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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

Poveda, Andrés ; Lheureux, Stéphanie ; Colombo, Nicoletta ; Cibula, David ; Elstrand, Mari ; Weberpals, Johanne ; Bjurberg, Maria LU ; Oaknin, Ana ; Sikorska, Magdalena and González-Martín, Antonio , et al. (2025) In Gynecologic Oncology 197. p.74-82
Abstract

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... (More)

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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type
Contribution to journal
publication status
published
subject
keywords
BRCA, Maintenance, Olaparib, Ovarian cancer
in
Gynecologic Oncology
volume
197
pages
9 pages
publisher
Academic Press
external identifiers
  • scopus:105003712257
  • pmid:40300425
ISSN
0090-8258
DOI
10.1016/j.ygyno.2025.04.580
language
English
LU publication?
yes
id
75dd3b23-882e-4956-8e05-d24b652a88bb
date added to LUP
2025-07-30 12:40:54
date last changed
2025-07-30 12:41:26
@article{75dd3b23-882e-4956-8e05-d24b652a88bb,
  abstract     = {{<p>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.</p>}},
  author       = {{Poveda, Andrés and Lheureux, Stéphanie and Colombo, Nicoletta and Cibula, David and Elstrand, Mari and Weberpals, Johanne and Bjurberg, Maria and Oaknin, Ana and Sikorska, Magdalena and González-Martín, Antonio and Madry, Radoslaw and Rubio Pérez, María Jesus and Ledermann, Jonathan and Romero, Ignacio and Özgören, Ozan and Barnicle, Alan and Marshall, Helen and Bashir, Zahid and Škof, Erik}},
  issn         = {{0090-8258}},
  keywords     = {{BRCA; Maintenance; Olaparib; Ovarian cancer}},
  language     = {{eng}},
  pages        = {{74--82}},
  publisher    = {{Academic Press}},
  series       = {{Gynecologic Oncology}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1016/j.ygyno.2025.04.580}},
  doi          = {{10.1016/j.ygyno.2025.04.580}},
  volume       = {{197}},
  year         = {{2025}},
}