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

Summary

The objective of this study was to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

Timeline

Start

2021-07-22

Primary completion

2023-04-21

Completion

2026-01-19

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision”

registry Alpelisib 200mg + Olaparib 200mg vs Paclitaxel or Pegylated Liposomal Doxorubicin (PLD); p = 0.84; Hazard Ratio (HR) 1.142 (95% CI 0.882 to 1.478) NCT04729387 ↗

Publications

• Konstantinopoulos PA, Gonzalez-Martin A, Cruz FM, Friedlander M, Glasspool R, Lorusso D, Marth C, Monk BJ, Kim JW, Hinson P, Ajipa O, Pretre V, Han Y, Matulonis UA. EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). Future Oncol. 2022 Oct;18(31):3481-3492. doi: 10.2217/fon-2022-0666. Epub 2022 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	200 mg	Oral
Subject	Olaparib	Small molecule	200 mg	Oral
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Comparator	Pegylated liposomal doxorubicin	Unknown	40 mg/m2	Intravenous
Comparator	Pegylated liposomal doxorubicin	Unknown	50 mg/m2	Intravenous

Indications