REG - GSK PLC - GSK Update: Zejula 2L in US

GSKAnnouncement

11/11/2022 07:16

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RNS Number : 0664G  GSK PLC  11 November 2022

Issued: 11 November 2022, London UK

 

GSK provides an update on Zejula (niraparib) US prescribing information

 

 

 

GSK plc (LSE/NYSE: GSK) today provided an update that at the request of the US
Food and Drug Administration (FDA) it will restrict the second-line
maintenance indication for Zejula (niraparib) to only the patient population
with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut).
The US first-line indication of Zejula remains unchanged for the maintenance
treatment of adult patients with advanced epithelial ovarian, fallopian tube,
or primary peritoneal cancer who have a complete or partial response to
platinum-based chemotherapy.

 

This decision follows an FDA review of the final overall survival (OS)
analysis of the ENGOT-OV16/NOVA phase III trial, which served as the basis for
the approval of the second-line maintenance indication. In the final OS
results from the NOVA trial, the secondary endpoint of OS demonstrated a
hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort.

 

NOVA is a randomised, double-blind, placebo-controlled phase III trial of
niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor
for the maintenance treatment of women with platinum-sensitive recurrent
ovarian cancer. The primary endpoint of the NOVA study was progression-free
survival (PFS), evaluated as two independently powered cohorts (gBRCAmut and
non-gBRCAmut); results demonstrated the clinically meaningful and
statistically significant benefit of niraparib in both cohorts and across the
HRD subgroups in the non-gBRCAmut cohort. Secondary endpoints were safety and
long-term exploratory endpoints, including overall survival. GSK is in ongoing
discussions about these and other emerging OS data with health authorities
worldwide.

 

About ovarian cancer

Ovarian cancer is the eighth most common cancer in women worldwide. i  Despite
high response rates to platinum-based chemotherapy in the front-line setting,
approximately 85% of patients will experience disease recurrence. ii  Once the
disease recurs, it is rarely curable, with decreasing time intervals for each
subsequent recurrence.

 

About Zejula (niraparib)

Zejula is an oral, once-daily PARP inhibitor currently being evaluated in
multiple pivotal trials. GSK is building a robust clinical development
programme by assessing activity across multiple tumour types and evaluating
several potential combinations of Zejula with other therapeutics. The ongoing
development programme includes several combination studies, including the
FIRST phase III trial assessing niraparib in combination with dostarlimab, a
programmed death receptor-1 (PD-1)-blocking antibody, as a potential treatment
for first-line ovarian cancer maintenance and the phase III ZEAL trial
assessing niraparib in combination with standard of care for the maintenance
treatment of first line advanced non-small cell lung cancer. GSK also is
evaluating niraparib in HER2-negative BRCA-mutated or triple-negative breast
cancer.

 

Please see accompanying US Prescribing Information
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Zejula_Capsules/pdf/ZEJULA-CAPSULES-PI-PIL.PDF)
.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com/company
(https://www.gsk.com/en-gb/company/)

 

 

 

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the Company's Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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 i  Worldwide Cancer Data. World Cancer Research Fund.
https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data.
Updated January 10, 2022. Accessed July 2022.

 

 ii  Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role
of secondary surgery in recurrent ovarian cancer [published online August 5,
2012]. Int J Surg Oncol. 2012. doi:10.1155/2012/613980. Accessed September
2022.

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