Lifyorli (relacorilant) / Corcept Therap - LARVOL DELTA

ROSELLA: Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (clinicaltrials.gov) - P3 | N=381 | Active, not recruiting | Sponsor: Corcept Therapeutics | Trial completion date: Mar 2026 ➔ Dec 2026

Monotherapy • Platinum resistant • Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Pooled Safety Analysis of Relacorilant plus Nab-paclitaxel in Patients with Platinum-resistant Ovarian Cancer (PROC) Enrolled to ROSELLA and Study 552 (ESMO 2026) - No abstract available

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Meta-analysis of Relacorilant plus Nab-paclitaxel Efficacy in Patients with Platinum-resistant Ovarian Cancer (PROC) Enrolled to ROSELLA and Study 552 (ESMO 2026) - No abstract available

Platinum resistant • Retrospective data • Oncology • Ovarian Cancer • Solid Tumor

PHASE 3 ROSELLA (GOG-3073, ENGOT-OV72) TRIAL OF RELACORILANT + NAB-PACLITAXEL VS NAB-PACLITAXEL IN PLATINUM-RESISTANT OVARIAN CANCER: PRIMARY RESULTS AND OUTCOMES IN OLDER PATIENTS (IGCS 2025) - "The addition of relacorilant to nab-paclitaxel showed a statistically significant improvement in PFS by BICR and a clinically meaningful benefit in OS at the interim analysis (Table). Patients aged ≥65 were heavily pretreated, had advanced disease, and were similarly distributed between treatment arms (38.3% vs 41.5%). The addition of relacorilant was associated with a 39% reduction in the risk of progression in this subgroup (PFS by BICR: HR 0.61 [95% CI 0.40-0.94] P=0.0247)."

Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023). (ASCO 2026) - P3 | "ROSELLA met both dual primary endpoints. Relacorilant plus nab-paclitaxel demonstrated a statistically and clinically significant OS benefit in patients with PROC compared to a weekly taxane, the most efficacious chemotherapy. Subgroup analyses for OS showed a consistent benefit favoring the addition of relacorilant to nab-paclitaxel irrespective of prior taxane use."

Clinical • Monotherapy • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

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. (ASCO 2022) - P2, P3 | "In addition to the improved PFS and DOR observed at the primary analysis, the OS analysis confirmed the survival benefit of intermittent RELA + NP compared to NP only, particularly in patients who were not primary platinum refractory. A phase 3 trial evaluating intermittent RELA + NP vs investigator’s choice of chemotherapy in patients without primary platinum-refractory disease is ongoing (NCT05257408)."

Clinical • Late-breaking abstract • P2 data • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • RELA

ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). (ASCO 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Relacorilant + nab-paclitaxel is the first treatment regimen to demonstrate a PFS and OS benefit in patients with PROC compared to a weekly taxane, the most efficacious comparator. These positive efficacy data and a favorable safety profile position relacorilant + nab-paclitaxel as a new standard for patients with PROC, without the need for biomarker selection."

Clinical • Combination therapy • Late-breaking abstract • Monotherapy • P3 data • Platinum resistant • Anemia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

Final Overall Survival (OS) Results From the Phase 3 ROSELLA Trial: Relacorilant Plus Nab-Paclitaxel vs Nab-Paclitaxel Monotherapy in Patients With Platinum-Resistant Ovarian Cancer (PROC) (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223) (SGO 2026) - No abstract available

Clinical • Late-breaking abstract • Monotherapy • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): Secondary endpoints (ESMO-GC 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Editorial acknowledgement Medical writing support was provided by Farida Khan, PhD, CMPP, an employee of Corcept Therapeutics Incorporated. Legal entity responsible for the study Corcept Therapeutics."

P3 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

ASCO Issues First Living Guideline for Recurrent Ovarian Cancer Treatment:…What does the guideline recommend for platinum-resistant recurrence? (Cancer Network) - "For platinum-resistant or platinum-refractory ovarian cancer, the panel strongly recommends mirvetuximab soravtansine for patients with high-grade disease and validated folate receptor alpha (FRα) expression by immunohistochemistry, based on OS and PFS benefits demonstrated in the phase 3 MIRASOL trial (NCT04209855). Other strongly recommended options include PLD monotherapy, bevacizumab plus chemotherapy, and paclitaxel on either a weekly or every-3-week schedule. The combination of relacorilant (Lifyorli) and nab-paclitaxel received a conditional recommendation based on data from the phase 3 ROSELLA trial (NCT05257408)."

