The European Medicines Agency (EMA) has approved Roche's Perjeta (pertuzumab) for use in combination with Herceptin (trastuzumab) and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
Perjeta prevents the HER2 receptor from pairing (dimerising) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that plays a role in tumour growth and survival.
The approval was based on positive results from the company's international, randomised, double-blind, placebo-controlled Phase III study, which had enrolled 808 patients with previously untreated HER2-positive metastatic breast cancer or that had returned after prior therapy in the adjuvant (after surgery) or neoadjuvant (before surgery) setting.
The trial, clinical evaluation of pertuzumab and trastuzumab (CLEOPATRA), compared the efficacy and safety profile of Perjeta combined with Herceptin and docetaxel chemotherapy to Herceptin and chemotherapy plus placebo.
The study met its primary endpoint of progression-free survival and secondary endpoint of overall survival.
The risk of death was reduced to 34% in patients who received the combination of Perjeta, Herceptin and chemotherapy compared to those who received Herceptin and chemotherapy (overall survival, HR=0.66; p=0.0008).
In study patients receiving the combination of Perjeta, Herceptin and chemotherapy, the most common adverse reactions (rate greater than 30%) included diarrhoea, hair loss, low white blood cell count with or without fever, upset stomach, fatigue, rash and peripheral neuropathy.