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Proffered Paper session - Gynaecological cancers

721O - 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

Date

17 Sep 2021

Session

Proffered Paper session - Gynaecological cancers

Presenters

Domenica Lorusso

Citation

Annals of Oncology (2021) 32 (suppl_5): S725-S772. 10.1016/annonc/annonc703

Authors

N. Colombo1, D.D. Nguyen2, G.F. Fleming3, R.N. Grisham4, D. Lorusso5, T. Van Gorp6, A. Oaknin7, H.I. Pashova8, A. Grauer2

Author affiliations

  • 1 Department Of Gynecologic Oncology, University of Milan-Bicocca, European Institute of Oncology IRCCS, 20141 - Milano/IT
  • 2 Clinical Development, Corcept Therapeutics, 94025 - Menlo Park/US
  • 3 Hematology/oncology, University of Chicago Department of Medicine, 60637-1470 - Chicago/US
  • 4 Division Of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, 10065 - New York/US
  • 5 Gynaecology Oncology Unit, Fondazione Policlinico Universitario Gemelli, Rome/IT
  • 6 Department Of Gynaecology - Division Of Gynaecological Oncology, University Hospitals Leuven / Leuven Cancer Institute, 3000 - Leuven/BE
  • 7 Medical Oncology Dept., Vall d`Hebron University Hospital Institut d'Oncologia, 8035 - Barcelona/ES
  • 8 Biostatistics, Corcept Therapeutics, 94025 - Menlo Park/US
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Resources

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Abstract 721O

Background

Pre-clinical and clinical data indicate that glucocorticoid receptor (GR) antagonism may enhance/restore chemotherapy sensitivity. This is the first randomized, controlled study to explore the efficacy and safety of relacorilant (RELA), a selective GR modulator, in combination w/ nab-paclitaxel (nab-pac) compared to nab-pac alone.

Methods

Women w/ recurrent platinum-resistant/refractory high grade serous or endometroid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma w/ measurable or non-measurable disease and up to 4 chemotherapeutic regimens were 1:1:1 randomized to: -CONTINUOUS 100mg RELA daily (w/discretionary escalation to 150mg) + 80mg/m2 nab-pac on days 1, 8, and 15 of a q28-day schedule; or -INTERMITTENT 150mg RELA the day before, of, and after 80mg/m2 nab-pac on days 1, 8, and 15, of a q28-day schedule; or -COMPARATOR,100mg/m2 nab-pac on days 1, 8, and 15, of a q28-day schedule. A lower nab-pac dose was used with RELA because RELA inhibits the metabolism of nab-pac. The primary endpoint was progression-free survival (PFS) determined by the investigator per RECIST 1.1.

Results

178 women were randomized. At median follow-up of 11.07 mos, the INTERMITTENT regimen significantly improved median PFS compared to nab-pac alone (HR, 0.66, 95%CI 0.44-0.98, log-rank test p=0.038). While ORR was similar, Duration of Response (DoR) was significantly improved (HR 0.36, 95% 0.16-0.77, p=0.006) in the INTERMITTENT regimen vs. nab-pac alone. Overall survival will be assessed at maturity. Most common grade ≥3 adverse events were neutropenia, anemia, and peripheral sensory neuropathy. Table: 721O

CONTINUOUS RELA + Nab-Pac N=58 INTERMITTENT RELA + Nab-Pac N=60 COMPARATOR Nab-Pac N=60
PFS Median, mos (95% CI) 5.29 (3.84, 5.55) 5.55* (3.68, 7.20) 3.76 (3.52, 5.36)
ORR % (95% CI) n=19 35.2 (22.68, 49.38) n=20 35.7 (23.36, 49.64) n=19 35.8 (23.14, 50.20)
DoR Median, mos (95% CI) 3.79 (2.33, 5.55) 5.55** (3.75, 5.88) 3.65 (2.89, 5.09)
*P<0.05 vs. Nab-Pac alone **P<0.01 vs. Nab-Pac alone
Grade 3+ TEAEs by Preferred term n,% n=57 n=60 n=60
Neutropenia 14 (24.6%) 4 (6.7%) 8 (13.3%)
Anemia 11 (19.3%) 8 (13.3%) 7 (11.7%)
Peripheral Sensory Neuropathy 9 (15.8%) 0 (0%) 3 (5.0%)
TEAEs=Treatment-Emergent Adverse Events

Conclusions

INTERMITTENT RELA + nab-pac improved PFS and had a favorable safety profile in recurrent platinum-resistant and/or platinum-refractory ovarian cancer patients.

Clinical trial identification

NCT03776812.

Editorial acknowledgement

Legal entity responsible for the study

Corcept Therapeutics.

Funding

Corcept Therapeutics.

Disclosure

N. Colombo: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Oncxe; Financial Interests, Personal, Speaker’s Bureau, Corcept Therapeutics: Novartis; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics. D.D. Nguyen: Financial Interests, Personal, Full or part-time Employment: Corcept Therapeutics. G.F. Fleming: Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Principal Investigator: Roche; Financial Interests, Personal, Principal Investigator: Syros; Financial Interests, Personal, Principal Investigator: GSK; Financial Interests, Personal, Principal Investigator: Iovance; Financial Interests, Personal, Principal Investigator: Sermonix; Financial Interests, Personal, Principal Investigator: Compugen; Financial Interests, Personal, Principal Investigator: Celldex; Financial Interests, Personal, Principal Investigator: Plexxicon; Financial Interests, Personal, Principal Investigator: AstraZeneca. R.N. Grisham: Financial Interests, Personal, Advisory Board: Signatera; Financial Interests, Personal, Advisory Board: Verastem; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: PER; Financial Interests, Personal, Advisory Board: Aptitude; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Principal Investigator: Context; Financial Interests, Personal, Principal Investigator: Verastem; Financial Interests, Personal, Principal Investigator: Bayer; Financial Interests, Personal, Principal Investigator: Pfizer; Financial Interests, Personal, Principal Investigator: Novartis. D. Lorusso: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Other, Travel Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Principal Investigator: Clovis; Financial Interests, Personal, Principal Investigator: Corcept Therapeutics; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Principal Investigator: GSK; Financial Interests, Personal, Other, Travel Grant: GSK; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Principal Investigator: MSD; Financial Interests, Personal, Advisory Board: Pharmamar; Financial Interests, Personal, Principal Investigator: Immonogen; Financial Interests, Personal, Principal Investigator: Genmab; Financial Interests, Personal, Other, Travel Grant: Roche. T. Van Gorp: Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: OncXerna; Financial Interests, Institutional, Advisory Board: Eisai; Financial Interests, Institutional, Principal Investigator: Amgen; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Corcept Therapeutics. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Deciphera; Financial Interests, Institutional, Principal Investigator: Abbvie Deutschland; Financial Interests, Institutional, Principal Investigator: Ability; Financial Interests, Institutional, Principal Investigator: Advaxis; Financial Interests, Institutional, Principal Investigator: Aeterna Zentaris. H.I. Pashova: Financial Interests, Personal, Full or part-time Employment: Corcept Therapeutics. A. Grauer: Financial Interests, Personal, Full or part-time Employment: Corcept Therapeutics.

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