Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

The objective of this study was to evaluate the efficacy and safety of alpelisib in combination with olaparib compared with single-agent cytotoxic chemotherapy in participants with platinum-resistant or platinum-refractory, germline BRCA non-mutated (gBRCAnm) high-grade serous ovarian cancer (HGSOC), with progression-free survival (PFS) as the primary efficacy endpoint.

Key Inclusion criteria: * Participant had histologically confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. * Measurable disease, i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation). * If no measurable disease was present, the disease was assessable by Gynecologic Cancer Intergroup criteria (GCIC) for CA-125. * Participant had no germline BRCA1/2 mutation as determined by an FDA-approved assay. * Participant had an ECOG performance status of 0 or 1. * Participant had platinum-resistant (progression within one to six months after completing platinum-based therapy) or platinum refractory disease (progression during treatment or within 4 weeks after the last dose), where platinum-based therapy was not an option, according to the Gynecologic Cancer Intergroup criteria (GCIG) 5th Ovarian Cancer Consensus Conference definitions. * Participant must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy was appropriate as the next line of treatment. * Participant had received prior bevacizumab or was not eligible to receive bevacizumab due to medical reasons. Key Exclusion criteria: * Participant had received prior treatment with any phosphoinositide 3-kinase, mammalian Target Of Rapamycin or Protein Kinase B inhibitor. * Participant was concurrently using other anti-cancer therapy. * Participant was in a state of small or large bowel obstruction or had other impairment of gastrointestinal (GI) function or GI disease. * Participant had surgery within 14 days prior to starting study drug or had not recovered from major adverse effects. * Participant had not recovered from all toxicities related to prior anticancer therapies to baseline or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade ≤1. Exception to this criterion: participants with any grade of alopecia were allowed to enter the study. * Participant had an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose and HbA1c. * Participants with liver impairment and Child Pugh score B or C. * Participant had received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who had not recovered to baseline, grade 1 or better from related adverse effects of such therapy (with the exception of alopecia). * Participant had known hypersensitivity to any of the study drugs or excipients. * Participant had a history of myelodysplastic syndrome or acute myeloid leukemia, or presented clinical and/ or laboratory features suggestive thereof. Other inclusion/exclusion criteria may apply