cell count with or without fever, fatigue, rash and peripheral neuropathy (numbness, tingling or damage to the nerves).
Image: Genentech's Perjeta helped people with HER2-positive metastatic breast cancer live longer and lengthened the time they lived without their disease worsening. Photo: courtesy of Coolcaesar at en.wikipedia.