Plain Language Summary
What is this summary about?
This PLSP provides a short summary of an original scientific article that presented results from the PRIMA study after 3.5 years of follow-up time. The original article was published in the European Journal of Cancer in 2023.
The PRIMA study included adult patients with newly diagnosed advanced high-risk ovarian cancer whose tumors shrunk or became undetectable after treatment with chemotherapy with or without surgery. The PRIMA study evaluated how well the drug niraparib, also known as Zejula, worked at delaying or preventing ovarian cancer from coming back (recurring) or getting worse (progressing) compared with placebo (a substance with no effects that a doctor gives to a patient instead of a drug). The first results from the PRIMA study were published in 2019, when patients had participated in the PRIMA study for about 1.2 years.
The article this PLSP is based on reports longer-term data from the PRIMA study, when patients had participated in the PRIMA study for about 3.5 years. Patients were monitored (or followed) for a longer time to understand how well niraparib continued to work and to evaluate whether the safety of niraparib changed with additional time being monitored.
What were the results?
Patients who took niraparib had more time before their cancer came back or got worse than patients who took placebo. In terms of safety, no new types of side effects with niraparib treatment were observed with additional time being monitored as part of the PRIMA study.
What do the results mean?
These results support that niraparib remains an important treatment option to help delay the cancer from coming back or getting worse in patients with newly diagnosed advanced ovarian cancer that responded to initial treatment.
Clinical Trial Registration: NCT02655016 (PRIMA study) (ClinicalTrials.gov)
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Financial disclosure
The PRIMA study (NCT02655016) was funded by GSK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Medical writing and editorial assistance for this PLSP, funded by GSK and coordinated by Hasan Jamal and Prudence L Roaf of GSK, were provided by Betsy C Taylor and Jennifer Robertson of Ashfield MedComms, an Inizio company.
Acknowledgments
The authors would like to thank the patients, their families, the clinical investigators, and the site personnel who participated in the PRIMA study.
Competing interests disclosure
A González-Martín reports manuscript funding from GSK; research/grant funding from Roche and Tesaro/GSK; advisory/consulting fees from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, Hedera Dx, ImmunoGen, Illumina, MacroGenics, Mersana, MSD, Novartis, Novocure, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Seagen, Sotio, Sutro, Takeda, and Tubulis; speaker bureau fees from AstraZeneca, Clovis Oncology, GSK, PharmaMar, and Roche; and support for attending meetings from AstraZeneca, GSK, PharmaMar, and Roche. B Pothuri reports institutional grant support from AstraZeneca, Celsion, Clovis Oncology, Eisai, Genentech/Roche, GSK, I-Mab, Immunogen, Incyte, Karyopharm, Merck, Mersana, Onconova, Seagen, Sutro Biopharma, and Toray; consulting fees from AstraZeneca, GOG Foundation, GSK, Merck, and Seagen; support for attending meetings from GOG Partners; advisory board fees from Arquer Diagnostics, Atossa, Clovis Oncology, Deciphera, Eisai, Elevar Therapeutics, GOG Foundation, I-Mab, Immunogen, Lily, Merck, Mersana, Natera, Onconova, Regeneron, Sutro Biopharma, Tesaro/GSK, Toray, and VBL Therapeutics. I Vergote reports institutional payments for corporate-sponsored research from Amgen and Roche and contracted research from Genmab and Oncoinvent AS; institutional consulting fee payments from Amgen (Europe) GmbH, AstraZeneca, Carrick Therapeutics, Clovis Oncology, Deciphera Pharmaceuticals, Elevar Therapeutics, F. Hoffmann–La Roche, Genmab, GSK, Immunogen, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Oncoinvent AS, Octimet Oncology, Sotio, Verastem Oncology, and Zentalis; consulting fees from Deciphera Pharmaceuticals, Jazz Pharmaceuticals, and Oncoinvent AS; honoraria payments