Welcome to this UK AstraZeneca produced and funded website
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
This website is intended for UK Healthcare Professionals only. Other UK residents please visit astrazeneca.co.uk
Welcome to this UK AstraZeneca produced and funded website
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
Adapted from Clarke NW et al. 2022.5
*Except abiraterone; †Both therapies were used at full dose, equivalent to monotherapy regimens. Patients in both treatment arms also received prednisone/prednisolone 5 mg BID; ‡rPFS assessed by investigator per RECIST 1.1 (soft tissue) and PCWG-3 (bone) criteria.
Key secondary endpoint:
Additional endpoints:
Adapted from Clarke NW et al. 2022.3
*Baseline pain score is based on a patient completing the BPI-SF questionnaire item 3 (worst pain) at least once during the 7-day baseline period and is presented as an average.
†Investigators could select more than one site of disease. Entries for ‘Other locally advanced sites’, ‘Other distant sites’ and ‘Other’ have been excluded.
‡Prior to mCRPC, treatment with next-generation hormonal agents (except abiraterone) was allowed, provided patients had not had PSA, clinical or imaging-based progression during the treatment and the treatment was stopped at least 12 months before randomisation.
§HRRm: Any deleterious or suspected deleterious HRR gene mutation detected; non-HRRm: no deleterious or suspected deleterious HRR gene mutation detected; HRRm unknown: patients for whom mutation testing was not performed or where mutation testing failed due to insufficient quantity or quality of the sample, or technical failure at sequencing or post-sequencing steps on analysis. Use of aggregate test data was considered the favoured method for assignment of PROpel patients to HRRm subgroups to maximise the proportion of patients with assigned HRRm status and minimise potential false-negative results.
Adapted from Clarke NW et al. 20225 and Saad F et al. 2022.7
DCO1: 30 July 2021. Events: 394; 49.5% maturity.
*Patients in both treatment arms also received prednisone/prednisolone 5 mg BID
Adapted from Saad F et al. 2022.7
DCO1: 30 July 2021.
Patients in both treatment arms also received prednisone/prednisolone 5 mg BID.
*The HRRm status of patients in PROpel was determined retrospectively using results from tumour tissue and plasma ctDNA HRRm tests. Patients were classified as HRRm if (one or more) HRR gene mutation was detected by either test; patients were classified as non-HRRm patients if no HRR gene mutation was detected by either test; patients were classified as unknown HRRm if no valid HRR test result from either test was achieved. 18 patients did not have a valid HRR testing result from either a tumour tissue or ctDNA test and were excluded from the subgroup analysis.
†Global interaction test not significant at 10% level.
Adapted from Clarke NW et al. 2023.9
DCO3: 12 October 2022.
*Patients in both treatment arms also received prednisone/prednisolone 5 mg BID.
†Median duration of follow-up for censored patients at DCO3 was 36.6 months (range 8.3–47.0) in the LYNPARZA arm and 36.5 months (range 2.9–45.3) in the placebo + abiraterone arm.
The secondary endpoint of HRQoL was similar between treatment arms, with no clinically meaningful detriment to HRQoL5,10
Adapted from Armstrong AJ et al. 2023.10
DCO3: 12 October 2022.
*Plot includes 95% confidence limits. FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A clinically meaningful change in FACT-P total score is 10.
†Patients in both treatment arms also received prednisone/prednisolone 5mg BID
Data cut-off 3: 12 October 2022.
Data cut-off 3: 12 October 2022.
4 out of 5 patients remain on LYNPARZA combination therapy without discontinuation due to AEs, however 49% of patients did require a dose interruption.9
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.3,9
Adapted from Clarke NW et al. 2023.9
DCO3: 12 October 2022.
Safety was assessed through the reporting of AEs according to the NCI CTCAE v4.03 and laboratory assessments. Patients in both treatment arms also received prednisone/prednisolone 5 mg BID.
*Anaemia category includes anaemia, decreased haemoglobin level, decreased red cell count, decreased haematocrit level, erythropenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia, and normocytic anaemia.
MDS/AML
Two cases of MDS/AML were observed with LYNPARZA combination therapy vs the placebo and abiraterone arm in PROpel9
VTEs
In PROpel, VTE events occurred in 8.5% vs 4% (at DCO3) in the LYNPARZA combination therapy and placebo and abraterone arm, respectively.9 This is consistent with other observations in other PARPi studies in mCRPC.3,9,11 The majority of PE events were asymptomatic and incidental on imaging3,9
Pneumonitis
Incidence of pneumonitis was balanced between the LYNPARZA combination therapy and placebo and abiraterone arm (5 vs 3 cases, respectively)9
Please refer to the SmPC for a full list of adverse events and special warnings.
Please refer to the SmPC for further information to minimise the risks associated with the use of the medicine before making any prescribing decisions.
1L=first-line; abi=abiraterone; AE=adverse event; AML=acute myeloid leukaemia; BICR=blinded independent central review; BID=twice a day; BPI-SF=Brief Pain Inventory - Short Form; BRCAm=breast cancer gene mutation; CBC=complete blood count; CI=confidence interval; CTC=circulating tumour cell; CTCAE=Common Terminology Criteria for Adverse Events; ctDNA=circulating tumour DNA; DCO=data cut-off; ECOG=Eastern Cooperative Oncology Group; FACT-P=Functional Assessment of Cancer Therapy-Prostate; HR=hazard ratio; HRQoL=health-related quality of life; HRR=homologous recombination repair; HRRm=homologous recombination repair mutation; IQR=interquartile range; ITT=intention-to-treat; LFT=liver function test; LS=least squares; mCRPC=metastatic castration-resistant prostate cancer; MDS=myelodysplastic syndrome; mHSPC=metastatic hormone-sensitive prostate cancer; NICE=National Institute for Health and Care Excellence; NHA=novel hormonal agent; NS=not significant; ORR=objective response rate; OS=overall survival; PARPi=poly (ADP-ribose) polymerase inhibitor; PFS=progression-free survival; PFS2=time to second objective disease progression; pre=prednisone/prednisolone; PSA=prostate-specific antigen; rPFS=radiographic PFS; SE=standard error; SMC=Scottish Medicines Consortium; SSRE=symptomatic skeletal-related event; TFST=time to first subsequent therapy; VTE=venous thromboembolism.
GB-73794 | DOP: February 2026
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
Welcome to this UK AstraZeneca produced and funded website
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
GB-74216| DOP : February 2026
