For BRCAm* aOC, 1L maintenance LYNPARZA following response to 1L platinum-based chemotherapy1

Statistically significant PFS results and the longest follow-up assessment of OS to date in 1L maintenance aOC1-4

Illustrative Women With Ovarian Cancer

Not an actual patient.

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SOLO-1 in sBRCAm or gBRCAmSOLO-1 in sBRCAm or gBRCAm

In women with sBRCAm* or gBRCAm* advanced ovarian cancer following response to first-line platinum-based chemotherapy1,5

*Select patients for this indication based on an FDA-approved companion diagnostic for LYNPARZA.1

See the study design

Primary analysis

Unprecedented efficacy: Median PFS was not reached with LYNPARZA vs ~1.2 years (13.8 months) with placebo1,5

Estimated 60% progression-free survival at 3 years

Analysis based on Kaplan–Meier estimates. Study was not designed to detect a difference at the 3-year mark.

Median PFS1

LYNPARZA
not reached (NR)
Placebo
13.8 months

HR=0.30 (95% CI: 0.23–0.41); P<0.0001

Median duration of follow-up (primary analysis): 41 months for both LYNPARZA and placebo; DCO: May 17, 2018.5

Events, n (%): 102/260 (39) with LYNPARZA and 96/131 (73) with placebo.1

Blinded independent central review (BICR)1,5

Sensitivity analysis of PFS by BICR was consistent with the investigator-assessed PFS and confirmed the robustness of the data (HR=0.28 [95% CI: 0.20–0.39]).

BICR does not form part of the multiplicity strategy in SOLO-1.

LONG-TERM PFS DATA

PFS at the post hoc 5-year follow-up analysis

~4.7 years mPFS with LYNPARZA vs ~1.2 years with placebo6

The analyses at 1, 3, and 5 years are descriptive only; the SOLO-1 trial was not designed to assess a statistical difference between treatment groups at these time points.

  LYNPARZA Placebo
Median PFS (mo) 56 13.8
HR=0.33 (95% CI: 0.25–0.43)
Median PFS follow-up time (post hoc analysis not controlled for Type 1 error): 4.8 years for LYNPARZA and 5 years for placebo; DCO: March 5, 2020.6,7
SOLO-1 PFS Graph With LYNPARZASOLO-1 PFS Graph With LYNPARZA

Events, n (%): 118/260 (45) with LYNPARZA and 100/131 (76) with placebo.5,6

†In SOLO-1, treatment with LYNPARZA was continued for up to 2 years or until disease progression or unacceptable toxicity. Patients who remained in CR received a maximum treatment duration of 2 years; patients with evidence of disease could continue to receive LYNPARZA beyond 2 years. 26 (10%) patients on LYNPARZA continued beyond 2 years. At the time of DCO May 17, 2018, 13 patients were still receiving LYNPARZA.1,5

OVERALL SURVIVAL DATA

Descriptive interim 7-year follow-up OS analysis 

Median OS was not reached with LYNPARZA vs 75.2 months (~6.3 years) with placebo2

SOLO-1 Survival Graph With LYNPARZASOLO-1 Survival Graph With LYNPARZA

45%

reduction in risk of death

HR=0.55 (95% CI: 0.40–0.76)

Events, n (%): 84/260 (32.3) with LYNPARZA and 65/131 (49.6) with placebo.2

Interim median OS follow-up time: ~7.3 years (median duration of follow-up was 88.9 months for the olaparib arm and 87.4 months for placebo); DCO: March 7, 2022.2

This analysis is based on Kaplan–Meier estimates and is descriptive only.

†In SOLO-1, treatment with LYNPARZA was continued for up to 2 years or until disease progression or unacceptable toxicity. Patients who remained in CR received a maximum treatment duration of 2 years; patients with evidence of disease could continue to receive LYNPARZA beyond 2 years. 26 (10%) patients on LYNPARZA continued beyond 2 years. At the time of DCO May 17, 2018, 13 patients were still receiving LYNPARZA.1,5

SOLO-1 TRIAL DESIGN

SOLO-1: A phase 3 trial evaluating PFS as a primary endpoint and OS as a key secondary endpoint in BRCAm advanced ovarian cancer1,5

LYNPARZA SOLO-1 Trial Design ChartLYNPARZA SOLO-1 Trial Design Chart

‡Investigator-assessed PFS evaluated according to RECIST version 1.1.1

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at diagnosis is critical

ORR data

SOLO-1: BRCAm patients with residual disease after platinum-based therapy

Objective response rates for LYNPARZA and placebo8,9

LYNPARZA SOLO-1 BRCAm

LYNPARZA (n=54) | Placebo (n=26)

LYNPARZA ORR Data
LYNPARZA ORR Data

Over 1 in 4 patients

with residual disease experienced a conversion to a complete response with LYNPARZA

~1 in 7 patients

with residual disease experienced a conversion to a partial response with LYNPARZA

with residual disease experienced a conversion to a partial response with LYNPARZA

Placebo ORR Data
Placebo ORR Data

These post hoc analyses should be interpreted with caution because of the modest patient numbers and baseline imbalances. Patients were prospectively classified as responders if the RECIST criteria for a CR or PR were satisfied at any time, up to and including the defined analysis cutoff point. For each treatment group, the ORR was the number of CRs and PRs divided by the number of patients in the group in the full analysis set with measurable disease at baseline. Only patients with PR and measurable disease at enrollment could achieve an objective response of CR or PR. Although this analysis is defined as post hoc in the poster, the descriptive presentation of this data is described in version 1 of the protocol.8,9 Trial was not designed to assess statistical difference between treatment groups.5,8,9

See the SOLO-1 Safety