Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer
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ADIS DRUG EVALUATION
Apalutamide: A Review in Metastatic Castration‑Sensitive Prostate Cancer Sheridan M. Hoy1
© Springer Nature Switzerland AG 2020
Abstract Apalutamide (Erleada®) is an oral selective androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC). In a multinational, phase III study (TITAN) in this patient population, the addition of apalutamide (240 mg once daily) to androgen deprivation therapy (ADT) significantly improved median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining healthrelated quality of life (HR-QOL) and not substantially differing from placebo plus ADT in safety. Although mature OS data are awaited with interest, the addition of apalutamide to ADT extends the treatment options available for standard of care in adult men with mCSPC.
Apalutamide: clinical considerations as an add‑on therapy in metastatic castration‑sensitive prostate cancer Selective AR inhibitor Significantly prolongs median rPFS, median OS and the median time to cytotoxic chemotherapy Maintains HR-QOL and the safety profile, with rash being the most common grade ≥ 3 adverse event
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12838184. The manuscript was reviewed by: P. Barata, Tulane University School of Medicine, New Orleans, LA, USA; A. Jang, Tulane University School of Medicine, New Orleans, LA, USA; M. Marchioni, Urology Unit, Department of Medical, Oral and Biotechnological Sciences, G. D’Annunzio University of Chieti, Chieti, Italy. * Sheridan M. Hoy [email protected] 1
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1 Introduction Androgen derivation therapy (ADT; typically achieved through suppressing testicular androgen secretion) has long been the standard of care for patients with metastatic castration-sensitive prostate cancer (mCSPC) [1, 2]. However, despite an initial response to ADT, castration resistance invariably develops [2, 3]. In such patients, intracellular androgen levels are increased and the androgen receptor (AR) is overexpressed, suggesting an adaptive mechanism [2]. Such understanding has led to the development of androgen axis inhibitors [i.e. androgen synthesis inhibitors (e.g. abiraterone acetate plus prednisone) and AR inhibitors (e.g. apalutamide, enzalutamide)] [2–4], with recent studies in patients with mCSPC demonstrating improved survival benefits with additional androgen receptor suppression (i.e. ADT plus an androgen axis inhibitor) [4]. Oral apalutamide ( Erleada®) has recently been approved in the EU [5] and the USA [6] for the treatment of adult men with mCSPC, with this article reviewing pharmacological (summarized in Table 1), therapeutic efficacy and tolerability data relevant to its use in this patient population. Apaluta
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