LYNPARZA® (olaparib) | SOLO-1 trial

Prescribing Information LYNPARZA (olaparib) United Kingdom

Adverse Event Reporting

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These Lynparza website pages were funded and produced by AstraZeneca UK and MSD UK

Make HER first-line count in the maintenance setting in newly diagnosed aOC

Lynparza is the first PARP inhibitor to report 7-year follow-up data in newly diagnosed aOC²

Study design
Efficacy
Safety profile
Indication

SOLO-1 demonstrated the efficacy of 1L Lynparza as maintenance therapy in newly diagnosed BRCAm aOC³

Graph showing key secondary endpoint: OS for Lynparza + bevacisumab vs bevacisumab + placebo in BRCAm population

Primary PFS data cut-off: 17 May 2018.
*Analysis was performed after 198 progression events had occurred (in 50.6% of patients).
†’Not reached’ reflects persistent PFS in this treatment arm.

Patients receiving Lynparza presented a 67% reduction in risk of disease progression compared with placebo⁴

'Graph showing key secondary endpoint: OS for Lynparza + bevacisumab vs bevacisumab + placebo

Follow-up PFS data cut-off: 5 March 2020. 5-year PFS follow-up data was a post hoc analysis and was not pre-specified and therefore not statistically significant.

*13 patients, all in the Lynparza arm, continued study treatment past 2 years.

More than 2/3 patients treated with Lynparza were alive at 7 years vs less than half of patients on placebo (significance not reached)²

Graph showing primary endpoint: PFS for Lynparza + bevacisumab vs bevacisumab + placebo in BRCAm population

7-year descriptive OS data cut-off: 7 March 2022. Median duration of follow-up approximately 88 months.

*Two-sided P value of <0.0001 required to declare statistical significance.

† ‘Not reached’ reflects persistent OS in this treatment arm.

Learn more about this trial from UK experts,
and patient case studies

Lynparza tablets were generally manageable, and the safety profile at 7 years remained consistent with the primary analysis^1,2

Tornado plot showing AEs for Lynparza + bevacisumab vs bevacisumab + placebo

7-year descriptive OS data cut-off: 7 March 2022. Median duration of follow-up approximately 88 months.
*Data are shown for treatment-emergent AEs that occurred in at least 10.0% of patients in either treatment group during study treatment or up to 30 days after discontinuation of study treatment.
†Includes patients with anaemia or decreased haemoglobin.
‡Includes patients with neutropenia, febrile neutropenia or decreased neutrophil count.
§Includes patients with thrombocytopenia or decreased platelet count.

Image showong proportion of patients requiring dose reductions, interuptions or discontinations due to AEs with Lynparza

Visit our dosing page to learn more about flexible
dosing with Lynparza to help manage AEs

Lynparza tablets therapeutic indications¹

Lynparza tablets are indicated as
monotherapy for:

The maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
The maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Lynparza in combination with bevacizumab
is indicated for:

The maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

Please consult the SmPC for further information before making any prescribing decisions.

1L, first-line; AE, adverse event; aOC, advanced Ovarian Cancer; BD, twice daily; BRCAm, BRCA1 or BRCA2 mutation; CI, confidence interval; FACT-O TOI, Functional Assessment of Cancer Therapy–Ovarian Trial Outcome Index; FIGO, Fédération Internationale de Gynécologie et d’Obstétrique; HR, hazard ratio; HRD, homologous recombination deficiency; HRQoL, health-related quality of life; ITT, intention to treat; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; TFST, time from randomisation to first subsequent anti-cancer therapy/death; TSST, time to second subsequent therapy or death.

Lynparza (olaparib) Summary of Product Characteristics.
DiSIlvestro P, et al. J Clin Oncol. 2023;41:609–617.
Moore K, et al. N Engl J Med. 2018;379:2495–2505.
Banerjee S, et al. Lancet Oncol. 2021;22:1721–1731.

GB-73641 | 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.

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.

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Lynparza is the first PARP inhibitor to report 7-year follow-up data in newly diagnosed aOC2

SOLO-1 demonstrated the efficacy of 1L Lynparza as maintenance therapy in newly diagnosed BRCAm aOC3

Patients receiving Lynparza presented a 67% reduction in risk of disease progression compared with placebo4

More than 2/3 patients treated with Lynparza were alive at 7 years vs less than half of patients on placebo (significance not reached)2

Lynparza tablets were generally manageable, and the safety profile at 7 years remained consistent with the primary analysis1,2

Lynparza tablets therapeutic indications1

Lynparza tablets are indicated asmonotherapy for:

Lynparza in combination with bevacizumabis indicated for:

Abbreviations and References