Abstract
What is this summary about?
This document provides a summary of results from the article that evaluated the safety and efficacy of the fixed and individualized starting doses of niraparib in the PRIMA study. The original article was published in the journal Cancer in March 2023.
The PRIMA study included adult patients with newly diagnosed advanced ovarian cancer who had finished treatment with chemotherapy and surgery. Once patients entered the study, they were treated with an oral (by mouth) medication called niraparib or placebo (substance with no effects that a doctor gives to a patient instead of a drug). The amount of drug (dose) prescribed for patients to take at the start of treatment was determined by the study plan (a document that describes in detail how the study will be performed). Some patients were treated with a fixed starting dose (300 milligrams [mg] once daily), while others were treated with an individualized dose (200 or 300 mg once daily) based on how much they weighed and the results of their blood test. The individualized dose was tested to see if it improved patient safety without changing its efficacy (how well the drug worked).
What were the results?
The individualized starting dose of niraparib improved patient safety, with a lower proportion of patients experiencing side effects than the fixed starting dose. The individualized starting dose of niraparib also delayed the cancer from coming back (recurring) or getting worse (progressing) compared with placebo. The delay in the cancer coming back or getting worse with niraparib treatment was generally similar in patients who received the individualized starting dose and those who received the fixed starting dose of niraparib.
What do the results mean?
The results support the use of the individualized starting dose of niraparib, which uses a patient’s body weight and blood test results to determine how much drug they should receive at the start of treatment. The study found that the individualized starting dose improved safety compared with the fixed starting dose while still delaying the cancer from coming back or getting worse.
Clinical Trial Registration: NCT02655016 (PRIMA study) (ClinicalTrials.gov)
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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.
Competing interests disclosure
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). 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; speakers’ bureau fees from AstraZeneca, Clovis Oncology, GSK, PharmaMar and Roche; and support for attending meetings from AstraZeneca, GSK, PharmaMar and Roche. WS Graybill reports consulting and speaker fees from GSK. DM O’Malley reports personal fees from Ambry, Arquer Diagnostics, Celsion Corp, Corcept Therapeutics, Elevar, INXMED, Myriad Genetics, Novartis, Roche Diagnostics MSA, Rubis, Sorrento, Takeda, Tarveda and Toray; personal fees and funding for clinical research from AbbVie, Agenus, Amgen, AstraZeneca, Clovis, Eisai, Genentech/Roche, GOG Foundation, Immunogen, Iovance, Janssen/J&J, Merck, Mersana, Novocure, Regeneron, SDP Oncology (BBI), Seagen and Tesaro/GSK; and funding for clinical research from Ajinomoto, Array Biopharma, Bristol Myers Squibb, Cerulean Pharma, EMD Serono, Ergomed, Genmab, INC Research, inVentiv Health Clinical, Ludwig Cancer Research, New Mexico Cancer Care Alliance, PRA International, Serono, Stemcentrx, Tracon Pharmaceuticals, VentiRx and Yale University. L Gaba reports consulting fees, advisory board and honoraria fees from AstraZeneca, Clovis Oncology, GSK, MSD and PharmaMar, and support for attending meetings from AstraZeneca, Clovis Oncology, GSK and MSD. EM Guerra reports consulting fees from AstraZeneca, Clovis Oncology, GSK, Merck, PharmaMar, Roche and Tesaro; honoraria from AstraZeneca, Clovis Oncology, GSK/Tesaro and Merck; payment for expert testimony from AstraZeneca, Clovis Oncology, GSK, Merck and Tesaro; travel support from GSK, Roche and Tesaro; advisory board participation for AstraZeneca, GSK, Merck and Tesaro. J-F Baurain consulting fees from AstraZeneca, Bristol Myers Squibb, GSK, Immunocore, Merck, MSD, Novartis, Pfizer, Pierre-Fabre, Regeneron, Sanofi and Sun Pharma. SA Ghamande reports institutional fees from the Georgia Cancer Center for the trial and consulting and speakers’ bureau fees from Eisai and GSK. H Denys reports an institutional research grant from Gilead; consulting fees from Gilead and GSK; honoraria from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Leo Pharma, MSD and Roche; travel support from AstraZeneca, Gilead, GSK, MSD, Pfizer, PharmaMar, Roche and Teva; and participation on advisory boards for AstraZeneca, Eli Lilly, Gilead, GSK, Menarini, MSD and Pfizer. E Prendergast reports consulting or advisory role at AstraZeneca and Merck. P Follana reports payment for expert testimony from AstraZeneca, Clovis, Daiichi, GSK and Novartis and support for attending meetings from AstraZeneca, Daiichi, GSK and Novartis. PM Calvert received travel support for congress attendance from MSD. J Korach serves in a leadership role for ISGO. Y Li is a former employee of GSK, reports GSK stock ownership and is currently an employee at Adagio Therapeutics. IA Malinowska is a current employee of GSK. D Gupta is a former employee of GSK and is a current employee of Mersana Therapeutics. 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. OWS Yap, PG Rose, C Pisano and K Baumann have nothing to disclose. 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.
Writing disclosure
Writing and editorial support, funded by GSK (Waltham, MA, USA) and coordinated by Hasan Jamal and Prudence L Roaf of GSK, was provided by Betsy C Taylor and Jennifer Robertson of Ashfield MedComms, an Inizio company.
Open access
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
Acknowledgments
The authors would like to thank the patients, their families, the clinical investigators and site personnel who participated in the PRIMA study.