Detalle Publicación

EPIK-O/ENGOT-OV61: Alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study)

Autores: Konstantinopoulos, P. A. (Autor de correspondencia); González Martín, Antonio; Melo-Cruz, F.; Friedlander, M.; Glasspool, R.; Lorusso, D.; Marth, C.; Monk, B. J.; Kim, J. W.; Hinson, P.; Ajipa, O.; Pretre, V.; Han, Y.; Matulonis, U. A.
Título de la revista: FUTURE ONCOLOGY
ISSN: 1479-6694
Volumen: 18
Número: 31
Páginas: 3481 - 3492
Fecha de publicación: 2022
Patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) have a poor prognosis, and their management represents a substantial unmet medical need. Preclinical data and results from a phase lb trial demonstrated the efficacy and tolerability of the combination of the specific phosphatidylinositol-3-kinase (P13K) inhibitor alpelisib plus the poly (adenosine diphosphateribose) polymerase (PARP) inhibitor olaparib in platinum-resistant, non-BRCA-mutated ovarian cancer. Here, we describe the study design and rationale for the phase III, multicenter, open-label, randomized, active-controlled EPIK-O/ENGOT-OV61 trial investigating alpelisib in combination with olaparib compared with standard-of-care chemotherapy in patients with platinum-resistant or -refractory HGSOC with no germline BRCA mutation. Progression-free survival (blinded independent review committee) is the primary end point. Overall survival is a key secondary end point.