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, evaluated per RECIST

Efficacy

Continuous Rel+Nab (n=58) vs Intermittent Rel+Nab (n=60) vs Nab (n=60):

ORR: 35.2 vs 35.7 vs 35.8%
PFS: 5.29 vs 5.55 vs 3.76 months; HR: 0.66 (0.44-0.98, p=0.038) (int vs Nab)
DoR: 3.79 vs 5.55 vs 3.65 months; HR: 0.36 (0.16-0.77, p=0.006) (int vs Nab)

Clinically Significant Adverse Events

Continuous Rel+Nab vs Intermittent Rel+Nab vs Nab:
Serious AE:
Grade 3-4 AE: neutropenia (24.6 vs 6.7 13.3%), anemia (19.3 vs 13.3 vs 11.7%), neuropathy (15.8 vs 0 vs 5.0%)

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

Contact Us
Contact Us

We are here to help! Send us a message below or give us a call at (858) 657-0282.