Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL)

Objective. The randomized phase 3 CORAIL trial evaluated whether lurbinectedin improved progression-free survival (PFS) compared to pegylated liposomal doxorubirin (PLD) or topotecan in patients with platinumresistant ovarian cancer. Methods. Patients were randomly assigned (1:1) to lurbinectedin 32 mg/m(2) 1-h i.v. infusion q3wk (experimental arm), versus PLD 50 mg/m(2) 1-h i.v. infusion q4wk or topotecan 1.50 mg/m(2) 30-min i.v. infusion Days 1-5 q3wk (control arm). Stratification factors were PS (0 vs. >= 1), prior PR (1-3 months vs. >3 months), and prior chemotherapy lines (1-2 vs. 3). The primary endpoint was PFS by Independent Review Committee in all randomized patients. This study was registered with ClinicalTrials.gov , NCT02421588. Results. 442 patients were randomized: 221 in lurbinectedin arm and 221 in control arm (127 PLD and 94 topotecan). With a median follow-up of 25.6 months, median PFS was 3.5 months (95% CI, 2.1-3.7) in the lurbinectedin arm and 3.6 months (95% CI, 2.7-3.8) in the control arm (stratified log-rank p = 0.6294; HR = 1.057). Grade >= 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (p = 0.0005), mainly due to hematological toxirities. The most common grade >= 3 AEs were: fatigue (7.3% of patients) and nausea (5.9%) with lurbinectedin; mucosal inflammation (8.5%) and fatigue (8.0%) in the control arm. Conclusions. The primary endpoint of improvement in PFS was not met. Lurbinectedin showed similar antitumor efficacy and was better tolerated than current standard of care in patients with platinum-resistant ovarian cancer. (C) 2021 Elsevier Inc. All rights reserved.

Automated summary

The CORAIL trial did not find an improvement in progression-free survival with lurbinectedin compared to standard treatments for platinum-resistant ovarian cancer. However, lurbinectedin showed similar antitumor efficacy and better tolerance compared to current standard of care in this patient population.