PATIENTS IN SCOTLAND WITH AN ADVANCED FORM OF PROSTATE CANCER CAN NOW ACCESS LYNPARZA (OLAPARIB) WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE WITHOUT A BIOMARKER TEST

• Olaparib with abiraterone and prednisone or prednisolone becomes the first and only combination therapy to be accepted for use in Scotland for adult patients with metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated, regardless of biomarker status.[1]
• Acceptance by the Scottish Medicines Consortium (SMC) is based on pivotal data from the PROpel Phase III trial which illustrated olaparib as the first PARP inhibitor in combination with abiraterone and prednisone or prednisolone to reduce the risk of disease progression or death by more than a third (34%) in this setting.[2]
• Safety and tolerability was in line with prior clinical trials and the known profiles of the individual medicines.²
• Prostate cancer is the most common cancer among Scottish males, affecting 1 in 10 men.[3] Around 10-20% of patients with advanced prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years and at least 84% of these patients will have metastases at the time of CRPC diagnosis.[4]

London, UK, Monday 11 March 2024 – AstraZeneca and MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA [NYSE: MRK]) today announced that the Scottish Medicines Consortium (SMC) has accepted Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone for adult patients with metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated, regardless of biomarker status.¹

Prostate cancer is the most common cancer among Scottish males, affecting 1 in 10 men.³ Approximately 10-20% of these can be classified as castration resistant (CRPC), evolving to resist the standard of care (SOC), androgen deprivation therapy (ADT).⁴ When CRPC is at an advanced or metastasised stage (mCRPC), meaning it has spread to other parts of the body, it is typically hard to treat, resulting in a poor prognosis.[5]^,[6]

Professor Robert Jones, Professor of Clinical Cancer Research, University of Glasgow, said:

“Currently there is no cure for advanced prostate cancer which often leads to poor prognosis. This acceptance by the SMC marks a milestone for men living with this specific type of prostate cancer as pivotal data from the PROpel Phase III trial have shown that olaparib combination therapy significantly reduced the risk of disease progression compared to placebo and abiraterone.”

Roughly half of patients with mCRPC only ever receive one line of therapy and there is an urgent unmet need for new treatments in the first-line treatment of mCRPC to optimise patient outcomes.[7] 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.[8]

This SMC acceptance is based on pivotal data from the PROpel Phase III clinical trial.² In the planned primary analysis of the trial at first data cutoff, median imaging-based progression-free survival (ibPFS) was significantly longer in the abiraterone and olaparib arm than in the abiraterone and placebo arm (24.8 vs 16.6 months) and gave a 34% reduction in the risk of progression or death (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.54 to 0.81; p<0.001).²

Tom Keith-Roach, President, AstraZeneca UK, said: “Today’s decision by the SMC is hugely welcome. Extending access for olaparib, a product of British science already available to patients in England and Wales, to eligible patients in Scotland adds a much-needed new treatment option in an area with continued high unmet clinical need."

David Long, Head of Oncology at MSD UK, said: “Prostate cancer remains the most common cancer in men in Scotland and unfortunately patients with advanced disease can face an uncertain future. We are delighted that patients with advanced prostate cancer can now access olaparib without the need for a biomarker test, and we look forward to working with Scottish clinicians to offer this medicine to every eligible patient as fast as possible."

The safety and tolerability of Lynparza plus abiraterone and prednisone or prednisolone was in line with that observed in prior clinical trials and the known profiles of the individual medicines. At the time of this updated analysis, there were no new long-term safety issues identified.²

The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥ 10%) were nausea, fatigue/asthenia, anaemia, vomiting, diarrhoea, decreased appetite, headache, neutropenia, dysgeusia, cough, leukopenia, dizziness, dyspnoea, and dyspepsia.⁸ The Grade ≥3 adverse reactions occurring in > 2% of patients were anaemia (14%), neutropenia (5%), fatigue/asthenia (4%), leukopenia (2%) and thrombocytopenia (2%).⁸

[1] Scottish Medicine Consortium. Olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. Detailed advice document SMC2617 – published 11 March 2024

[2] Clarke NW, et al. Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer. NEJM Evidence 2022;1(9).

[3] Prostate Cancer. Prostate Scotland. Available at: https://www.prostatescotland.org.uk/disease-tests-and-treatments/prostate-cancer. Last accessed: March 2024.

[4] Kirby M, et al. Characterising the castration-resistant prostate cancer population: a systematic review. International Journal of Clinical Practice. 2021;65(11):1180-1192.

[5] Advanced Prostate Cancer. Urology Care Foundation. Available at: https://www.urologyhealth.org/urology-a-z/a_/advanced-prostate-cancer. Last accessed: March 2024

[6] Posdzich P, et al. Metastatic Prostate Cancer—A Review of Current Treatment Options and Promising New Approaches. 2023 Jan;15(2):461.

[7] George D, et al. Treatment Patterns and Outcomes in Patients With Metastatic Castration-resistant Prostate Cancer in a Real-world Clinical Practice Setting in the United States. 2020 Jan;18(4):284-294.

[8] Electronic Medicines Compendium (EMC). Lynparza 100 mg film-coated tablets – Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/9204/smpc#gref. Last accessed: March 2024.