Dostarlimab and niraparib in primary advanced ovarian cancer
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F25%3A10507331" target="_blank" >RIV/00064165:_____/25:10507331 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/25:10507331
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=DqYKHvr7Dz" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=DqYKHvr7Dz</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.annonc.2025.05.009" target="_blank" >10.1016/j.annonc.2025.05.009</a>
Alternative languages
Result language
angličtina
Original language name
Dostarlimab and niraparib in primary advanced ovarian cancer
Original language description
Background: The combination of immunotherapies and poly (ADP-ribose) polymerase inhibitors (PARPis) has been hypothesized to improve outcomes in advanced ovarian cancer (aOC). The FIRST/ENGOT-OV44 trial evaluated adding dostarlimab to first-line platinum-based chemotherapy (PBCT) and niraparib maintenance +- bevacizumab in patients with aOC. Patients and methods: In this randomized, double-blind, phase III trial, patients with newly diagnosed stage III-IV epithelial OC were randomized (1:2) to arm 2 (PBCT-placebo with niraparib maintenance) or arm 3 (PBCT-dostarlimab with dostarlimab-niraparib maintenance); arm 1 (PBCT-placebo with placebo maintenance) enrollment terminated following PARPi approvals. Efficacy was assessed in arms 2 and 3 (intention-to-treat population). The primary endpoint was investigator-assessed progression-free survival (PFS) as per RECIST v1.1. The key secondary endpoint was overall survival (OS). Safety was assessed in patients who received one or more doses of study treatment (arms 1-3; analyzed as per treatment received). Results: From 14 November 2018 to 5 January 2021, 1138 patients were randomized to arms 2 (n = 385) and 3 (n = 753) and included in efficacy analyses. Median follow-up was 53.1 (interquartile range 47.5-59.7) months. There was a statistically significant difference in PFS in arm 3 versus arm 2 (median 20.6 versus 19.2 months; hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.73-0.99, P = 0.0351). OS had reached 57% maturity and was not statistically significant (median 44.4 versus 45.4 months; HR 1.01, 95% CI 0.86-1.19, P = 0.9060). Toxicities observed were consistent with known safety profiles of the agents used in the study. Conclusions: In the first-line treatment of patients with aOC, the addition of dostarlimab to PBCT and niraparib maintenance was associated with a statistically significant, but clinically modest, PFS improvement, with no difference in OS.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30214 - Obstetrics and gynaecology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Annals of Oncology
ISSN
0923-7534
e-ISSN
1569-8041
Volume of the periodical
36
Issue of the periodical within the volume
12
Country of publishing house
GB - UNITED KINGDOM
Number of pages
11
Pages from-to
1503-1513
UT code for WoS article
001727156600001
EID of the result in the Scopus database
2-s2.0-105007061853