LYNPARZA (OLAPARIB) ACCEPTED FOR USE IN SCOTLAND AS ADJUVANT TREATMENT FOR PATIENTS WITH GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER
London, UK, Monday 9 October 2023 – AstraZeneca today announced that Lynparza (olaparib) has been accepted for use within NHS Scotland by the Scottish Medicines Consortium (SMC) for use as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.1
Almost 56,000 people are diagnosed with breast cancer per year in the UK, around 150 per day, with nearly 5,000 of these occurring in Scotland.[4],[5] Roughly 90% of all breast cancer patients are diagnosed at an early stage of disease (stage I-IIIA) and BRCA mutations are found in approximately 5% of patients.[6],[7] Despite breast cancer survival improving, one in three women may still experience a recurrence.[8],[9] When the cancer recurs, it is incurable.[10]
Professor David Cameron, Professor of Oncology at Edinburgh University and Director of Cancer Services at NHS Lothian, said: “Olaparib demonstrated significant survival benefit in the global OlympiA Phase III trial, run as a successful partnership between academia and AstraZeneca. Olaparib offers more hope to those women with a mutation in a BRCA gene and living with breast cancer in Scotland. Today’s decision by the SMC means that olaparib is now the only approved treatment specifically targeting BRCA mutations in early breast cancer (stage I-IIIA) in Scotland and has the potential to transform patient outcomes by improving survival and preventing the cancer from coming back.”
Tom Keith-Roach, President, AstraZeneca UK, said: “It is paramount that patients in Scotland have access to BRCA testing to determine whether olaparib is an appropriate treatment option. We look forward to working with NHS Scotland to make this happen as quickly as possible. Today’s welcome approval brings us one step closer towards our long-term ambition of eliminating cancer as a cause of death in the UK.”
Today’s decision from the SMC is based on results from the OlympiA Phase III trial. In the primary endpoint of the trial, there was a statistically significant and clinically meaningful improvement in three-year invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second primary invasive cancers or death, by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.001).2
In one secondary endpoint of the OlympiA trial, data also showed that olaparib demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 32% versus placebo (based on a HR of 0.68 (99% CI: 0.44 to 1.05) p=0.02).2 The safety and tolerability profile of olaparib in this trial was in line with that observed in prior clinical trials.[11]
Across the OlympiA Phase III trial, the most common adverse reactions in the olaparib treatment arm (n=911) included: nausea (56.9% all grades; 0.8% > grade 3), fatigue (40.1% all grades; 1.8% > grade 3), anaemia (23.5% all grades; 8.7% > grade 3), vomiting (22.6% all grades; 0.7% > grade 3), headache (19.8% all grades; 0.2% > grade 3), diarrhoea (17.6% all grades; 0.3% > grade 3), decreased neutrophil count (16.0% all grades; 4.8% > grade 3), decreased white cell count (15.7% all grades; 3.0% > grade 3), decreased appetite (13.1% all grades; 0.2% > grade 3), dysgeusia (11.7% all grades; 0% > grade 3), dizziness (11.4% all grades; 0.1% > grade 3), arthralgia (9.2% all grades; 0.2% > grade 3).2
[4] Cancer Research UK. Breast cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Zero Last accessed October 2023.
[5] Breast Cancer Now. Breast cancer facts and statistics. Available at: https://breastcancernow.org/about-us/why-we-do-it/breast-cancer-facts-and-statistics/ Last accessed October 2023.
[6] Cardoso F, et al. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Annals of Oncology. 2012;23:vii11-9.
[7] Peto J, Collins N, Barfoot R, et al. Prevalence of BRCA1 and BRCA2 Gene Mutations in Patients With Early-Onset Breast Cancer. JNCI. 1999;91;11:943-949.
[8] Colleoni M, et al. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. Journal of Clinical Oncology. 2016;9:927-35.
[9] Riggio AI, et al. The lingering mysteries of metastatic recurrence in breast cancer. British Journal of Cancer. 2021;124:13–26.
[10] Breast Cancer Now. Breast cancer recurrence. Available at: https://breastcancernow.org/information-support/facing-breast-cancer/diagnosed-breast-cancer/your-primary-cancer-has-come-back-recurrence. Last accessed: October 2023.
[11] Geyer CE Jr, Garber JE, Gelber RD, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33(12):1250-1268.
