You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

Bexsero

Product menu

ZEJULA offers patients proven efficacy without compromising their quality of life*1–4

Learn more about the Phase III PRIMA and PRIME studies in 1L maintenance for advanced ovarian cancer5,6

*Based on exploratory and post hoc analyses, results should be interpreted with caution.

How ZEJULA works

Poly(ADP-ribose)polymerase (PARP) is a protein that plays a role in DNA repair.7

ZEJULA is an inhibitor of PARP1 and PARP2.7

In vitro studies suggest that the cytotoxic effects of ZEJULA may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death.7

Indication

ZEJULA is indicated as monotherapy for:7

  • The maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
  • The maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

The only approved 1L maintenance monotherapy proven in two Phase III clinical trials: PRIMA and PRIME2,5,6

PRIMA Study design:

*PRIMA was a Phase III, randomised, double-blind, placebo-controlled, multicentre study of ZEJULA maintenance treatment in patients with advanced ovarian cancer following response on front-line platinum-based chemotherapy. Long-term investigator-assessed PFS is an ad hoc endpoint. PFS in overall population and HRd patients by BICR at 2 years were co- primary endpoints of the PRIMA study: overall population HR: 0.62 (95% Cl: 0.50, 0.76, p<0.001): HRd population HR: 0.43(95% Cl: 0.31, 0.59, p<0.001).With 3.5-year median follow-up, the most common AEs (Grades 1-4) in ≥20% of all patients in PRIMA receiving ZEJULA were: thrombocytopenia (67%), anaemia (65%), nausea (58%), neutropenia (43%), constipation (42%), fatigue (37%), headache (28%), insomnia (26%), abdominal pain (25%), vomiting (24%), arthralgia (21%), hypertension (21%), and diarrhoea (20%).1,2

SEE STUDY DESIGN


ZEJULA more than doubled the 4-year PFS rates observed in HRd patients vs. placebo*†2

Reduction in risk of progression or death remained consistent with the primary analysis*†2,5

PFS in the HRd population at 3.5-year median follow upa2

PRIMA_PFS in HRd pop graph

PFS in the overall population at 3.5-year median follow upa2

PRIMA_PFS in overall pop at 3.5 yr follow-up graph

Helping protect your patients from progression in the long term2

*PFS in HRd patients and overall population by BICR were co-primary endpoints of the PRIMA study: HRd population HR: 0.43 (95% CI: 0.31, 0.59, p<0.001); overall population HR: 0.62 (95% CI: 0.50, 0.76, p<0.001).5

†Long-term investigator-assessed PFS is an exploratory ad hoc endpoint, based on estimates from the 3.5-year median follow-up Kaplan-Meier curve.


Individualised starting dosing

ZEJULA is the only 1L maintenance PARPi monotherapy approved with individualised dosing from the start7,10,11

Starting dose:

200mg dosing icon

If baseline weight: <77 kg, or platelets <150,000/μl

Starting dose:

300mg dosing icon

If baseline weight: ≥77 kg, and platelets ≥150,000/μl

Tailored dosing from the start, while maintaining efficacy‡7,12

Risk of progression or death with an individualised vs. fixed starting dose of ZEJULA (BICR):a12

HRd patients12

61% lower icon

Individualised starting dose

HR 0.39 (95% CI: 0.22, 0.72)
vs. fixed starting dose
HR: 0.44 (95% CI: 0.30, 0.64)
in the HRd population

Overall patient population12

31% lower_icon

Individualised starting dose

HR 0.69 (95% CI: 0.48, 0.98)
vs. fixed starting dose
HR: 0.59 (95% CI: 0.46, 0.76)
in the overall population

aFollowing a protocol amendment, 35% of all patients in PRIMA (n=255/733) received an individualised starting dose.5 This is the approved dosing regimen for ZEJULA in 1L maintenance.7 Exploratory analyses, results should be interpreted with caution. Because of limited follow‐up time by primary data cut-off date among patients who received the ISD regimen, an updated data cut was taken on November 17, 2019 (6 months after the primary data cut), to perform an ad hoc analysis of PFS by IA with increased follow‐up time and event maturity. Data cut-off for the BICR analysis was May 2019.12

You may be able to maintain efficacy and reduce rates of certain Grade ≥3 side effects, with individualised dosing2,12

‡Exploratory endpoint from the primary analysis. Results should be interpreted with caution.

