INNOVATIVE ACCESS DEAL SECURED IN THE UK FOR LYNPARZA (OLAPARIB) TO TREAT BRCA-MUTATED CANCERS

INNOVATIVE ACCESS DEAL SECURED IN THE UK FOR LYNPARZA (OLAPARIB) TO TREAT BRCA-MUTATED CANCERS

• Olaparib is the first and only treatment available within NHS England for patients with germline BRCA mutations in early breast cancer (stage I-IIIA) and patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1 or BRCA2 mutations.^[1],[2]
• AstraZeneca has reached a landmark agreement with NHS England to enable routine availability of olaparib, resulting in two positive NICE recommendations.^1,2
• Cancer cells with BRCA mutations are highly sensitive to PARP inhibition.^[3] Olaparib works by inhibiting PARP proteins to disrupt the DNA-repair process and without these proteins, cancer cells may become too damaged to survive and die.³

London, UK, Thursday 6 April 2023 – AstraZeneca today announced that a landmark agreement with NHS England for Lynparza (olaparib) has enabled two positive recommendations from the National Institute for Health and Care Excellence (NICE). Olaparib will be routinely available as a treatment for germline BRCA-mutated HER2-negative high-risk early-stage breast cancer and metastatic castration-resistant prostate cancer (mCRPC) with germline and somatic BRCA1 or BRCA2 mutations.^1,2

Tom Keith-Roach, President, AstraZeneca UK, said: “This is a hard-won and extremely important milestone agreement with NHS England, which follows on from the successful NICE health technology assessment process. Innovative oncology medicines such as olaparib often show effectiveness across multiple different cancer types and, in these situations, it’s essential that we continue to advance pricing and reimbursement pathways which support rapid and appropriate patient access.”

David Brocklehurst, Head of Oncology, AstraZeneca UK, said: “We know how devastating a diagnosis of either of these hard-to-treat, aggressive cancers can be, for patients and their loved ones. Until now, treatment options for breast and prostate cancers resulting from BRCA mutations have been extremely limited. The availability of olaparib, a treatment discovered and developed in the UK, makes us extremely proud. Treatment innovations such as these underscore our bold long-term ambition to eliminate cancer as a cause of death.”

Olaparib in breast cancer

Almost 56,000 people are diagnosed with breast cancer per year in the UK, around 150 per day, accounting for 15% of all cancer cases.^[4] Roughly 90% of all breast cancer patients are diagnosed at an early stage of the disease (stage I-IIIA)^[5] and BRCA mutations are found in approximately 5% of patients.^[6] Despite breast cancer survival improving, one in three women may still experience a recurrence.^[7],[8] When this cancer recurs, it is incurable.^[9] NICE has today issued a recommendation for the use of olaparib (alone or with endocrine therapy), within its marketing authorisation, as an option for the adjuvant treatment of HER2-negative high-risk early breast cancer that has been treated with neoadjuvant or adjuvant chemotherapy in adults with germline BRCA1 or 2 mutations.¹

Dr Stuart McIntosh, Clinical Reader at The Patrick G Johnston Centre for Cancer Research, Queen’s University & Consultant Breast Surgeon, said: “As the first targeted treatment to block DNA damage response in germline BRCA tumours, today’s approval of olaparib is extremely welcome news for eligible patients and the wider oncology community. This is a significant step forward for patients with a specific inherited form of high-risk early breast cancer (stage I-IIIA) caused by mutations in the BRCA1 and BRCA2 genes where there is a high risk of cancer recurring, following chemotherapy.”

Olaparib in prostate cancer

In the UK, more than 52,000 men are diagnosed with prostate cancer every year, accounting for more than 140 cases per day.^[10] Metastatic castration-resistant prostate cancer (mCRPC) is a type of advanced, hard-to-treat cancer which has spread to other parts of the body and has evolved a resistance to hormone therapy.^[11] Around one in 10 men with mCRPC could have a BRCA1 or BRCA2 mutation in their tumour, detected through a genomic test performed on tissue and/or blood.^[12] NICE has today issued a recommendation for the use of olaparib, within its marketing authorisation, as an option for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) in adults.²

Professor Johann De Bono, Professor in Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Today’s positive recommendation by NICE is a huge step forward for patients with this aggressive and incurable type of prostate cancer. I’m delighted to see the NHS in England and Wales align with NHS Scotland, where olaparib is already available for patients with this specific tumour type. Olaparib is the perfect example of how understanding the underlying genetics of patients and their tumours can be used to design highly targeted precision medicines. It is imperative that all patients with metastatic castration-resistant prostate cancer are tested for BRCA mutations as soon as possible following diagnosis to maximise the number of people who can benefit from this treatment.”

The safety and tolerability data from the OlympiA and PROfound Phase III trials in early breast cancer (stage I-IIIA) and metastatic castration-resistant prostate cancer (mCRPC) with BRCA1 or BRCA2 mutations were consistent with the known profile of the medicine.^[13],[14]

[1] National Institute for Health and Care Excellence. Final Appraisal Document. Lynparza (olaparib) for adjuvant treatment of BRCA mutation-positive HER2-negative high-risk early breast cancer after chemotherapy.

Issue date: 6 April 2023.

[2] National Institute for Health and Care Excellence. Final Appraisal Document. Lynparza (olaparib) for treatment of previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer. Issue date: 6 April 2023.

[3] Chen A. PARP inhibitors: its role in treatment of cancer. Chin J Cancer. 2011;30(7):463-471.

[4] Breast Cancer UK. Facts and Figures. Available at: https://www.breastcanceruk.org.uk/about-breast-cancer/facts-figures-and-qas/facts-and-figures/. Last accessed: April 2023.

[5] 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.

[6] 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.

[7] 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.

[8] Riggio AI, et al. The lingering mysteries of metastatic recurrence in breast cancer. British Journal of Cancer. 2021;124:13–26.

[9] 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: April 2023.

[10] About Prostate Cancer. Prostate Cancer UK. Available at: https://prostatecanceruk.org/prostate-information/about-prostate-cancer. Last accessed: April 2023.

[11] Moreira D et al. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017, 15(1), pp. 60-66.e2.

[12] de Bono J et al. Central, prospective detection of homologous recombination repair gene alterations in tumour tissue from >4000 men with metastatic castration-resistant prostate cancer screened for the PROfound study. Poster 847PD. Presented at ESMO Annual Meeting, 27 September–1 October 2019, Barcelona, Spain.

[13] 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.

[14] De Bono J et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020; 382:2091-2102.