Genentech, a member of the Roche Group, has presented the positive results from the first randomised Phase III study, designed to investigate HER2-targeted medicine Pertuzumab.
Pertuzumab, a humanised monoclonal antibody, is designed specifically to inhibit the binding of HER2 receptor from other HER receptors, resulting in suppression of cancer cell growth or the death of the cancer cell.
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The international randomised double-blind placebo-controlled Phase III clinical evaluation of pertuzumab and trastuzumab (CLEOPATRA) study involved 808 people with previously untreated HER2-positive metastatic breast cancer (mBC).
Participants in the Pertuzumab, herceptin and chemotherapy arm received Pertuzumab 840mg loading dose followed by 420mg every three weeks, herceptin 8mg/kg loading dose followed by 6mg/kg every three weeks, docetaxel 75-100mg/m² while participants in the Herceptin and chemotherapy arm received herceptin 8mg/kg loading dose followed by 6mg/kg every three weeks and docetaxel 75-100mg/m² every three weeks for six cycles or until progression.
The study evaluated the efficacy and safety profile of Pertuzumab in combination with Herceptin and docetaxel compared to Herceptin and docetaxel alone in patients with HER2-positive mBC.
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In the study, the primary endpoint includes progression-free survival (PFS), while the secondary endpoints are OS, PFS, safety profile, overall response rate (ORR), duration of response, time to symptom progression and correlation of biomarkers with clinical outcomes.
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By GlobalDataThe trial demonstrated a median PFS improved by 6.1 months from 12.4 months for Herceptin and chemotherapy to 18.5 months for Pertuzumab, Herceptin and chemotherapy.
Genentech Global Product Development head and chief medical officer Hal Barron said the study results support the ability of Herceptin plus chemotherapy in treating HER2-positive metastatic breast cancer.
"We have been studying the HER2 pathway for 30 years to bring personalised medicines to people with HER2-positive breast cancer," he added.
Preclinical studies showed that Herceptin attaches to HER2 receptors to stop signals that make the tumour cells grow and divide, and also by signaling the body’s immune system to destroy the cancer cells.
