Primary analysis of EPIK-O/ENGOT-ov61: alpelisib plus olaparib versus chemotherapy in platinum-resistant or platinum-refractory high-grade serous ovarian cancer without BRCA mutation
Purpose - Patients with platinum-resistant/platinum-refractory high-grade serous ovarian cancer (HGSOC) without a BRCA mutation have poor prognosis and limited treatment options. We report efficacy and biomarker data from EPIK-O, which investigated alpelisib + olaparib versus single-agent chemothera...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
September 10, 2025
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| In: |
Journal of clinical oncology
Year: 2025, Jahrgang: 43, Heft: 26, Pages: 2908-2917 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO-25-00225 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1200/JCO-25-00225 Verlag, kostenfrei, Volltext: https://ascopubs.org/doi/10.1200/JCO-25-00225 
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| Verfasserangaben: | Panagiotis A. Konstantinopoulos, MD, PhD ; Jae Weon Kim, MD, PhD ; Gilles Freyer, MD, PhD ; Jung Yun Lee, MD, PhD ; Lydia Gaba, MD ; Rachel N. Grisham, MD ; Nicoletta Colombo, MD, PhD ; Xiaohua Wu, MD, PhD ; Jalid Sehouli, MD ; Felipe Cruz, MD, PhD ; David Cibula, MD, PhD ; Bradley J. Monk, MD ; Gitte-Bettina Nyvang, MD ; Michael Friedlander, MBChB, PhD ; Domenica Lorusso, MD, PhD ; Els Van Nieuwenhuysen, MD, PhD ; Rozita Malik, MBBS ; Rosalind Glasspool, MD, PhD ; Christian Marth, MD, PhD ; Alexandra Leary, MD, PhD ; Alfonso Cortés-Salgado, MD; Claudio Zamagni, MD; Frederik Marmé, MD, PhD; Jozef Sufliarsky, MD, PhD; Patsy Hinson; Monica Zuradelli, MD; Craig Wang, PhD; Fei Su, PhD ; Ines Paule, PhD; Michelle Miller, MD, MPH; Ursula A. Matulonis, MD ; and Antonio Gonz ´alez-Mart´ın, MD, PhD |
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| 245 | 1 | 0 | |a Primary analysis of EPIK-O/ENGOT-ov61 |b alpelisib plus olaparib versus chemotherapy in platinum-resistant or platinum-refractory high-grade serous ovarian cancer without BRCA mutation |c Panagiotis A. Konstantinopoulos, MD, PhD ; Jae Weon Kim, MD, PhD ; Gilles Freyer, MD, PhD ; Jung Yun Lee, MD, PhD ; Lydia Gaba, MD ; Rachel N. Grisham, MD ; Nicoletta Colombo, MD, PhD ; Xiaohua Wu, MD, PhD ; Jalid Sehouli, MD ; Felipe Cruz, MD, PhD ; David Cibula, MD, PhD ; Bradley J. Monk, MD ; Gitte-Bettina Nyvang, MD ; Michael Friedlander, MBChB, PhD ; Domenica Lorusso, MD, PhD ; Els Van Nieuwenhuysen, MD, PhD ; Rozita Malik, MBBS ; Rosalind Glasspool, MD, PhD ; Christian Marth, MD, PhD ; Alexandra Leary, MD, PhD ; Alfonso Cortés-Salgado, MD; Claudio Zamagni, MD; Frederik Marmé, MD, PhD; Jozef Sufliarsky, MD, PhD; Patsy Hinson; Monica Zuradelli, MD; Craig Wang, PhD; Fei Su, PhD ; Ines Paule, PhD; Michelle Miller, MD, MPH; Ursula A. Matulonis, MD ; and Antonio Gonz ´alez-Mart´ın, MD, PhD |
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| 520 | |a Purpose - Patients with platinum-resistant/platinum-refractory high-grade serous ovarian cancer (HGSOC) without a BRCA mutation have poor prognosis and limited treatment options. We report efficacy and biomarker data from EPIK-O, which investigated alpelisib + olaparib versus single-agent chemotherapy in these patients. - Patients and Methods - EPIK-O was an open-label, phase III trial that randomly assigned patients with platinum-resistant/platinum-refractory HGSOC with no germline or known somatic BRCA mutation 1:1 to alpelisib 200 mg once daily + olaparib 200 mg twice daily or treatment of physician's choice (TPC; paclitaxel 80 mg/m2 once weekly or pegylated liposomal doxorubicin 40-50 mg/m2 once every 28 days). Patients had 1-3 previous systemic therapies. Previous bevacizumab was required (unless contraindicated); previous poly(adenosine diphosphate-ribose) polymerase inhibitors were allowed. Primary end point was progression-free survival (PFS) per RECIST 1.1 (blinded independent review committee [BIRC]). Secondary efficacy end points included overall response rate (ORR; per BIRC), duration of response (per BIRC), and overall survival (OS; key secondary end point). - Results - A total of 358 patients (alpelisib + olaparib [n = 180], TPC [n = 178]) were included. The median follow-up time was 9.3 months. At data cutoff (April 21, 2023), 33 (18.3%) and 30 (16.9%) patients remained on treatment with alpelisib + olaparib and TPC, respectively. The median PFS (BIRC) was 3.6 versus 3.9 months (hazard ratio [HR], 1.14 [95% CI, 0.88 to 1.48]; one-sided P = .84) for alpelisib + olaparib versus TPC. The ORR was 15.6% (95% CI, 10.6% to 21.7%) versus 13.5% (95% CI, 8.8% to 19.4%). The median OS was 10.0 versus 10.6 months (HR, 1.22; 95% CI, 0.87 to 1.71). The safety profile of alpelisib + olaparib was consistent with that observed for the individual agents. - Conclusion - The primary objective, PFS improvement, was not met in EPIK-O. No new or unexpected adverse events were observed. Biomarker analyses provided new insights for responders to alpelisib + olaparib. | ||
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| 700 | 1 | |a Matulonis, Ursula A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a González-Martín, Antonio |e VerfasserIn |4 aut | |
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