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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

About LYNPARZA (olaparib) in Ovarian Cancer

Updated on 09/08/2019

ONCOLOGY

CHOOSE LYNPARZA (TABLETS) AS STANDARD OF CARE AT HER EARLIEST OPPORTUNITY FOR MAINTENANCE TREATMENT2,4

Choose LYNPARZA tablets as standard of care at her earliest opportunity for maintenance treatment banner Click here for more information on the SOLO-1 trial data

Who is LYNPARZA for?

LYNPARZA (tablets) is indicated as a 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.2

LYNPARZA (tablets) is indicated as monotherapy for 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 response or partial response) to platinum-based chemotherapy.2

Tablet, 150 mg image

Tablet, 150 mg*

Please note, a 100 mg tablet is also available

* images are not to scale

LYNPARZA (tablets) is recommended by NICE for use within the Cancer Drugs Fund as an option for the maintenance treatment of BRCAm, advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults.1 Find out full details of the NICE guidance.

LYNPARZA (capsules)

Watch Dr Banerjee discuss SOLO-1, the landmark phase 3 trial evaluating first-line LYNPARZA as maintenance therapy in newly diagnosed advanced ovarian cancer.4

Prescribing Information

First-line maintenance treatment with LYNPARZA (tablets) is supported by data from the SOLO-1 study4

Study design for the placebo controlled, double blinded SOLO-1 study4

Phase III trial image

Unprecedented efficacy vs. placebo

SOLO-1: Unprecedented efficacy with 60% of patients progression-free at 3 years (vs. 27% of placebo) (HR=0.30; 95% CI: 0.23–0.41; p<0.0001)

SOLO-1: Improved progression free survival in women with BRCAm advanced ovarian cancer4

Event-free graph

Adapted from Moore K, et al. 2018.

  • At a median follow-up of 41 months, median PFS was not reached in the LYNPARZA treatment group vs. 13.8 months for placebo (HR=0.30; 95% CI: 0.23–0.41; p<0.0001)4
  • A sensitivity analysis of PFS using Blinded Independent Central Review (BICR) was consistent with the primary endpoint, with median PFS not reached with LYNPARZA treatment vs. 14.1 months for placebo (HR=0.28 95% CI: 0.20, 0.39; p<0.001)4

SOLO-1: The benefit of LYNPARZA treatment in newly diagnosed patients is carried beyond the first progression

The benefit of LYNPARZA treatment in newly diagnosed patients graph

Adapted from Moore K, et al. 2018.

CI = Confidence Interval; HR = Hazard Ratio; PFS = Progression-free Survival; PFS2 = Time to Second Progression or Death; TFST = Time from Randomisation to First Subsequent Therapy or Death; TSST = Time from Randomisation to Second Subsequent Therapy or Death.

  • An interim analysis for overall survival demonstrated that this is not yet sufficiently mature to provide meaningful statistical analysis (maturity 21%)4

Do you BRCA test your ovarian cancer patients?9–18

Do you BRCA test your ovarian cancer patients? image

Tumour BRCA test all your newly diagnosed advanced ovarian cancer patients to identify those who may benefit from LYNPARZA 1L.19

  • Unlike germline testing, tumour testing can identify both germline and somatic BRCAm5
  • Subsequent germline testing can determine whether there are any familial implications for the patient's family19
22% of epithelial ovarian cancer patients carry a BRCAm
LYNPARZA efficacy in platinum-sensitive relapsed patients is supported by data collected in two randomised, placebo-controlled, double blinded studies: Study 19 and SOLO-211,23,24

Choose a maintenance treatment with…

  • Unprecedented efficacy:
    • 60% of newly diagnosed patients who received LYNPARZA maintenance treatment first-line in SOLO-1 remain progression-free at 3 years (vs 27% of placebo)4
    • In women with PSR advanced ovarian cancer, LYNPARZA maintenance treatment significantly reduced the risk of disease progression or death by 65%, regardless of BRCAm status (HR=0.35; 95% CI (0.25–0.49); P <0.0001)11
  • Unrivalled long-term follow-up efficacy data:
    • 11% of PSR patients in Study 19 who received LYNPARZA (capsules) have remained on treatment for 6 years27
  • A generally well-tolerated safety profile:
    • The safety profile is based on pooled data from 1,826 patients with solid tumours treated with LYNPARZA monotherapy in clinical trials at the recommended dose.2,6
    • LYNPARZA monotherapy has been associated with adverse reactions generally of mild or moderate severity and generally not requiring treatment discontinuation2,6
There are two formulations of LYNPARZA for you to choose from, depending on your patient’s needs and reimbursement opportunities2,6

