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

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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