Corcept Therapeutics Incorporated · NASDAQ:CORT
Corcept Therapeutics — ESMO 2021
17 slides from Corcept Therapeutics's conference presentation, September 2021
Slide 1: Relacorilant With Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer: Phase 2 Study
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 2 Study Domenica Lorusso1, Nicoletta Colombo2, Dorothy Nguyen3, Gini
Slide 2: Declaration of Interests
Declaration of Interests Domenica Lorusso • Employee: Gynecologic Oncology Unit Fondazione Policlinico Universitario Gemelli IRCCS • Consultant/Advisor: Astra Zeneca, GSK, MSD, Pharmamar, Clovis, Merck Serono, Novartis • Promotional Speaker: GSK, Clovis, Astra Zeneca • Investigator/Researcher: GSK,
Slide 3: Platinum-resistant Ovarian Cancer: A Great Unmet Medical Need
Platinum-resistant Ovarian Cancer: A Great Unmet Medical Need Platinum resistance occurs in virtually all patients with recurrent ovarian cancer1 10-15% Response rate to chemotherapy1 ► Therapy options are limited to sequential chemotherapy not previously administered and molecular targeted agents 3
Slide 4: Relacorilant May Enhance and/or Restore Chemotherapy Sensitivity
Relacorilant May Enhance and/or Restore Chemotherapy Sensitivity ► Physiological cortisol levels can suppress immune activation and tumor cell apoptosis by activating the glucocorticoid receptor (GR)1,2 ► Upon GR activation, tumor progression is obtained via activation of proliferative pathways (epi
Slide 5: Preclinical and Phase 1 Results Suggest a Synergy Between Relacorilant and Nab-paclitaxel
Preclinical and Phase 1 Results Suggest a Synergy Between Relacorilant and Nab-paclitaxel Preclinical findings: ► In vitro, relacorilant restored paclitaxel-induced tumor cell apoptosis, which was reduced by cortisol1 ► In xenograft models, under normal physiological glucocorticoid levels, GR antago
Slide 6: Phase 2 Study Design
Phase 2 Study Design Statistical assumptions • CONTINUOUS vs COMPARATOR: 91 PFS events to detect a HR=0.56 (median PFS increase from 3.8 to 6.8 mo) • INTERMITTENT vs COMPARATOR: 92 PFS events to detect a HR=0.7 (median PFS increase from 3.8 to 5.4 mo) Content of this presentation is copyright and re
Slide 7: Baseline Characteristics
Baseline Characteristics INTERMITTENT CONTINUOUS COMPARATOR Overall (N=60) (N=58) (N=60) (N=178) Age, median (range), years 60 (38, 81) 60 (45, 75) 61.5 (41, 81) 61 (38, 81) Refractory**, no. (%) 23 (38.3%) 20 (34.5%) 22 (36.7%) 65 (36.5%) Primary refractory, no (%) 7 (11.7%) 3 (5.2%) 1 (1.7%) 11 (6
Slide 8: Patient Disposition
Patient Disposition INTERMITTENT CONTINUOUS COMPARATOR Overall (N=60) (N=58) (N=60) (N=178) Safety population 60 57 60 177 Discontinuation of study druga, no. (%) 53 (88.3%) 54 (93.1%) 56 (93.3%) 163 (91.6%) Disease progression 40 (66.7%) 40 (69.0%) 47 (78.3%) 127 (71.3%) Adverse event 7 (11.7%) 9 (
Slide 9: INTERMITTENT Relacorilant + Nab-paclitaxel Improved Progression-Free Survival
