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SOLO3

Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial

Phase 3N = 266NCT02282020

Population
Germline BRCA-mutated platinum-sensitive relapsed ovarian cancer after at least two prior lines of platinum-based chemotherapy
Design
Randomised, open-label phase 3 trial. Patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least two prior lines of platinum-based chemotherapy were randomised 2:1 to olaparib 300 mg twice daily (tablets) or physician's-choice single-agent non-platinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine or topotecan). Primary end point ORR by blinded independent central review in the measurable-disease analysis set; key secondary end point BICR-assessed PFS in the ITT population.
Primary endpoint
ORR
Arms
  • Olaparib (experimental, n = 178): Olaparib tablets 300 mg twice daily
  • Non-platinum chemotherapy (control, n = 88): Physician's-choice single-agent pegylated liposomal doxorubicin, paclitaxel, gemcitabine or topotecan
People
Penson RT
Δ ORR+20.8 pointsPFSHR 0.62 (95% CI 0.43–0.91)Δ median PFS+4.2 months
Show the numbers
Results reported for SOLO3
EndpointAnalysisOlaparibNon-platinum chemotherapyEffect
ORRMeasurable disease (olaparib n=151, chemotherapy n=72)primaryPenson 202072.2%51.4%P=0.002Assessed by blinded independent central review. Odds ratio 2.53 (95% CI 1.40-4.58).
PFSprimaryPenson 2020median 13.4 monthsmedian 9.2 monthsHR 0.62 (95% CI 0.43–0.91)P=0.013Key secondary end point, assessed by blinded independent central review.
Results reported for SOLO3
EndpointAnalysisOlaparibNon-platinum chemotherapyEffect
ORRMeasurable disease (olaparib n=151, chemotherapy n=72)primaryPenson 202072.2%51.4%P=0.002Assessed by blinded independent central review. Odds ratio 2.53 (95% CI 1.40-4.58).
PFSprimaryPenson 2020median 13.4 monthsmedian 9.2 monthsHR 0.62 (95% CI 0.43–0.91)P=0.013Key secondary end point, assessed by blinded independent central review.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.620.43–0.91
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Olaparib (experimental)
  • Non-platinum chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsOlaparibNon-platinum chemotherapy
0100.0%100.0%
866.1%54.7%
1741.5%27.8%
2527.4%15.2%
3417.2%7.7%
Primary publication: Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidziński M, et al. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020;38(11):1164-1174. PubMedDOI

Appears in

Sources

  1. Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidziński M, et al. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020;38(11):1164-1174.

    PubMedDOI