References

  1. NICE guidance on olaparib for maintenance treatment of ovarian, fallopian tube or peritoneal cancer that has a BRCA germline mutation after response to first-line platinum-based chemotherapy. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10257.
  2. LYNPARZA 100mg and 150mg film-coated tablets Summary of Product Characteristics.
  3. Karakasis, K., Burnier, J. V., Bowering, V., Oza, A. M. & Lheureux, S. Ovarian Cancer and BRCA1/2 Testing: Opportunities to Improve Clinical Care and Disease Prevention. Frontiers in Oncology 6, (2016).
  4. Moore, K. et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N. Engl. J. Med. (2018). doi:10.1056/NEJMoa1810858.
  5. Capoluongo, E. et al. Guidance Statement On BRCA1/2 Tumor Testing in Ovarian Cancer Patients. Seminars in Oncology 44, 187–197 (2017).
  6. LYNPARZA 50 mg hard capsules Summary of Product Characteristics.
  7. NICE guidance on olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum-based chemotherapy. Available from: https://www.nice.org.uk/guidance/ta381
  8. Moore, K. et al. 2018. Oral presentation LBA7_PR, ESMO.
  9. Alsop, K. et al. BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group. J. Clin. Oncol. 30, 2654–2663 (2012).
  10. Swisher, E. M. et al. Secondary BRCA1 mutations in BRCA1-mutated ovarian carcinomas with platinum resistance. Cancer Res. 68, 2581–2586 (2008).
  11. Ledermann, J. et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. The Lancet Oncology 15, 852–861 (2014).
  12. Gourley, C. et al. Increased incidence of visceral metastases in scottish patients with BRCA1/2-defective ovarian cancer: an extension of the ovarian BRCAness phenotype. J. Clin. Oncol. 28, 2505–2511 (2010).
  13. Tan, D. S. P. & Kaye, S. B. Chemotherapy for Patients with BRCA1 and BRCA2-Mutated Ovarian Cancer: Same or Different? Am Soc Clin Oncol Educ Book 114–121 (2015). doi:10.14694/EdBook_AM.2015.35.114
  14. Bolton, K. L. et al. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA 307, 382–390 (2012).
  15. Petrucelli, N., Daly, M. B. & Feldman, G. L. Hereditary breast and ovarian cancer due to mutations in BRCA1 and BRCA2. Genet. Med. 12, 245–259 (2010).
  16. Surbone, A. Social and ethical implications of BRCA testing. Ann. Oncol. 22 Suppl 1, i60-66 (2011).
  17. Finch, A. et al. Salpingo-oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 Mutation. JAMA 296, 185–192 (2006).
  18. Domchek, S. M. et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA 304, 967–975 (2010).
  19. Vergote, I. et al. Current perspectives on recommendations for BRCA genetic testing in ovarian cancer patients. Eur. J. Cancer 69, 127–134 (2016).
  20. Pal, T. et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer 104, 2807–2816 (2005).
  21. Pennington, K. P. et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin. Cancer Res. 20, 764–775 (2014).
  22. Moschetta, M., George, A., Kaye, S. B. & Banerjee, S. BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer. Ann. Oncol. 27, 1449–1455 (2016).
  23. Pujade-Lauraine, E. et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. The Lancet Oncology 18, 1274–1284 (2017).
  24. Ledermann, J. et al. Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian Cancer. New England Journal of Medicine 366, 1382–1392 (2012).
  25. Friedlander, M. et al. Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy. British Journal of Cancer 119, 1075–1085 (2018).
  26. Ledermann, J. A. et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. The Lancet Oncology 17, 1579–1589 (2016).
  27. Gourley, C. et al. Clinically significant long-term maintenance treatment with olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol 35 (poster related to suppl; abstr 5533) (2017).
  28. Weil, M. K. & Chen, A. PARP Inhibitor Treatment in Ovarian and Breast Cancer. Curr Probl Cancer 35, 7–50 (2011).
  29. Aly, A. & Ganesan, S. BRCA1, PARP, and 53BP1: conditional synthetic lethality and synthetic viability. J Mol Cell Biol 3, 66–74 (2011).

Supporting documentation

100 mg and 150 mg film coated tablets
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

50 mg hard capsules
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-17803 | Date of Preparation: August 2019