Pressemelding -
CHMP recommends EU approval of Roche’s Perjeta® for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Basel, 27 April 2018
- In the large phase III APHINITY study, the combination of Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population
- In the study, the greatest risk reduction was observed in certain patients at high risk of recurrence
- Risk of recurrence or death was reduced by 23% in patients with lymph node-positive disease and by 24% in those with hormone receptor-negative disease
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future.
“The goal of treating early breast cancer is to provide the best chance for a cure. This is why we believe that building on the existing therapies is so vital,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s announcement brings hope that patients in Europe with HER2-positive early breast cancer, who are at a high risk of recurrence, will soon have a new treatment option to reduce the chance of their disease returning and potentially progressing to an incurable stage.”
The CHMP recommendation is based on results from a large phase III study (APHINITY) involving over 4,800 people with HER2-positive eBC.[1] At the time of the primary analysis, with a median follow-up of 45.4 months, the Perjeta-based regimen significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population (HR=0.81, 95% CI 0.66-1.00, p=0.045).1
The Perjeta-based regimen showed the greatest benefit in patients who are at high risk of recurrence:1
- For patients with lymph node-positive disease, the risk of recurrence or death was reduced by 23% with the Perjeta-based regimen (HR=0.77; 95% CI 0.62-0.96, p=0.019).
- Among patients with hormone receptor-negative disease, the Perjeta-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.085).
The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.1
Every year, almost 100,000 people in Europe are diagnosed with HER2-positive breast cancer, an aggressive type of the disease if left untreated.[2],[3],[4] The majority of breast cancer cases are diagnosed at an early stage where the goal of treatment is to cure.[5],[6] In the eBC setting, treatment may be given before surgery to shrink tumours and after surgery to help prevent the cancer from returning.[7],[8] Despite advances in the treatment of HER2-positive eBC, one in four people treated with Herceptin and chemotherapy will eventually see their cancer return in the long-term.[9] There is currently no cure for breast cancer that recurs and reaches an advanced stage and treatment for advanced disease is given to prolong life for as long as possible.[10]
For people diagnosed with HER2-positive eBC, the Perjeta-based regimen has already been approved for use before surgery in the EU, the US and many other countries.[11],[12]In December 2017, the US Food and Drug Administration (FDA) also approved the Perjeta-based regimen as a post-surgery treatment of HER2-positive eBC at high risk of recurrence.11 Patients in the US with HER2-positive eBC, eligible for the Perjeta-based regimen, should therefore receive Perjeta and Herceptin for 18 cycles, irrespective of the time of surgery, to complete one year of treatment.11
The combination has also been previously approved for the treatment of people with advanced HER2-positive breast cancer, where it has been shown to significantly extend survival compared to Herceptin and chemotherapy alone.11, 12 ,[13],
Perjeta works in combination with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor, thus preventing tumour cell growth and survival.[14]
For more information about HER2-positive breast cancer and the goals of treatment, visit our Breast Cancer Hub on roche.com.
About APHINITY1
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is invasive disease-free survival (iDFS), which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.
The following table is a summary of APHINITY study results supporting this approval.
