Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer - Phase III SOLO3 Study Final Overall Survival Results

Sep 21, 2026

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Olaparib treatment significantly improved objective response rate and progression-free survival versus nonplatinum chemotherapy in BRCAmutated platinum-sensitive relapsed ovarian cancer in the open-label phase III SOLO3 trial. Final overall survival (OS) is reported as the prespecified secondary endpoint, including post hoc OS by number of prior chemotherapy lines and exploratory BRCA reversion mutation analysis. Among 266 randomized patients, OS was similar overall (HR 1.07), with favorable outcomes in those with two prior lines but possible harm in those with at least three lines; BRCA reversion mutations may have contributed.

LanguageEnglish

CategoryHealthcare

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Pages10

Reading Time25 min

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Abstract

Introduction

Methods

Trial design and eligibility

Data supplement and endpoints

Clinical Trial Updates Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results Giovanni Scambia, MD1 ; Ricardo Villalobos Valencia, MD2 ; Nicoletta Colombo, MD3,4 ; David Cibula, MD, PhD5 ; Charles A. Leath III, MD, MSPH6 ; Mariusz Bidziski, MD7; Jae-Weon Kim, MD, PhD8 ; Joo Hyun Nam, MD, PhD9; Radoslaw Madry, MD10 ; Carlos Hernndez, MD11; Paulo A.R. Mora, MD, MPH, PhD12 ; Sang Young Ryu, MD, PhD13; Mei-Lin Ah-See, MD, MRCP, FRCR14; Elizabeth S. Lowe, MD15; Natalia Lukashchuk, PhD16 ; Dave Carter, MSc17; and Richard T. Penson, MD, MRCP18 DOI [https://doi.org/10.1200/JCO.24.00933](https://doi.org/10.1200/JCO.24.00933) ABSTRACT Olaparib treatment signiﬁcantly improved objective response rate (primary end point) and progression-free survival versus nonplatinum chemotherapy in patients with BRCAmutated platinum-sensitive relapsed ovarian cancer in the open-label phase III SOLO3 trial ([ClinicalTrials.gov](ClinicalTrials.gov) identiﬁer: NCT02282020). We report ﬁnal overall survival (OS; prespeciﬁed secondary endpoint), post hoc OS analysis by number of previous chemotherapy lines, and exploratory BRCA reversion mutation analysis. Two hundred sixty-six patients were randomly assigned 2:1 to olaparib tablets (300 mg twice daily; n 5 178) or physician’s choice of single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan; n 5 88) . OS was similar with olaparib versus chemotherapy (hazard ratio [HR], 1.07 [95% CI, 0.76 to 1.49]; P 5 .71, median 34.9 and 32.9 months, respectively, full analysis set) . OS with olaparib was favorable in patients with two previous chemotherapy lines (HR, 0.83 [olaparib v chemotherapy][95% CI, 0.51 to 1.38]; median 37.9 v 28.8 months); however, a potential detrimental effect was seen in patients with at least three previous chemotherapy lines (HR, 1.33 [95% CI, 0.84 to 2.18]; median 29.9 v 39.4 months) . BRCA reversion mutations might have contributed to this ﬁnding. No patient randomly assigned to olaparib with a BRCA reversion mutation detected at baseline (6 of 170 [3.5%]) achieved an objective tumor response. ACCOMPANYING CONTENT Data Supplement Protocol Accepted October 8, 2024 Published December 12, 2024 J Clin Oncol 43:1408-1416 © 2024 by American Society of Clinical Oncology View Online Article Creative Commons Attribution Non-Commercial No Derivatives 4.0 License INTRODUCTION Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, received US Food and Drug Administration–accelerated approval as a treatment for advanced ovarian cancer (OC), germline (g) BRCA1 and/or BRCA2 mutation (BRCAm) and ≥3 prior chemotherapy lines based on Study 421-3; however, aconﬁrmatory trial was required. SOLO3 evaluated olaparibmonotherapy versus physician’s choice of single-agent nonplatinum chemotherapy in gBRCAm platinum-sensitive relapsed OC after ≥2 previous platinum-based chemotherapy (PBC) lines.4 SOLO3 met its primary end point: olaparib statistically signiﬁcantly improved objective response rate (ORR) versus chemotherapy(72.2% v51.4%, odds ratio,2.53[95%CI,1.40 to 4.58], P 5 .002).4 Progression-free survival (PFS) also favored olaparib versus chemotherapy (hazard ratio [HR], 0.62 [95% CI, 0.43 to 0.91]; P 5 . 01; median PFS 13.4 v 9.2 months).4 We report ﬁnal overall survival (OS); post hoc analysis of PFS, ORR (primary data cutoff [DCO]), and OS (ﬁnal DCO) by number of previous chemotherapy lines; and exploratory analyses of ORR by BRCAm status. METHODS SOLO3 ([ClinicalTrials.gov](ClinicalTrials.gov) identiﬁer: NCT02282020) was a randomized, controlled, open-label, phase III trial in 13 countries (trial design previously reported4) . Patients were randomly assigned 2:1 to olaparib or physician’s choice (before random assignment) of single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, pac

FAQs

What trial is reported and what is the main focus of the results?

The report summarizes final overall survival results from the phase III SOLO3 trial comparing olaparib with nonplatinum single-agent chemotherapy in platinum-sensitive relapsed, germline BRCA-mutated ovarian cancer.

How did overall survival compare between olaparib and chemotherapy?

Overall survival was similar between groups with a hazard ratio of 1.07 (95% CI, 0.76 to 1.49) and no statistically significant difference.

What role might BRCA reversion mutations play in the findings?

Exploratory analysis suggests BRCA reversion mutations might have contributed, as patients with detected reversion mutations at baseline did not achieve objective tumor response after randomization to olaparib.

Sep 21, 2026

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