SEE STUDY DESIGN

In PRIME, efficacy was observed in both the overall and HRd populations†‡6

PRIME_PFS graph
PRIME_PFS in HRd pop

Supporting the efficacy of niraparib in 1L maintenance6

†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.6,8,9 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.
‡At 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.6,8

With ZEJULA, an established safety profile means you know what they may experience2,5

Low TEAE-related discontinuation rates and AE profile maintained over long-term follow-up2,5

TEAEs
 ZEJULA (n=484)
    Placebo (n=244)
Any TEAE 99% 94%

Grade ≥3

 73% 23%
Led to treatment discontinuationa 14% 3%
Led to dose reduction 72% 9%
Led to dose interruption 80% 21%
Led to death 1% 1%

Adapted from González-Martín et al. 2023.
aIncludes two additional patients who received ZEJULA and experienced a TEAE leading to a dose interruption and subsequently discontinued treatment; also includes one patient in the placebo group who experienced the adverse event ascites at the time of disease progression and was recorded as discontinuing treatment because of disease progression.

In PRIMA, no new safety signals were reported at 3.5-year median follow-up2

Niraparib treatment in PRIME had a low TEAE-related discontinuation rate of <7%†6

  • The most common all- and Grade ≥3 TEAEs were haematological and gastrointestinal16
  • 6.7% TEAE-related discontinuation rate with niraparib, similar to placebo (5.4%)6
  • In the niraparib arm, TEAE-related interruptions or dose reductions affected 62.7% and 40.4% of niraparib patients, and 19.4% and 6.2% of placebo patients, respectively6,16
PRIME safety graph

In PRIME, all patients received individualised dosing prospectively6

†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.6,8,9 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.

Improved tolerability was observed with tailored dosing from the start in 1L maintenance2,7,12

ZEJULA offers your patients the confidence of a proven long-term safety profile2

The tolerability of niraparib has been established in multiple clinical studies2,5,6,13–15

PRIMA long-term safety graph

Individualised starting dosing may help you get ahead of certain side effects12

aMDS/AML incidence rate was the same for both ZEJULA- and placebo-treated patients (1.2%). The majority of patients who experienced MDS/AML events had undergone additional chemotherapy and/or PARPi therapy.2

Tailoring dosing from the start may reduce their risk of certain AEs2,12

In patients receiving an individualised vs. fixed starting dose:

  • All common TEAEs (≥20%) were less frequently reported2
  • The rates of certain Grade ≥3 haematological AEs were reduced, including thrombocytopenia, anaemia and neutropenia2,12
PRIMA individualised dosing safety graph

Choose the only approved 1L PARPi with individualised dosing from the start7

Learn more about ZEJULA in 1L maintenance

tablet icon

Dosing & treatment management

LEARN MORE
stylised graphic

Expert Perspectives

HEAR PERSPECTIVES
ZEJULA patient starter kit

Access the Patient Starter Kit

CLICK HERE

All imagery shown depicts hypothetical patients only.

Zejula Safety Information7:

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.

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; AE, adverse event; ALT, alanaine transaminase; AST, aspartate transaminase; BICR, blinded independent central review; CI, confidence interval; DNA, deoxyribonucleic acid; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; FSD, fixed starting dose; FOSI, Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index; HR, hazard ratio; HRD, homologous recombination deficiency; HRd, homologous recombination deficient; HRQoL, health-related quality of life; ISD, individualised starting dose; NE, not estimable; NR, not reached; PARP, poly(ADP-ribose) polymerase; PARPi, PARP inhibitor; PFS, progression-free survival; SE, standard error; TEAE, treatment-emergent AE.

References

  1. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402. Supplementary appendix.
  2. González-Martín A, et al. Eur J Cancer. 2023; 189:112908.
  3. Barretina-Ginesta M-P, et al. Ther Adv Med Oncol. 2022;14:1–13.
  4. 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.
  5. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  6. Li N, et al. JAMA Oncol. 2023. doi:10.1001/jamaoncol.2023.2283.
  7. ZEJULA (niraparib). prescribing information
  8. Li N, et al. JAMA Oncol. 2023. doi:10.1001/jamaoncol.2023.2283. Protocol.
  9. GSK, Inc. Data on file. 2022. 2022N505277_00.
  10. Lynparza (olaparib), Summary of Product Characteristics.
  11. Rubraca (rucaparib), Summary of Product Characteristics.
  12. Mirza MR, et al. Cancer. 2023;129(12):1846–1855.
  13. Mirza MR, et al. N Engl J Med. 2016;375(22):2154–2164.
  14. Moore KN, et al. Lancet Oncol. 2019;20(5):636–648.
  15. Wu XH, et al. Ann Oncol. 2021;32(4):512–521.
  16. Li N, et al. JAMA Oncol. 2023. doi:10.1001/jamaoncol.2023.2283. Supplementary Appendix.

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
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
www.moh.gov.om : الموقع االكتروني

Trademarks are owned by or licensed to the GSK group of companies.
©2024 GSK group of companies or its licensor. All rights reserved. 

PM-RCH-NRP-SRCH-240001 | August 2024