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