A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT03776812
Phase II
Drug Class Hormonal Therapy: GR
Drug Name Relacorilant
Alternate Drug Names RELA, CORT125134
Drugs in Trial nab-Paclitaxel, Relacorilant
Eligible Participant

Platinum resistant and refractory ovarian cancer

Patients Enrolled

178

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, DoR, PFS, OS, evaluated per RECIST

Efficacy

Intermittent Rel+Nab (n=60) vs Nab (n=60):

ORR: 35.7 vs 35.8%
PFS: 5.6 vs 3.8 months, HR: 0.66 (0.44-0.98, p=0.038)
DoR: 5.6 vs 3.7 months, HR: 0.36 (0.16-0.77, p=0.006)
OS: 13.9 vs 12.2 months, HR: 0.67 (0.43-1.03, p=0.066)

Exploratory analysis: no primary Pt-Rf; no primary Pt-Rf and 1-3 prior therapies (Phase III inclusion criteria); GR high:
Intermittent Rel+Nab vs Nab:

no primary Pt-Rf:
OS: 13.9 vs 12. 2 months, HR: 0.63 (0.39-0.99, p=0.045)

no primary Pt-Rf and 1-3 prior therapies:
ORR: 41.9 vs 38.6%
PFS: 5.6 vs 3.8 months, HR: 0.58 (0.37-0.91, p=0.016)
DoR: 5.6 vs 3.6 months, HR: 0.26 (0.11-0.52, p=0.001)
OS: 13.9 vs 12. 2 months, HR: 0.52 (0.31-0.86, p=0.010)

High tumor GR: GR IHC H-score ≥100 (65%, 82/129):
High GR is associated with non-response to Nab-only (SD or PD)
High GR is associated with good response (PR or CR) in patients receiving Rel + Nab
2 P= 0.037)

Clinically Significant Adverse Events

Intermittent Rel+Nab vs Nab:
Serious AE:
Grade 3-4 AE: neutropenia (6.7 vs 13.3%)

Conclusion

Intermittent relacorilant+nab-paclitaxel improves PFS and DoR and has a favorable safety profile in recurrent platinum resistant and/or platinum refractory ovarian cancer patients

Reference

Lorusso D et al. Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study. Annals Oncol (2021) 32 (suppl_5): abstract 721O
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/relacorilant-a-selective-glucocorticoid-receptor-modulator-in-combination-with-nab-paclitaxel-improves-progression-free-survival-in-patients-with

Colombo N et al. Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. J Clin Oncol 40, 2022 (suppl 17; abstr LBA5503)
https://ascopubs.org/doi/10.1200/JCO.2022.40.17_suppl.LBA5503

Colombo N et al. Slide from presentation
https://www.clearityfoundation.org/wp-content/uploads/2022/06/Relacorilant-OS-wo-Prim-Pt-Rf-ASCO-2022.jpeg

Lorusso D et al. Glucocorticoid receptor expression and activity in a phase II ovarian cancer trial of the glucocorticoid receptor modulator relacorilant in combination with nab-paclitaxel. ESMO (2022) Abstract 524MO
https://oncologypro.esmo.org/meeting-resources/esmo-congress/glucocorticoid-receptor-expression-and-activity-in-a-phase-ii-ovarian-cancer-trial-of-the-glucocorticoid-receptor-modulator-relacorilant-in-combina

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