Lynparza (olaparib)

SOLO-1

SOLO-1 study design:5

SOLO-1 was a randomised, double-blind, international Phase III trial5

BD=twice daily; BRCA1=breast cancer gene 1; BRCA2=breast cancer gene 2; PFS=progression-free survival; RECIST=response evaluation criteria in solid tumours

SOLO-1 baseline characteristics:5

Baseline characteristics were well balanced across treatment groups in SOLO-15

BRCA1=breast cancer gene 1; BRCA2=breast cancer gene 2; ECOG=Eastern Cooperative Oncology Group; FIGO=Federation Internationale de Gynecologie et d’Obstetrique

SOLO-1: A landmark study in newly diagnosed BRCAm ovarian cancer

SOLO-1 primary endpoint: after a median follow-up of 41 months, the median PFS had not been reached in the Lynparza arm (vs. 13.8 months for placebo)5

In a post-hoc analysis, SOLO-1 demonstrated substantial efficacy in the newly diagnosed BRCAm ovarian cancer setting; with 48% of women who received Lynparza exhibiting progression-free survival at 5 years vs 21% of placebo treated patients.9

Adapted from: Banerjee S, et al. 2020
DCO: March 2020; Median follow-up: olaparib, 4.8 years, placebo, 5.0 years
DCO = data cut-off; CI = confidence interval; HR = hazard ratio; PFS = progression-free survival
 
  • After a median follow-up of ∼5 years, median PFS was 4.7 years (56.0 months) in the Lynparza treatment group (vs. 13.8 months for placebo) (HR=0.33; 95% CI: 0.25-0.43)9
  • SOLO-1 is the only trial to report long-term follow-up of first-line PARP inhibitor maintenance treatment in the advanced ovarian cancer setting, demonstrating a substantial PFS benefit of >3.5 years for Lynparza vs. placebo9

Adapted from: Banerjee S, et al. 2020

 

After a 5-year follow up; overall survival data remains immature.

*Measured from randomisation. Primary DCO: May 2018 (Median follow-up: Lynparza 40.7 months, placebo 41.2 months). 5-year DCO: March 2020 (Median follow-up: Lynparza, 4.8 years, placebo, 5.0 years).
DCO=data cut-off; HR=hazard ratio; NR=not reached; PFS=progression-free survival; PFS2=time to progression on subsequent therapy; TFST=time to first subsequent therapy, TSST=time to second subsequent therapy.

 

 

SOLO-1: At the time of the primary analysis, after a median follow-up of ∼3 years:5

Please use the toolbar on the left-hand side to access the relevant safety section for further information.

Lynparza licence and reimbursement summary

Lynparza maintenance therapy (monotherapy and in combination with bevacizumab) is available for reimbursement subject to the following criteria:

In England

  • Lynparza (tablets) is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of BRCA mutation‑positive, 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. It is recommended only if the conditions in the managed access agreement for Lynparza are followed10
  • Lynparza (tablets) is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if they have a BRCA1 or BRCA2 mutation, have had 2 courses of platinum-based chemotherapy and the conditions in the managed access agreement for Lynparza are followed.11 
  • Lynparza (tablets) in combination with bevacizumab are intended for use as maintenance treatment of adult patients with advanced (FIGO stages 3 and 4) 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 instability3,12

In Scotland

  • Lynparza (tablets) is accepted for use within NHS Scotland for the maintenance treatment of adult patients with advanced (FIGO stages 3 and 4) 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 chemotherapy13
  • Lynparza (capsules) is accepted for use within NHS Scotland for the maintenance treatment of adult patients with advanced (FIGO stages 3 and 4) 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 chemotherapy14

Summary of Lynparza tablets licences, indications and reimbursement status in ovarian cancer1,3,9-14

1L=first-line; 2L=second-line; 3L+=third-line or greater; BRCAm=BRCA1/2-mutated; HRD=homologous recombination deficient.

Lynparza tablets (100 mg and 150 mg) should not be substituted for Lynparza capsules (50 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation; therefore, the specific dose recommendations for each formulation should be followed.1

Back to top