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PRIMA and PRIME study designs
PRIMA was the pivotal Phase III study for ZEJULA in 1L maintenance for advanced ovarian cancer1,2
PRIMA enrolled patients with a CR or PR to platinum-based chemotherapy1,2
aHRd status assessed using the FDA-approved Myriad myChoice CDx as either BRCAm or GIS+ (GIS ≥42).3
bExploratory and post hoc analyses.
PRIME assessed niraparib maintenance in Chinese patients who responded to 1L platinum-based chemotherapy6
aAt the time of study initiation, no commercial HRD assay was approved in China; the laboratory-developed, unvalidated BGI HRD assay was used in PRIME, with an HRD scoring system set by BGI prospectively. gBRCA status was determined using the BGI Genomics assay.6,7
The PRIME study sponsored by Zai Lab (Shanghai) Co. was conducted in China, using independently manufactured niraparib capsules. The Zai Lab niraparib capsule has the same formulation composition as GSK’s ZEJULA capsule, with limited in vitro bioequivalence data available.6–8 Care should be taken when interpreting results due to possible differences between products, patient populations and standard of care. Cross-trial comparisons cannot be made.
All imagery shown depicts hypothetical patients only.
Zejula Safety Information2:
Contraindications:
Hypersensitivity to the active substances or to any of the excipients.
Special warnings and precautions:
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported. Discontinue if a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption.
Use with caution in patients on anticoagulants and medicinal products known to reduce the thrombocyte count hypertension, hepatic impairment.
Pregnancy/contraception:
Should not be used during pregnancy or in women of childbearing potential.
Adverse Events:
Very common: Urinary Tract Infections, thrombocytopenia, anaemia, neutropenia, leukopenia, decreased appetite, insomnia.
Please refer to the local prescribing information for a more detailed safety information.
Abbreviations
1L, first-line; BICR, blinded independent central review; BRCA, breast cancer susceptibility gene; BRCAm, BRCA mutated; CR, complete response; FDA, Food and Drug Administration; FIGO, International Federation of Gynecology and Obstetrics; FOSI, Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index; GIS, genomic instability score; HRD, homologous recombination deficiency; HRd, homologous recombination deficient; OS, overall survival; PFS, progression-free survival; PR, partial response; PRO, patient-reported outcome; Q-TWIST, Quality-adjusted Time Without Symptoms of Disease or Toxicity; TFST, time to first subsequent therapy.
References
- González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
- ZEJULA (niraparib) Prescribing Information.
- González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402. Supplementary appendix.
- Barretina-Ginesta M-P, et al. Ther Adv Med Oncol. 2022;14:1–13.
- Halla K, et al. Safety and patient-reported outcomes in patients receiving niraparib in the PRIMA/ ENGOT-OV26/GOG-3012 Trial. Oncology Nursing Society (ONS) Annual Congress; San Antonio, TX, USA, 29 April–3 May 2020. Poster abstract IGCS20_1131.
- Li N, et al. JAMA Oncol. 2023. doi:10.1001/jamaoncol.2023.2283.
- Li N, et al. JAMA Oncol. 2023. doi:10.1001/jamaoncol.2023.2283. Protocol.
- GSK, Inc. Data on file. 2022. 2022N505277_00.
For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
Gulf.ProductQualityComplaints@gsk.com
Department of Pharmacovigilance & Drug Information |
دائرة التيقظ و المعلومات الدوائية المديرية العامة للصيدلة و الرقابة الدوائية وزارة الصحة, سلطنة عمان 0096822357687 / 0096822357686 :هاتف 0096822358489 :فاكس pharma-vigil@moh.gov.om :البريد الالكتروني www.moh.gov.om :الموقع الالكتروني |
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PM-RCH-NRP-SRCH-240001 | April 2024