from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, F. Hoffmann–La Roche, Genmab, GSK, Immunogen, Jazz Pharmaceuticals, Karyopharm, MSD, Novartis, Novocure, Oncoinvent AS, Seagen, and Sotio; institutional travel support from Amgen, AstraZeneca, MSD, Roche, and Tesaro; advisory board fees from Agenus, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals (2021), Eisai, F. Hoffmann–La Roche, Genmab, GSK, Immunogen, MSD, Novocure, Novartis, Seagen (2021), and Sotio. W Graybill reports consulting and speaker fees from GSK. D Lorusso reports consulting fees from Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, MSD, PharmaMar, and Seagen; honoraria from AstraZeneca, Clovis Oncology, GSK, MSD, and PharmaMar; payment for expert testimony from Clovis Oncology; support for attending meetings and/or travel from AstraZeneca, Clovis Oncology, GSK, PharmaMar, and Roche; personal advisory board fees from AstraZeneca, Clovis Oncology, Corcept, Genmab, GSK, Immunogen, Merck Serono, MSD, Oncoinvent, PharmaMar, Seagen, and Sutro; member of board of directors at GCIG (no compensation); medical writing support from Clovis Oncology, GSK, MSD, and PharmaMar; and institutional funding for work in clinical trials from AstraZeneca, Clovis Oncology, Genmab, GSK, Immunogen, Incyte, MSD, Novartis, PharmaMar, Roche, and Seagen. CC McCormick reports advisory role fees from AstraZeneca, Clovis, GSK, ImmunoGen, and Merck. G Freyer reports honoraria and consulting fees from GSK. F Backes reports personal fees from Agenus, AstraZeneca, CEC Oncology, Clovis, Eisai, GSK, Immunogen, Merck, and Myriad and grants from BeiGene, Clovis, Eisai, Immunogen, Merck, and Natera. F Heitz reports honoraria from AstraZeneca, GSK, Roche, and Tesaro; consulting fees from AstraZeneca, GSK, Roche, and Tesaro. A Redondo reports institutional grants from Eisai, PharmaMar, and Roche; honoraria fees from AstraZeneca, Clovis, Eisai, GSK, MSD, and PharmaMar; advisory board roles at AstraZeneca, Clovis, Eisai, GSK, MSD, and PharmaMar; and travel support from AstraZeneca, GSK, and PharmaMar. RG Moore reports grants from Angle Plc and Fujirebio Diagnostics and personal consulting fees from Fujirebio Diagnostics. C Vulsteke reports medical writing support to GSK; consulting fees from Atheneum Partners, Bristol Myers Squibb, GSK, Janssen-Cilag, Leo Pharma, MSD, and Roche; advisory board fees from AstraZeneca, Bayer, GSK, Janssen-Cilag, Leo Pharma, and MSD; and travel support from Pfizer and Roche. RE O'Cearbhaill reports institutional research support from NIH/NCI Cancer Center Support Grant (P30 CA008748); participating in advisory boards with Bayer, Carina Biotech, Fresenius Kabi, Immunogen, Regeneron, R-Pharm, Seattle Genetics, and Tesaro/GSK; personal fees from GOG Foundation; travel fees from Hitech Health; service as a noncompensated steering committee member for the DUO-O (olaparib) and PRIMA and Moonstone (niraparib) studies; institutional research support grants from AstraZeneca/Merck, Atara Biotherapeutics/Bayer, Genentech, Genmab, GSK, Gynecologic Oncology Group Foundation, Juno Therapeutics, Kite/Gilead, Ludwig Institute for Cancer Research, Regeneron, Sellas Life Sciences, Stemcentrx, Syndax, TapImmune, and TCR2 Therapeutics. IA Malinowska and L Shtessel are employees of GSK. N Compton is a former employee of GSK and currently receiving consulting fees from GSK. MR Mirza reports consulting fees from AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, and Zailab; speakers' bureau fees from AstraZeneca and GSK; research funding (to institution) from Apexigen, AstraZeneca, Deciphera (trial chair), GSK, and Ultimovacs; and personal financial interest in Karyopharm (stocks/shares, member of board of directors). BJ Monk reports consulting fees from Agenus, Akeso Biopharma, Amgen, Aravive, Bayer, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, ImmunoGen, Iovance, Karyopharm, MacroGenics, Mersana, Myriad, Novartis, Novocure, Pfizer, Puma, Regeneron, Sorrento, US Oncology Research, and VBL; and speakers' bureau honoraria from AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GSK. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.