SOLO-2 Trial: LYNPARZA demonstrated PFS benefit in women with gBRCAm* recurrent ovarian cancer^1,2

In second-line maintenance treatment after response to platinum-based chemotherapy

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

SOLO-2 Study Design

SOLO-2 was a randomized, phase 3 study of 295 patients with a gBRCA1 and/or gBRCA2 mutation with platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer who received ≥2 prior lines of platinum-containing regimens.

Patients were randomized 2:1 (N=295):

• LYNPARZA tablets 300 mg BID (n=196)
• Placebo BID (n=99)

• *All patients had a deleterious or suspected deleterious gBRCAm as detected either by a local test (n=236) or by a central Myriad Clinical Laboratory Improvement Amendments (CLIA) test (n=59), subsequently confirmed by BRACAnalysis CDx^® (n=286).¹
• ^†The immature overall survival data showed no difference between the groups.²

Once the treating HCP determines that the patient has progressed clinically, no further scans are sent for. As a result, the BICR patient is “informatively censored.” Informative censoring may bias the estimate of treatment effect based on BICR.

HR=0.25 (95% CI: 0.18–0.35)

In women with platinum-sensitive recurrent ovarian cancer with a gBRCAm

• 5-year OS for LYNPARZA was 42% vs 33% with placebo³
• 5-year OS data were derived from Kaplan–Meier estimates. These analyses are descriptive only. The SOLO-2 trial was not powered to assess a statistical difference in OS between treatment groups at 5 years^2,3

Although OS was a prespecified secondary endpoint, the criterion for statistical significance (P<0.05) was not met. HR is unadjusted for crossover.³

*The P-value is derived from a stratified log-rank test.¹