EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study)
Panagiotis A Konstantinopoulos, Antonio Gonzalez-Martin, Felipe Melo Cruz, Michael Friedlander, Rosalind Glasspool, Domenica Lorusso, Christian Marth, Bradley J Monk, Jae-Weon Kim, Patsy Hinson, Olga Ajipa, Vincent Pretre, Yu Han, Ursula A Matulonis, Panagiotis A Konstantinopoulos, Antonio Gonzalez-Martin, Felipe Melo Cruz, Michael Friedlander, Rosalind Glasspool, Domenica Lorusso, Christian Marth, Bradley J Monk, Jae-Weon Kim, Patsy Hinson, Olga Ajipa, Vincent Pretre, Yu Han, Ursula A Matulonis
Abstract
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 Ib trial demonstrated the efficacy and tolerability of the combination of the α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib plus the poly(adenosine diphosphate-ribose) 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. Clinical Trial Registration:: NCT04729387 (ClinicalTrials.gov).
Keywords: PARP inhibitor; PI3K inhibitor; alpelisib; chemotherapy; high-grade serous ovarian cancer; olaparib; ovarian cancer.
Source: PubMed