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2 results on '"Pashova, H"'

1. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study

Author

Colombo, N, Van Gorp, T, Matulonis, U, Oaknin, A, Grisham, R, Fleming, G, Olawaiye, A, Nguyen, D, Greenstein, A, Custodio, J, Pashova, H, Tudor, I, Lorusso, D, Colombo, Nicoletta, Van Gorp, Toon, Matulonis, Ursula A, Oaknin, Ana, Grisham, Rachel N, Fleming, Gini F, Olawaiye, Alexander B, Nguyen, Dorothy D, Greenstein, Andrew E, Custodio, Joseph M, Pashova, Hristina I, Tudor, Iulia C, Lorusso, Domenica, Colombo, N, Van Gorp, T, Matulonis, U, Oaknin, A, Grisham, R, Fleming, G, Olawaiye, A, Nguyen, D, Greenstein, A, Custodio, J, Pashova, H, Tudor, I, Lorusso, D, Colombo, Nicoletta, Van Gorp, Toon, Matulonis, Ursula A, Oaknin, Ana, Grisham, Rachel N, Fleming, Gini F, Olawaiye, Alexander B, Nguyen, Dorothy D, Greenstein, Andrew E, Custodio, Joseph M, Pashova, Hristina I, Tudor, Iulia C, and Lorusso, Domenica

Abstract

PURPOSE: Despite therapeutic advances, outcomes for patients with platinum-resistant/refractory ovarian cancer remain poor. Selective glucocorticoid receptor modulation with relacorilant may restore chemosensitivity and enhance chemotherapy efficacy. METHODS: This three-arm, randomized, controlled, open-label phase II study (ClinicalTrials.gov identifier: NCT03776812) enrolled women with recurrent, platinum-resistant/refractory, high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer, or ovarian carcinosarcoma treated with ≤4 prior chemotherapeutic regimens. Patients were randomly assigned 1:1:1 to (1) nab-paclitaxel (80 mg/m2) + intermittent relacorilant (150 mg the day before, of, and after nab-paclitaxel); (2) nab-paclitaxel (80 mg/m2) + continuous relacorilant (100 mg once daily); or (3) nab-paclitaxel monotherapy (100 mg/m2). Nab-paclitaxel was administered on days 1, 8, and 15 of each 28-day cycle. The primary end point was progression-free survival (PFS) by investigator assessment; objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety were secondary end points. RESULTS: A total of 178 women were randomly assigned. Intermittent relacorilant + nab-paclitaxel improved PFS (hazard ratio [HR], 0.66; log-rank test P = .038; median follow-up, 11.1 months) and DOR (HR, 0.36; P = .006) versus nab-paclitaxel monotherapy, while ORR was similar across arms. At the preplanned OS analysis (median follow-up, 22.5 months), the OS HR was 0.67 (P = .066) for the intermittent arm versus nab-paclitaxel monotherapy. Continuous relacorilant + nab-paclitaxel showed numerically improved median PFS but did not result in significant improvement over nab-paclitaxel monotherapy. Adverse events were comparable across study arms, with neutropenia, anemia, peripheral neuropathy, and fatigue/asthenia being the most common grade ≥3 adverse events. CONCLUSION: Intermittent relacorilant + nab-paclitaxel improved

Published
2023

2. Relacorilant plus nab-paclitaxel for the treatment of metastatic pancreatic ductal adenocarcinoma: results from the open-label RELIANT study.

Author

Borazanci EH, Bahary N, Chung V, Huyck TK, Kio EA, Chiorean EG, Skeel RT, Alese OB, Cardin DB, Fountzilas C, Hanna WT, Leal AD, Lee V, Noonan AM, Philip PA, Wainberg ZA, Pashova H, Mann G, and Oberstein PE

Subjects
Humans, Female, Male, Middle Aged, Aged, Adult, Neoplasm Metastasis, Aged, 80 and over, Paclitaxel therapeutic use, Paclitaxel administration & dosage, Paclitaxel adverse effects, Paclitaxel pharmacology, Albumins administration & dosage, Albumins therapeutic use, Albumins adverse effects, Albumins pharmacology, Carcinoma, Pancreatic Ductal drug therapy, Carcinoma, Pancreatic Ductal pathology, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Antineoplastic Combined Chemotherapy Protocols adverse effects
Abstract

Background: Modulation of glucocorticoid receptor (GR) activity in tumor cells enhances chemotherapy efficacy. We evaluated the selective GR modulator relacorilant plus nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who had received at least 2 prior therapy lines., Patients and Methods: In this open-label, single-arm, phase III study, patients received once-daily oral relacorilant (100 mg, titrated to 150 mg in 25 mg increments/cycle) and nab-paclitaxel (80 mg/m2) on days 1, 8, and 15 of 28-day cycles. The primary efficacy endpoint was objective response rate (ORR) by blinded independent central review. Progression-free survival (PFS), overall survival (OS), target gene modulation, and safety were also assessed., Results: Of 43 patients enrolled, 31 were evaluable for ORR (12 did not reach first postbaseline radiographic assessment). An interim analysis to assess whether ORR was ≥10% showed no confirmed responses and the study was discontinued. Two (6.5%) patients attained unconfirmed partial responses and 15 (48.4%) had stable disease. Fourteen of 31 (45.2%) patients had reductions in target lesion size, despite prior nab-paclitaxel exposure in 12 of the 14. Median PFS and OS were 2.4 months (95% CI, 1.4-4.2) and 3.9 months (95% CI, 2.8-4.9), respectively. The most common adverse events were fatigue and nausea. RNA analysis confirmed that relacorilant plus nab-paclitaxel suppressed 8 cortisol target genes of interest., Conclusion: Relacorilant plus nab-paclitaxel showed modest antitumor activity in heavily pretreated patients with mPDAC, with no new safety signals. Studies of this combination in other indications with a high unmet medical need are ongoing., (© The Author(s) 2024. Published by Oxford University Press.)

Published
2024
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