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Perjeta® gets regulatory green light for use in early HER2-positive breast cancer prior to surgery

Over 1800 women per year in the UK with an aggressive type of breast cancer could benefit from Perjeta (pertuzumab) as a targeted neo-adjuvant (pre-surgery) treatment for HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence. Perjeta is licensed for use in combination with current treatment Herceptin® (trastuzumab) and chemotherapy.

The authorisation is based on data from two key studies, including NEOSPHERE, which showed that the Perjeta regimen nearly doubled the number of women whose tumours were eradicated compared with current treatment (measured by pathological complete response (pCR), defined as the absence of invasive tumour tissue at the time of surgery in the affected breast and lymph nodes; 39.3 versus 21.5%). Additional data showed that patients were 40% more likely to be disease-free after three years versus current treatment (measured by disease-free survival/DFS: HR=0.60; 95% CI, 0.28–1.27. DFS results are descriptive only as the study was not designed to show statistical significance for three-year DFS). The Perjeta regimen is the first neo-adjuvant breast cancer treatment authorised in the EU based on the benefit in achieving pCR.

Dr Andrew Wardley, Consultant in Medical Oncology at The Christie NHS Foundation Trust and one of the British doctors involved in trials of the medicine, said: “Therapy for breast cancer has the greatest impact in the early stage, where it can prevent the cancer from returning or spreading and eradicate the cancer in some cases. The ability to do this is associated with pathological complete response, which is greatly increased with the addition of pertuzumab, to existing treatments before surgery. The extent of surgery can also be reduced if response to treatment is very good. There is a need to bring effective medicines to patients with cancer earlier. Perjeta has already shown the longest survival benefit in patients with previously untreated advanced HER2-positive breast cancer, so it is very encouraging to see its authorisation in an earlier setting in order to further improve the long-term outcomes for patients with this aggressive disease.

David Harland, HER2 Country Medical Lead, Roche Products Limited, commented: “Roche has been leading research into the HER2 pathway for more than 30 years and we are proud of our achievements to date. We are pleased that the use of pathological complete response as a novel clinical trial endpoint and the benefits seen by patients has enabled the authorisation of Perjeta in an early pre-surgery setting. What is important now is that patients can access this medicine via the NHS as soon as possible – including in its advanced indication, which has still yet to receive a NICE final appraisal, despite being submitted over two years ago. This highlights a very real sense of urgency to work together to protect the interests of patients needing treatment now.

The safety profile of Perjeta was consistent in the primary analysis of the NEOSPHERE study as well as with previous studies of Perjeta, including TRYPHAENA, which also supported the authorisation. No new safety signals were identified. The most common side effects experienced by patients taking the combination of Perjeta, Herceptin and chemotherapy in NEOSPHERE were neutropenia (44.9%), febrile neutropenia (8.4%) and leukopenia (4.7%).

Perjeta is the first in a 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, specifically targeting the HER2 receptor – a protein found in high quantities on the surface of cells in HER2-positive breast cancers.

Roche will be working with NHS England, the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) to ensure clinicians can prescribe Perjeta routinely through the NHS. The medicine is available to patients with previously untreated advanced disease through the Cancer Drugs Fund (CDF) but is not currently listed on the CDF in the early indication.