Living guideline • Platinum resistant • Ovarian Cancer

FINAL OVERALL SURVIVAL RESULTS FROM THE PHASE 3 ROSELLA TRIAL: RELACORILANT PLUS NAB-PACLITAXEL VS NAB-PACLITAXEL MONOTHERAPY IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2026) - "At a median follow-up of 24.8 months, relacorilant plus nab-paclitaxel resulted in a 35% reduction in risk of death (HR 0.65; 95% CI, 0.51 to 0.83; P=0.0004). Median OS improved by 4.1 months (16.0 vs 11.9 months). OS favored the combination across all subgroups."

Clinical • Monotherapy • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Corcept Therapeutics Incorporated…announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. (Businesswire) - "The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone....The EC will review the CHMP's opinion and issue a final decision regarding approval in the fourth quarter of 2026."

CHMP • EMA approval • Platinum resistant • Ovarian Cancer

ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): Relacorilant + nab-paclitaxel in the subgroup of patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor (ESMO 2025) - P3 | "Table: LBA45 Efficacy summary ITT Prior PARPi Relacorilant + nab-paclitaxel N=188 Nab-paclitaxel N=193 Relacorilant + nab-paclitaxel n=114 Nab-paclitaxel n=120 PFS (BICR) Events , n (%) 113 (60.1) 121 (62.7) 66 (57.9) 72 (60.0) Median , months 6.54 5.52 7.36 4.63 HR (95% CI) 0.70 (0.54-0.91) 0.60 (0.42-0.85) P-value (Log-rank) P=0.0076 Nominal P=0.0035 OS (Interim) Events , n (%) 82 (43.6) 110 (57.0) 51 (44.7) 65 (54.2) Median , months 15.97 11.50 15.61 12.58 HR (95% CI) 0.69 (0.52-0.92) 0.77 (0.53-1.13) P-value (Log-rank) P=0.0121 Nominal P=0.1834 Conclusions In patients with PROC previously exposed to a PARPi, relacorilant + nab-paclitaxel showed clinically meaningful improvements in PFS and OS. The median PFS of 7.36 months compares favorably to the median time from first to second subsequent therapy in patients who progressed while receiving a PARPi in the PAOLA1 trial (Ann Oncol 2025; 36:185) and supports further exploration of relacorilant to improve outcomes..."

Clinical • Late-breaking abstract • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer

Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet) - P3 | "The addition of relacorilant to nab-paclitaxel prolonged progression-free survival and interim results also showed an improvement in overall survival. Together, the results position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with platinum-resistant ovarian cancer."

Journal • P3 data • Platinum resistant • Carcinosarcoma • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor

THE ROLE OF THE GLUCOCORTICOID RECEPTOR IN ENDOMETRIAL CANCER PATHOLOGY AND ITS MANAGEMENT (IGCS 2026) - "Emerging evidence, including trials of GR modulators (e.g., relacorilant in the ROSELLA trial), supports GR as a potential therapeutic target... There was a significant effect of cell type on nuclear GR expression (p=0.0088) with a significant increase in GR H -score on immune cells (59.70±46.55), compared to tumour (31.68±47.32, p=0.0277) and stromal cells (20.31±18.33, p=0.0172). Tumour cells were predominantly GR -negative. There was a significant effect of cell type on nucleus -to- cytoplasm ratio (p=0.0058), with stromal cells being highest (35.24±44.98), suggesting relatively increased GR activation compared to immune and tumour cells."

Endometrial Cancer • Oncology • Solid Tumor • NR3C1

Antibody-drug conjugates and beyond in platinum-resistant ovarian cancer: A comprehensive review of emergent strategies. (PubMed, Ther Adv Med Oncol) - "By selectively delivering potent cytotoxic payloads to tumor cells, ADCs such as mirvetuximab soravtansine (MIRV), targeting FRα, and trastuzumab deruxtecan (T-DXd), targeting HER2, have demonstrated clinically meaningful activity in selected populations...Beyond ADCs, other systemic approaches have demonstrated survival improvements in PROC even in biomarker-unselected populations, including the addition of the glucocorticoid receptor antagonist relacorilant to nab-paclitaxel and immune-chemotherapy combinations such as pembrolizumab plus paclitaxel with or without bevacizumab. Future directions aim to prioritize synergistic combinations to overcome resistance. This includes pairing ADCs with replication stress inhibitors like ATR inhibitors and WEE1 inhibitors or integrating them with next-generation immuno-oncology platforms such as bispecifics, T-cell engagers, and cancer vaccines, as well as the integration of dynamic biomarkers and quantitative tools to define..."

