New Treatment For Advanced HER2+ Breast Cancer Patients As Perjeta® (Pertuzumab) Gets Regulatory Green Light
From now on, patients with advanced HER2-positive breast cancer could benefit from the new personalised breast cancer treatment, Perjeta – which is now authorised for use in the UK. Perjeta has been granted a licence by the European Medicines Agency (EMA), for patients with previously untreated advanced HER2-positive breast cancer in combination with the current gold standard-of-care, Herceptin and chemotherapy (docetaxel).
This authorisation is based on data from the Phase III CLEOPATRA study, which showed that patients live on average 6.1 months longer without their cancer getting worse, compared with those receiving Herceptin and chemotherapy alone (primary endpoint, progression-free survival or ‘PFS’) (median PFS 18.5 vs. 12.4 months, HR=0.62, p<0.0001).[ii] Additionally, the combination of Perjeta plus Herceptin and chemotherapy reduces the risk of death by 34% (overall survival, HR=0.66; 95%, CI 0.52-0.84, p=0.0008)1 and more patients respond to the combination treatment compared with Herceptin and chemotherapy alone (80% compared with 69%, 95% CI, 4.2 to 17.5; p=0.0011).2
Perjeta maintains a quality of life comparable with Herceptin and chemotherapy in relation to the frequency of side effects. In the CLEOPATRA study, the combination of Perjeta, Herceptin and chemotherapy was associated with higher rates of diarrhoea (66.8% v. 46.3%), rash (33.7% v. 24.2%), mucosal inflammation (27.8% v. 19.9%), febrile neutropaenia (13.8% v. 7.6%) and dry skin (10.6% v. 4.3%).2 These side effects were primarily low grade (1 and 2), manageable and occurred during docetaxel therapy2d (which was administered for at least six cycles in the CLEOPATRA study).[iii] There was no increase in cardiac side effects or left ventricular systolic dysfunction (LVSD).2
“This license authorisation has been much anticipated and will be welcome news for patients with HER2-positive breast cancer in the UK,” said David Miles, Consultant Oncologist, Mount Vernon Cancer Centre, London. “Perjeta has been shown to extend survival and control cancer for longer than the current standard of care – showing a magnitude of benefit that has not been seen since the launch of Herceptin more than ten years ago. This marks a significant step forward in the treatment of this aggressive, difficult-to-treat disease.”
Roche looks forward to working with the National Institute of Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) to ensure patients and clinicians can routinely access Perjeta through the NHS. In the meantime, patients should be able to access Perjeta via the Cancer Drugs Fund (England), an Individual Patient Treatment Request (Scotland), an Individual Funding Request (Northern Ireland), Individual Patient Funding Request (Wales) or through some private health insurance.
Perjeta is the first in a new class of personalised treatments known as ‘HER2 dimerisation inhibitors’ (or ‘HDIs’) and works in a different way to any other cancer medicine. It works synergistically with Herceptin to block cancer cell survival and growth signals,[iv] specifically targeting the HER2 receptor – a protein found in high quantities on the surface of cells in HER2-positive breast cancers.
[i] Swain SM et al. (2012) Confirmatory overall survival analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled Phase III study with pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive first-line MBC. Poster P5-18-26 presented at SABCS; December 08 2012, San Antonio, Texas, USA
[ii] Baselga J. A Phase III, Randomized, Double-Blind, Placebo-Controlled Registration Trial to Evaluate the Efficacy and Safety of Placebo + Trastuzumab + Docetaxel vs. Pertuzumab + Trastuzumab + Docetaxel in Patients with Previously Untreated HER2-Positive Metastatic Breast Cancer (CLEOPATRA). Oral Presentation, SABCS 9th December abstract #S5-5
[iii]Perjeta® SmPC Roche Products Ltd. Perjeta® SmPC. March 2013
[iv]Baselga J, Swain SM. (2010) CLEOPATRA: A Phase III Evaluation of Pertuzumab and Trastuzumab for HER2-Positive Metastatic Breast Cancer. Clin Breast Cancer. Dec 1;10(6):489-91