Roche announced results from the Phase 3 CLEOPATRA study evaluating the addition of Perjeta (pertuzumab; Genentech) to Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer (mBC).
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) was an international, randomized, double-blind, placebo-controlled study evaluating 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).
Results demonstrated that:
- The risk of death was reduced by 32% for people who received the Perjeta regimen compared to those who received Herceptin and chemotherapy (HR=0.68, 95%CI 0.56–0.84; P=0.0002).
- People who received the Perjeta regimen had a 32% reduction in the risk of their disease worsening or death (PFS; HR=0.68, 95% 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).
- Addition of Perjeta to Herceptin 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).
Perjeta in combination with Herceptin and docetaxel chemotherapy is already approved for patients with previously untreated HER2-positive mBC. The Perjeta regimen has also been granted accelerated approval as a neoadjuvant treatment for HER2-positive early breast cancer (eBC) by the Food and Drug Administration.
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