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Maintenance olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1 and/or BRCA2 mutation: Final overall survival results from the OPINION trial

A. Poveda, S. Lheureux, N. Colombo, D. Cibula, M. Elstrand, J. Weberpals, M. Bjurberg, A. Oaknin, M. Sikorska, A. González-Martín, R. Madry, MJ. Rubio Pérez, J. Ledermann, I. Romero, O. Özgören, A. Barnicle, H. Marshall, Z. Bashir, E. Škof

. 2025 ; 197 (-) : 74-82. [pub] 20250428

Language English Country United States

Document type Journal Article, Clinical Trial, Phase III, Multicenter Study

Persistent link   https://www.medvik.cz/link/bmc25015459

OBJECTIVE: Maintenance olaparib demonstrated clinical activity for progression-free survival in patients without a germline BRCA1 and/or BRCA2 mutation (non-gBRCAm) who had platinum-sensitive relapsed ovarian cancer in the phase IIIb, open-label, single-arm, non-comparator, international OPINION trial (NCT03402841). We report final overall survival (OS; secondary endpoint), prespecified secondary endpoint updates and ad hoc OS analysis by homologous recombination deficiency (HRD) and somatic BRCAm (sBRCAm) status. METHODS: Patients with non-gBRCAm platinum-sensitive relapsed ovarian cancer, ≥2 prior lines of platinum-based chemotherapy, and in response following their last platinum-based chemotherapy received 300 mg olaparib tablets twice daily until disease progression or unacceptable toxicity. RESULTS: 279 patients were enrolled and treated. With a median follow-up in patients censored for OS of 33.1 months (data cut-off September 17, 2021), median OS was 32.7 months (95 % CI 29.5-35.3); the 24-month OS rate was 65.8 %. In ad hoc subgroup analyses, OS rates tended to be higher in patients with HRD-positive tumors; 24-month OS rates were 81.5 %, 74.2 %, 72.0 % and 55.8 % in the sBRCAm, HRD-positive including sBRCAm, HRD-positive excluding sBRCAm, and HRD-negative subgroups, respectively. Grade ≥ 3 treatment-emergent adverse events were reported in 82 patients (29.4 %), most commonly anemia (13.6 %). Overall, two cases of myelodysplastic syndrome were reported (no new cases since the primary analysis). CONCLUSION: These data provide additional evidence of olaparib as maintenance therapy in patients with non-gBRCAm platinum-sensitive relapsed ovarian cancer, with longer OS observed in those with HRD-positive tumors. The safety profile was consistent with the primary analysis and known safety profile of olaparib, with no new safety findings.

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$a OBJECTIVE: Maintenance olaparib demonstrated clinical activity for progression-free survival in patients without a germline BRCA1 and/or BRCA2 mutation (non-gBRCAm) who had platinum-sensitive relapsed ovarian cancer in the phase IIIb, open-label, single-arm, non-comparator, international OPINION trial (NCT03402841). We report final overall survival (OS; secondary endpoint), prespecified secondary endpoint updates and ad hoc OS analysis by homologous recombination deficiency (HRD) and somatic BRCAm (sBRCAm) status. METHODS: Patients with non-gBRCAm platinum-sensitive relapsed ovarian cancer, ≥2 prior lines of platinum-based chemotherapy, and in response following their last platinum-based chemotherapy received 300 mg olaparib tablets twice daily until disease progression or unacceptable toxicity. RESULTS: 279 patients were enrolled and treated. With a median follow-up in patients censored for OS of 33.1 months (data cut-off September 17, 2021), median OS was 32.7 months (95 % CI 29.5-35.3); the 24-month OS rate was 65.8 %. In ad hoc subgroup analyses, OS rates tended to be higher in patients with HRD-positive tumors; 24-month OS rates were 81.5 %, 74.2 %, 72.0 % and 55.8 % in the sBRCAm, HRD-positive including sBRCAm, HRD-positive excluding sBRCAm, and HRD-negative subgroups, respectively. Grade ≥ 3 treatment-emergent adverse events were reported in 82 patients (29.4 %), most commonly anemia (13.6 %). Overall, two cases of myelodysplastic syndrome were reported (no new cases since the primary analysis). CONCLUSION: These data provide additional evidence of olaparib as maintenance therapy in patients with non-gBRCAm platinum-sensitive relapsed ovarian cancer, with longer OS observed in those with HRD-positive tumors. The safety profile was consistent with the primary analysis and known safety profile of olaparib, with no new safety findings.
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$a Lheureux, Stéphanie $u Princess Margaret Hospital, Toronto, ON, Canada
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$a Colombo, Nicoletta $u University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy
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$a Cibula, David $u General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic
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$a Elstrand, Mari $u Oslo University Hospital, Norwegian Radium Hospital, Oslo, Norway
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$a Weberpals, Johanne $u Ottawa Hospital Research Institute, Ottawa, ON, Canada
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$a Bjurberg, Maria $u Skåne University Hospital, Lund University, Lund, Sweden
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$a Oaknin, Ana $u Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
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$a Sikorska, Magdalena $u Olsztyn Provincial Specialist Hospital, Olsztyn, Poland
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$a González-Martín, Antonio $u Cancer Center Clinica Universidad de Navarra, Madrid, Spain; CIMA, Pamplona, Spain
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$a Madry, Radoslaw $u Medical University Karol Marcinkowski, Poznań, Poland
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$a Rubio Pérez, María Jesus $u Hospital Universitario Reina Sofía, Córdoba, Spain
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$a Ledermann, Jonathan $u UCL Cancer Institute, University College London and UCL Hospitals, London, UK
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$a Romero, Ignacio $u IVO, Valencia, Spain
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$a Özgören, Ozan $u Oncology R&D, AstraZeneca, Cambridge, UK
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$a Barnicle, Alan $u Oncology R&D, AstraZeneca, Cambridge, UK
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$a Bashir, Zahid $u Oncology R&D, AstraZeneca, Cambridge, UK
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