| APHINITY study results1 Median follow-up for intent-to-treat (ITT) population 45.4 months (381 events) | ||
| Primary endpoint: invasive disease-free survival (iDFS) HR=0.81, 95% CI 0.66-1.00, p=0.045 | ||
| Perjeta + Herceptin + chemotherapy n=2,400 |
Placebo + Herceptin + chemotherapy n=2,404 | |
| iDFS at 3 years | ||
| ITT population n=4,804 | 94.1% 171 events | 93.2% 210 events |
| HR=0.81, 95% CI 0.66-1.00, p=0.045 | ||
| Node-positive subgroup† n=3,005 | 92.0% 139 events n=1,503 | 90.2% 181 events n=1,502 |
| HR=0.77, 95% CI 0.62-0.96 | ||
| Node-negative subgroup† n=1,799 | 97.5% 32 events n=897 | 98.4% 29 events n=902 |
| HR=1.13, 95% CI 0.68-1.86 | ||
| Hormone receptor-positive subgroup† n=3,082 | 94.8% 100 events n=1,536 | 94.4% 119 events n=1,546 |
| HR=0.86, 95% CI 0.66-1.13 | ||
| Hormone receptor-negative subgroup†n=1,722 | 92.8% 71 events n=864 | 91.2% 91 events n=858 |
| HR=0.76, 95% CI 0.56-1.04 | ||
| Anthracycline chemotherapy subgroup† n=3,742 | 93.8% 139 events n=1,865 | 93.0% 171 events n=1,877 |
| HR=0.82, 95% CI 0.66-1.03 | ||
| Non-anthracycline chemotherapy subgroup†n=1,062 | 94.9% 32 events n=535 | 94.0% 39 events n=527 |
| HR=0.82, 95% CI 0.51-1.31 | ||
| iDFS at 4 years^ | ||
| ITT population n=4,804 | 92.3% | 90.6% |
| Node-positive subgroup† n=3,005 | 89.9% | 86.7% |
| Node-negative subgroup† n=1,799 | 96.2% | 96.7% |
| Hormone receptor-positive subgroup† n=3,082 | 93.0% | 91.6% |
| Hormone receptor-negative subgroup†n=1,722 | 91.0% | 88.7% |
| Safety | ||
| Heart failure‡ | 0.6% | 0.2% |
| Most common (≥5%) severe (Grade 3-4) adverse events | ||
| Neutropenia Decrease in a certain type of white blood cell | 16.3% | 15.7% |
| Febrile neutropenia Fever associated with decrease in a certain type of white blood cell | 12.1% | 11.1% |
| Diarrhoea | 9.8% | 3.7% |
| Neutrophil count decreased Decrease in a certain type of white blood cell | 9.6% | 9.6% |
| Anaemia Decrease in red blood cells | 6.9% | 4.7% |
† Prespecified subgroup analyses without adjusting for multiple comparisons. Results are considered descriptive.
^ iDFS at four years was calculated based on data available at the time of primary analysis with median follow-up of 45.4 months.
‡Symptomatic heart failure (New York Heart Association class III or IV) with left ventricular ejection fraction (LVEF) drop ≥10% from baseline and to below 50%.
About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.[15],[16] Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.14,[17]
About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.2 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla® (trastuzumab emtansine).
Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.
References
[1] Minckwitz G, et al. N Engl J Med. 2017;377:122-31.
[2] Wolff AC, et al. J Clin Oncol. 2013;31(31):3997-4013.
[3] World Health Organization. Cancer Fact Sheets. [Internet; cited 2018 April 24]. Available from: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx.
[4] Dawood S, et al. J Clin Oncol. 2010;28(1):92-98.
[5] National Cancer Institute. Cancer Stat Facts: Female Breast Cancer. [Internet; cited 2018 April 24]. Available from: https://seer.cancer.gov/statfacts/html/breast.html.
[6] Scharl A, et al. Geburtshilfe Frauenheilkd. 2015;75(7):683-91.
[7] FDA 2014. Guidance for Industry: pCR in neoadjuvant treatment of high-risk eBC. [Internet; cited 2018 April 24]. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm305501.pdf.
[8] Johns Hopkins. Neoadjuvant and Adjuvant Chemotherapy. [Internet; cited 2018 April 24]. Available from: http://www.hopkinsmedicine.org/breast_center/treatments_services/medical_oncology/neoadjuvant_adjuvant_chemotherapy.html
[9] Slamon D, et al. BCIRG 006 trial. Presented at: SABCS; 2015 Dec 6-10; San Antonio, TX, USA. Abstract #S5-04.
[10] Cardoso F, et al. Ann Oncol. 2017;28(1):16-33.
[11] US Food and Drug Administration Prescribing Information for Perjeta. [Internet; cited 2018 April 24]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf.
[12] European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited 2018 April 24]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002547/WC500140980.pdf.
[13] Swain S, et al. N Engl J Med. 2015;372:724-34.
[14] Franklin M, et al. Cancer Cell. 2004;5(4):317-28.
[15] Lewis Phillips G, et al. Cancer Res. 2008;68:9280-90.
[16] Iqbal N and Iqbal N. Mol Biol Int. 2014;doi:10.1155/2014/852748.
[17] Baselga J and Swain S. Nat Rev. Cancer 2009;9(7):463-75.
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