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

Platinum resistant and refractory high grade serous or endometrioid ovarian cancer or ovarian carcinosarcoma

178, median 3 prior therapies (1-5)

Recurrence

Open-Label, Randomized

ORR, DoR, PFS, OS, evaluated per RECIST

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 and 1-3 prior therapies (Phase III inclusion criteria); GR high, prior Bev:
Intermittent Rel+Nab vs Nab:
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)

w/ prior Bev:
ORR: 40.7 vs 33.3%
PFS: 7.2 vs 3.7 months, HR: 0.44 (0.24-0.78, p=0.005)
DoR: 5.6 vs 3.4 months, HR: 0.25 (0.08-0.83, p=0.006)
OS: 17.9 vs 12. 6 months, HR: 0.47 (0.24-0.94, p=0.031)

w/o prior Bev:
ORR: 31.0 vs 39.1%
PFS: 5.4 vs 3.8 months, HR: 0.91 (0.48-1.72, p=0.767)
DoR: 3.8 vs 3.8 months, HR: 0.47 (0.13-1.68, p=0.234)
OS: 11.3 vs 12. 2 months, HR: 0.80 (0.42-1.52, p=0.501)

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 (χ2 P= 0.037)

Intermittent Rel+Nab vs Nab:
Serious AE: overall (5 vs 8.3%)
Grade 3-4 AE: neutropenia (6.7 vs 15%), fatigue or asthenia (11.7 vs 1.7%)

Intermittent relacorilant+nab-paclitaxel improves PFS, DoR and OS and has a favorable safety profile in recurrent platinum resistant ovarian cancer patients who have received prior bevacizumab

Colombo N et al. IGCS (2022) Poster
https://www.clearityfoundation.org/wp-content/uploads/2023/09/ROSELLA-Poster-IGCS-2022.pdf

Colombo N et al. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol (2023) 41(30):4779-4789
https://pubmed.ncbi.nlm.nih.gov/37364223/