ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): Relacorilant + Nab-Paclitaxel in the Subgroup of Patients With Platinum-Resistant Ovarian Cancer (PROC) Previously Exposed to a PARP Inhibitor

Summary

• ROSELLA met its primary endpoint of improving PFS:  Relacorilant, a first-in-class, oral, SGRA, in combination with nab-paclitaxel extended progression-free survival by BICR (HR 0.70, log-rank test P=0.0076) compared to nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer.
  • At the interim overall survival analysis, the addition of relacorilant to nab-paclitaxel showed a clinically meaningful 4.5-month median improvement in overall survival (median 16.0 vs 11.5 months, HR 0.69, nominal log-rank test P=0.0121).
• Consistent benefit in the PARP inhibitor-progressor subgroup: Relacorilant + nab-paclitaxel showed a PFS benefit in subgroups of patients with prior PARP inhibitor treatment (HR 0.60, nominal log-rank test P=0.0035) and progression while on a PARP inhibitor (HR 0.56, nominal log-rank test P=0.0046), with a median PFS of 7.36 months for both subgroups.
• Well-tolerated, favorable safety profile: The safety profile in the prior PARP inhibitor exposed subgroup was comparable to the overall safety population.

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