INTERMITTENT Relacorilant + Nab-paclitaxel Improved Progression-Free Survival INTERMITTENT* CONTINUOUS COMPARATOR (N=60) (N=58) (N=60) Events, no. (%) 47 (78.3%) 50 (86.2%) 57 (95.0%) Median PFS, mo 5.55 5.29 3.76 (95% CI) (3.68, 7.20) (3.84, 5.55) (3.52, 5.36) HR vs 0.66 0.83 N/A Comparator (0.44,
Slide 10: INTERMITTENT Relacorilant + Nab-paclitaxel Improved Progression-Free Survival
INTERMITTENT Relacorilant + Nab-paclitaxel Improved Progression-Free Survival INTERMITTENT* CONTINUOUS COMPARATOR (N=60) (N=58) (N=60) Events, no. (%) 47 (78.3%) 50 (86.2%) 57 (95.0%) Median PFS, mo 5.55 5.29 3.76 (95% CI) (3.68, 7.20) (3.84, 5.55) (3.52, 5.36) HR vs 0.66 0.83 N/A Comparator (0.44,
Slide 11: INTERMITTENT Relacorilant + Nab-paclitaxel Improved Duration of Response
INTERMITTENT Relacorilant + Nab-paclitaxel Improved Duration of Response ORR n (%) 95% CI INTERMITTENT 20 (35.7%) (23.4, 49.6) CONTINUOUS 19 (35.2%) (22.7, 49.4) COMPARATOR 19 (35.8%) (23.1, 50.2) While ORR was similar, DoR was significantly improved in the INTERMITTENT regimen. HR 0.36, 95% CI (0.1
Slide 12: Trend Toward Improved Overall Survival in INTERMITTENT Arm
Trend Toward Improved Overall Survival Observed in the INTERMITTENT Arm in Interim Analysis (63% Maturity) INTERMITTENT CONTINUOUS COMPARATOR (N=60) (N=58) (N=60) Events, no. (%) 19 (31.7%) 27 (46.6%) 30 (50.0%) Median OS, mo 12.94 11.30 10.41 (95% CI) (9.13, ---) (7.59, ---) (8.41, 16.76) HR vs 0.6
Slide 13: Trend Toward Improved Overall Survival in INTERMITTENT Arm
Trend Toward Improved Overall Survival Observed in the INTERMITTENT Arm in Interim Analysis (63% Maturity) INTERMITTENT CONTINUOUS COMPARATOR (N=60) (N=58) (N=60) Events, no. (%) 19 (31.7%) 27 (46.6%) 30 (50.0%) Median OS, mo 12.94 11.30 10.41 (95% CI) (9.13, ---) (7.59, ---) (8.41, 16.76) HR vs 0.6
Slide 14: Safety and Tolerability: Most Frequently Reported Toxicity
Safety and Tolerability: Most Frequently Reported Toxicity (>10%) INTERMITTENT CONTINUOUS COMPARATOR n, % (N=60) (N=57) (N=60) Neutropeniaa 12 (20.0%) 22 (38.6%) 22 (36.7%) Grade ≥3 4 (6.7%) 15 (26.3%) 9 (15.0%) Febrile neutropenia (Grade 3)b 0 (0.0%) 0 (0.0%) 1 (1.7%) Anemiac 29 (48.3%) 37 (64.9%)
Slide 15: Baseline and Pharmacodynamic Biomarkers
Baseline and Pharmacodynamic Biomarkers ► mRNA expression was measured in 137 pre-treatment tumor ► Fold change in expression for a panel of 239 GR-agonist-inducible specimens across all three arms of the study genes was assessed in whole blood from baseline to C1D15 (pre- dose) ► All tested ovarian
Slide 16: Conclusions
Conclusions ► This study is the first randomized, controlled, phase 2 trial of relacorilant + nab-paclitaxel in patients with platinum-resistant/refractory ovarian, primary peritoneal, or fallopian tube cancer. ► In this heavily pretreated population (up to 5 lines of prior chemotherapy), substantia
Slide 17: Thanks to all those who contributed to this study!
Thanks to all those who contributed to this study! The study investigators: The study patients and their families. • Dr. Fleming • Dr. Duska • Dr. Pisano The University of Chicago University of Virginia - Emily IRCCS - Istituto Nazionale dei Medical Center Couric Clinical Cancer Center Tumori di Nap