IO biomarker • Journal • Platinum resistant • Review • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • HER-2 • PROC

The Committee adopted the CHMP recommendation and scientific discussion, together with a list of questions for the applicant. (European Medicines Agency) - CHMP Final Minutes of the meeting on 23 - 26 Feb 2026: CHMP discussed the issues identified in the application for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

CHMP • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Peritoneal Cancer

Relacorilant in Combination With Nab-Paclitaxel for the Treatment of Adults With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. (PubMed, Ann Pharmacother) - P1/2, P2, P3 | "Relacorilant represents a novel strategy for reversing chemoresistance in combination with NP alongside a manageable safety profile for heavily pretreated patients with platinum-resistant epithelial ovarian, fallopian tube, and primary peritoneal cancers."

Journal • Platinum resistant • Review • Fallopian Tube Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Thrombocytopenia

STELLA: Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=63 | Not yet recruiting | Sponsor: ARCAGY/ GINECO GROUP

New P2 trial • Cervical Cancer • Oncology • Solid Tumor • CD4

Corcept Therapeutics Announces Second Quarter Financial Results… (Businesswire) - "Revenue of $256.1 million, a 32 percent increase over the same period in 2025....Lifyorli product revenue of $47.6 million. Increase in 2026 revenue guidance to $1.1 - $1.2 billion. Net income of $43.0 million, compared to $35.1 million in second quarter 2025."

Sales • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Marketing Authorization Application (MAA) (Businesswire) - "European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer - Approval expected by the end of this year."

EMA approval • Platinum resistant • Ovarian Cancer

Relacorilant in Combination with Chemotherapy (Businesswire) - "(i) STELLA...: Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy), conducted in collaboration with ARCAGY-GINECO - Results expected by the end of next year; (ii) TRIDENT - Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 60 patients with pancreatic cancer - Results expected by the end of next year."

Enrollment status • P2 data • Cervical Cancer • Pancreatic Cancer

Corcept Therapeutics…Provides Corporate Update (Businesswire) - "(i) BELLA Part A - Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer - Results expected by the end of this year; (ii) BELLA Part B - Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor - Results expected by the end of next year; (iii) BELLA Part C - Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) - Results expected by the end of next year."

Enrollment status • P2 data • Platinum resistant • Platinum sensitive • Endometrial Cancer • Ovarian Cancer

Targeting glucocorticoid receptor signaling in platinum-resistant ovarian cancer: translational rationale and clinical advances following the ROSELLA trial. (PubMed, Oncol Rev) - "These findings have translated into clinical evaluation, culminating in the phase 3 ROSELLA trial, which reported that the addition of relacorilant, a SGRA, to nab-paclitaxel significantly improved progression-free and overall survival in patients with recurrent PROC. In this evidence-based review, we summarize the biological basis of GR signaling in ovarian cancer, evaluate the clinical evidence supporting SGRAs, and discuss key challenges for implementation, including biomarker development, safety considerations, and rational combination strategies with chemotherapy, PARP inhibitors, and immunotherapy. We also highlight critical considerations for future clinical trial design to optimize the integration of GR-targeted therapies into the management of ovarian cancer."

IO biomarker • Journal • Platinum resistant • Review • Oncology • Ovarian Cancer • Solid Tumor

Systemic Treatment of Ovarian Cancer Recurrence: ASCO Living Guideline, Version 2026.1.0. (PubMed, J Clin Oncol) - "For patients with recurrent platinum-sensitive EOC, clinicians should offer platinum-based combination regimens, specifically pegylated liposomal doxorubicin (PLD) plus carboplatin, paclitaxel plus carboplatin, or gemcitabine plus carboplatin. Bevacizumab may be added to a platinum-based doublet followed by bevacizumab maintenance. For patients who are not candidates for platinum-based therapy, clinicians may utilize recommendations for first-line treatment of patients with relapsed platinum-resistant disease. For patients with platinum-resistant or refractory EOC high-grade disease and validated folate receptor alpha (FRα) expression, mirvetuximab soravtansine is strongly recommended. Other recommended systemic options for this population include PLD monotherapy, paclitaxel (once weekly or once every three weeks), bevacizumab in combination with chemotherapy, or the combination of relacorilant and nab-paclitaxel; gemcitabine monotherapy remains a conditional..."

Journal • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1