FOR THE FIRST TIME, UK PATIENTS WITH AN ADVANCED FORM OF PROSTATE CANCER CAN ACCESS LYNPARZA (OLAPARIB) PLUS ABIRATERONE AND PREDNISONE OR PREDNISOLONE COMBINATION THERAPY WITHOUT THE NEED FOR A BIOMARKER TEST

Olaparib is the first PARP inhibitor to demonstrate a clinically meaningful benefit when combined with abiraterone and prednisone or prednisolone to treat hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy, regardless of biomarker status.1

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Combination therapy showed a 34% reduction in the risk of disease progression or death in the PROpel Phase III trial.2 Safety and tolerability was in line with prior clinical trials and the known profiles of the individual medicines.2

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Approximately 140 men are diagnosed with prostate cancer each day in the UK, and around 10-20% of patients with advanced prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years.3,4 At least 84% of these patients will have metastases at the time of CRPC diagnosis.4

London, UK, Thursday 21 December 2023 – AstraZeneca and MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA [NYSE: MRK]) today announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, as an option within its marketing authorisation, for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy.1

In the UK, more than 52,000 men are diagnosed with prostate cancer every year.3 Approximately 10-20% of prostate cancers are 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) it is typically hard to treat and has a poor prognosis.5,6 With half of patients with mCRPC only ever receiving one line of therapy, there is an urgent unmet need for new treatments and to optimise outcomes in the first-line treatment of mCRPC.7

Professor Noel Clarke, Professor of Urological Oncology at The Christie, and Salford Royal Hospitals, said: “Data from the PROpel Phase III trial show that olaparib in combination with abiraterone and prednisone or prednisolone provides real benefit for men with metastatic castration-resistant prostate cancer. Typically, this type of prostate cancer is challenging to treat and often has a poor prognosis. Today’s recommendation by NICE, which enables this new combination therapy to be prescribed on the NHS, will provide a much needed effective therapy for men with this condition.”

This NICE recommendation 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: “We are truly delighted that olaparib, a treatment that represents the best of British science, is now available to even more UK patients. Critically, this is the first time that patients with this form of prostate cancer will be able to access a PARP inhibitor without the need for a specific biomarker test."

David Long, Head of Oncology at MSD UK, said: “We are delighted that NICE has recognised the clinical and economic benefits of olaparib in combination with abiraterone and prednisone or prednisolone as a first-line, targeted treatment for metastatic castration-resistant prostate cancer. This type of prostate cancer has unacceptable survival rates, and today’s NICE recommendation marks a vital step forward in changing the narrative for these patients.”

The safety and tolerability of Lynparza plus abiraterone 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 (15%), neutropenia (5%), fatigue/asthenia (4%), leukopenia (3%) and thrombocytopenia (2%).8