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197 What is the real-world risk of MDS/AML and other secondary primary malignancies in patients with epithelial ovarian cancer treated with niraparib maintenance treatment? Interim results from a regulatory safety study
  1. Stefan Kommoss1,
  2. Giulia Tasca2,
  3. Tirza Areli Calderón Boyle3,
  4. Amanda Golembesky4,
  5. Jeanne M Schilder5,
  6. Izabela A Malinowska6,
  7. Guilan Ye3,
  8. Judi Kuplast3,
  9. Jessica Perhanidis6,
  10. Zoe Zeliku7,
  11. Constanza Maximiano Alonso8 and
  12. Maurice Van Der Vorst9
  1. 1Diakoneo Diak Klinikum, Schwäbisch Hall, Germany
  2. 2Veneto Institute of Oncology IOV – IRCCS, Padua, Italy
  3. 3GSK, Upper Providence, USA
  4. 4GSK, Durham, USA
  5. 5GSK, Philadelphia, USA
  6. 6GSK, Waltham, USA
  7. 7GSK, Stevenage, UK
  8. 8Hospital Univeritario Puerta de Hierro-Majadahonda, Madrid, Spain
  9. 9Rijnstate hospital, Arnhem, The Netherlands


Introduction/Background Niraparib, a poly(ADP-ribose) polymerase inhibitor (PARPi), was approved in the EU in 2017 as maintenance treatment for platinum-sensitive recurrent (2LM+) ovarian cancer (OC) and in 2020 as first-line maintenance (1LM) following first-line platinum-based chemotherapy. Interim results from a prospective, noninterventional, single-arm, regulatory study characterising the risk of developing myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) and other secondary primary malignancies (SPMs) of patients treated with niraparib in routine clinical practice are presented.

Methodology Adult patients diagnosed with epithelial OC from Germany, Italy, Netherlands, and Spain who received niraparib maintenance treatment were enroled. Patients were followed from niraparib initiation (index date) to the earliest of study completion at 5 years’ follow-up, study discontinuation, death, or data cutoff (10Feb2023). MDS/AML, other SPMs, and treatment-emergent adverse events (TEAEs) incidence were summarised. Analyses were stratified by niraparib use in 1LM or 2LM+ setting.

Results As of 10Feb2023, 740 patients (174 1LM; 566 2LM+) were enroled and met analytic cohort criteria (median age, 65 years; 90% stage III/IV high-grade serous OC at diagnosis; 14.4% BRCA-mutated. Follow-up was ongoing for 62.7% of patients. Median (Q1, Q3) duration of niraparib treatment was 6.6 (3.3, 11.5) and 9.3 (4.1, 20.5) months in 1LM and 2LM+ cohorts, respectively, reflecting the study’s ongoing nature. A total of 8 patients (1.1%) experienced 10 MDS/AML events, and 4 patients (0.5%) experienced a total of 5 SPMs (table 1). All events occurred in the 2LM+ cohort. Overall, 44.1% (n=326) of patients experienced at least 1 TEAE, 15.4% (n=114) had a grade ≥3 TEAE, and 7.4% (n=55) experienced a serious TEAE.

Conclusion The regulatory interim analysis results are consistent with niraparib’s known safety profile. For all safety outcomes, including MDS/AML and other SPMs, observed event rates were lower than those reported in niraparib clinical trials and label. No new safety signals were observed.

Disclosures This study (OneCDP213705) was sponsored by GSK (Waltham, MA, USA). Syneos Health received consulting fees to conduct this study.

Abstract 197 Table 1

Incidence rates of MDS/AML and other SPMS

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