Corcept Initiates Trial of Relacorilant Plus Nab-Paclitaxel and Bevacizumab in Patients With Platinum-Resistant Ovarian Cancer
Corcept Therapeutics (NASDAQ: CORT) has launched BELLA, a new Phase 2 trial evaluating the combination of relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer. The single-arm, open-label trial aims to enroll 90 women across approximately 50 sites in North America, Europe, and Asia-Pacific.
The trial builds on the success of their pivotal Phase 3 ROSELLA trial, where the combination of relacorilant and nab-paclitaxel demonstrated improved progression-free and overall survival without increasing side effects. BELLA will investigate whether adding bevacizumab to this combination could provide an additional treatment option for patients.
Corcept Therapeutics (NASDAQ: CORT) ha lanciato BELLA, un nuovo studio di fase 2 che valuta la combinazione di relacorilant con nab-paclitaxel e bevacizumab in pazienti con cancro ovarico resistente al platino. Lo studio a braccio singolo e aperto mira a reclutare 90 donne in circa 50 siti in Nord America, Europa e Asia-Pacifico.
Lo studio si basa sul successo del loro studio pivotale di fase 3 ROSELLA, dove la combinazione di relacorilant e nab-paclitaxel ha dimostrato un miglioramento della sopravvivenza libera da progressione e della sopravvivenza complessiva senza aumentare gli effetti collaterali. BELLA indagherà se l'aggiunta di bevacizumab a questa combinazione potrebbe fornire un'opzione di trattamento aggiuntiva per i pazienti.
Corcept Therapeutics (NASDAQ: CORT) ha lanzado BELLA, un nuevo ensayo de fase 2 que evalúa la combinación de relacorilant con nab-paclitaxel y bevacizumab en pacientes con cáncer de ovario resistente al platino. El ensayo, de un solo grupo y abierto, tiene como objetivo inscribir a 90 mujeres en aproximadamente 50 sitios en América del Norte, Europa y Asia-Pacífico.
El ensayo se basa en el éxito de su ensayo pivotal de fase 3 ROSELLA, donde la combinación de relacorilant y nab-paclitaxel demostró mejorar la supervivencia libre de progresión y la supervivencia general sin aumentar los efectos secundarios. BELLA investigará si agregar bevacizumab a esta combinación podría proporcionar una opción de tratamiento adicional para los pacientes.
Corcept Therapeutics (NASDAQ: CORT)는 백금 내성 난소암 환자를 대상으로 relacorilant과 nab-paclitaxel, bevacizumab의 조합을 평가하는 새로운 2상 시험 BELLA를 시작했습니다. 단일군 공개 시험은 북미, 유럽 및 아시아 태평양의 약 50개 사이트에서 90명의 여성을 등록하는 것을 목표로 하고 있습니다.
이 시험은 relacorilant과 nab-paclitaxel의 조합이 부작용을 증가시키지 않으면서 무진행 생존과 전체 생존을 개선한 3상 ROSELLA 시험의 성공을 기반으로 합니다. BELLA는 이 조합에 bevacizumab을 추가하는 것이 환자에게 추가 치료 옵션을 제공할 수 있는지 조사할 것입니다.
Corcept Therapeutics (NASDAQ: CORT) a lancé BELLA, un nouvel essai de phase 2 évaluant la combinaison de relacorilant avec nab-paclitaxel et bevacizumab chez des patientes atteintes d'un cancer de l'ovaire résistant au platine. Cet essai à bras unique et ouvert vise à recruter 90 femmes dans environ 50 sites en Amérique du Nord, en Europe et en Asie-Pacifique.
L'essai s'appuie sur le succès de leur essai pivot de phase 3 ROSELLA, où la combinaison de relacorilant et nab-paclitaxel a montré une amélioration de la survie sans progression et de la survie globale sans augmenter les effets secondaires. BELLA investiguera si l'ajout de bevacizumab à cette combinaison pourrait offrir une option de traitement supplémentaire pour les patientes.
Corcept Therapeutics (NASDAQ: CORT) hat BELLA gestartet, eine neue Phase-2-Studie, die die Kombination von Relacorilant mit Nab-Paclitaxel und Bevacizumab bei Patienten mit platinresistentem Ovarialkarzinom bewertet. Die einarmige, offene Studie zielt darauf ab, 90 Frauen an etwa 50 Standorten in Nordamerika, Europa und dem asiatisch-pazifischen Raum zu rekrutieren.
Die Studie baut auf dem Erfolg ihrer entscheidenden Phase-3-Studie ROSELLA auf, bei der die Kombination von Relacorilant und Nab-Paclitaxel eine verbesserte progressionsfreie und Gesamtüberlebensrate zeigte, ohne die Nebenwirkungen zu erhöhen. BELLA wird untersuchen, ob die Hinzufügung von Bevacizumab zu dieser Kombination eine zusätzliche Behandlungsoption für Patienten bieten könnte.
- Expansion of clinical pipeline with new Phase 2 trial
- Previous Phase 3 ROSELLA trial showed positive survival outcomes
- Large international trial scope across multiple regions
- Single-arm trial design may limit data conclusiveness
- Additional clinical trial expenses will increase R&D costs
BELLA is a single-arm, open-label trial with a planned enrollment of 90 women with recurrent, platinum-resistant ovarian cancer at approximately 50 sites in
“In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients’ progression-free and overall survival, without increasing their side effect burden,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “BELLA will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients an additional treatment option.”
About Relacorilant
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.
About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in
About Cortisol’s Role in Oncology
Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators and GR antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include statements concerning: our ROSELLA trial and the potential of relacorilant combined with nab-paclitaxel to benefit patients; our BELLA trial, including its enrollment, site locations and the potential of relacorilant combined with nab-paclitaxel and bevacizumab to benefit patients; relacorilant’s efficacy and safety in any clinical setting; its potential to receive regulatory approval; and the scope and protective power of our intellectual property and relacorilant’s orphan drug designation. We disclaim any intention or duty to update forward-looking statements made in this press release.
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Source: Corcept Therapeutics Incorporated
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