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1. Patterns of initial ovarian cancer recurrence on niraparib maintenance monotherapy in patients with no baseline evidence of disease after first-line chemotherapy: An ad hoc subgroup analysis of PRIMA/ENGOT-OV26/GOG-3012

Author

Kamrava, Mitchell R., Gonzalez-Martin, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Mirza, Mansoor R., McCormick, Colleen, Lorusso, Domenica, Freyer, Gilles, O'Malley, David M., York, Whitney, Malinowska, Izabela A., and Monk, Bradley J.

Published
2024
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2. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Valabrega, Giorgio, Pothuri, Bhavana, Oaknin, Ana, Graybill, Whitney S., Sánchez, Ana Beatriz, McCormick, Colleen, Baurain, Jean-François, Tinker, Anna V., Denys, Hannelore, O’Cearbhaill, Roisin E., Hietanen, Sakari, Moore, Richard G., Knudsen, Anja Ør, de La Motte Rouge, Thibault, Heitz, Florian, Levy, Tally, York, Whitney, Gupta, Divya, Monk, Bradley J., and González-Martín, Antonio

Published
2024
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3. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

Graybill, Whitney S, Pardo Búrdalo, Beatriz, O’Malley, David M, Vergote, Ignace, Monk, Bradley J, Auranen, Annika, Copeland, Larry J, Sabbatini, Roberto, Herzog, Thomas J, Follana, Philippe, Pothuri, Bhavana, Braicu, Elena Ioana, McCormick, Colleen, Yubero, Alfonso, Moore, Richard G, Vuylsteke, Peter, Raaschou-Jensen, Nicoline, York, Whitney, Hartman, John, González-Martín, Antonio, and Stockman, Liz

Published
2024
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4. Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C., Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, O'Cearbhaill, Roisin E., Malinowska, Izabela A., Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R., and Monk, Bradley J.

Published
2023
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6. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

O'Cearbhaill, Roisin E., Pérez-Fidalgo, Jose-Alejandro, Monk, Bradley J., Tusquets, Ignacio, McCormick, Colleen, Fuentes, Jose, Moore, Richard G., Vulsteke, Christof, Shahin, Mark S., Forget, Frédéric, Bradley, William H., Hietanen, Sakari, O'Malley, David M., Dørum, Anne, Slomovitz, Brian M., Baumann, Klaus, Selle, Frédéric, Calvert, Paula M., Artioli, Grazia, Levy, Tally, Kumar, Aalok, Malinowska, Izabela A., Li, Yong, Gupta, Divya, and González-Martín, Antonio

Published
2022
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7. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer – a plain language summary.

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C, Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G, Vulsteke, Christof, O'Cearbhaill, Roisin E, Malinowska, Izabela A, Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R, and Monk, Bradley J

Abstract

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) [ABSTRACT FROM AUTHOR]

Published
2024
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8. Niraparib in Patients With Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Christensen, René DePont, Graybill, Whitney, Mirza, Mansoor R., McCormick, Colleen, Lorusso, Domenica, Hoskins, Paul, Freyer, Gilles, Baumann, Klaus, Jardon, Kris, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, OʼCearbhaill, Roisin E., Lund, Bente, Backes, Floor, Barretina-Ginesta, Pilar, Haggerty, Ashley F., Rubio-Pérez, Maria J., Shahin, Mark S., Mangili, Giorgia, Bradley, William H., Bruchim, Ilan, Sun, Kaiming, Malinowska, Izabela A., Li, Yong, Gupta, Divya, and Monk, Bradley J.

Published
2020
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9. EP263/#849 Olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: characterization of long-term/short-term treatment duration in light

Author

Liu, Ying, primary, Mathews, Cara, additional, Simpkins, Fiona, additional, Cadoo, Karen, additional, Provencher, Diane, additional, Mccormick, Colleen, additional, Einaggar, Adam, additional, Altman, Alon, additional, Gilbert, Lucy, additional, Black, Destin, additional, Kabil, Nashwa, additional, Taylor, Rosie, additional, Barnicle, Alan, additional, Munley, Jiefen, additional, and Aghajanian, Carol, additional

Published
2022
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10. EP233/#541 Patterns of initial ovarian cancer recurrence on niraparib maintenance monotherapy in patients with no baseline evidence of disease following first-line chemotherapy: PRIMA/ENGOT-ov26/GOG-3012 post-hoc subgroup analysis

Author

Kamavra, M, primary, Gonzalez-Martin, Antonio, additional, Pothuri, Bhavana, additional, Vergote, Ignace, additional, Graybill, Whitney S, additional, Mirza, Mansoor, additional, Mccormick, Colleen, additional, Lorusso, D, additional, Freyer, G, additional, O’Malley, David, additional, York, Whitney, additional, Malinowska, Izabela A, additional, and Monk, Bradley, additional

Published
2022
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11. TP001/#1553 GOG-3043 (NCT04831580): a randomized non-inferiority trial of robotic versus open radical hysterectomy for early stage cervical cancer (ROCC)

Author

Bixel, Kristin, primary, Leitao, Mario, additional, Chase, Dana, additional, Quick, Allison, additional, Lim, Peter, additional, Eskander, Ramez, additional, Gotlieb, Walter, additional, Lococo, Salvatore, additional, Martino, Martin, additional, Mccormick, Colleen, additional, Myers, Tashanna, additional, Tewari, Krishnansu, additional, Slomovitz, Brian, additional, Walker, Joan, additional, Copeland, Larry, additional, Monk, Bradley, additional, and Randall, Leslie, additional

Published
2022
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14. ROCC/GOG-3043: A randomized non-inferiority trial of robotic versus open radical hysterectomy for early-stage cervical cancer.

Author

Bixel, Kristin Leigh, primary, Leitao, Mario M., additional, Chase, Dana Meredith, additional, Quick, Allison, additional, Lim, Peter C, additional, Eskander, Ramez Nassef, additional, Gotlieb, Walter H., additional, LoCoco, Salvatore, additional, Martino, Martin A, additional, McCormick, Colleen, additional, Myers, Tashanna K. N., additional, Tewari, Krishnansu Sujata, additional, Slomovitz, Brian M., additional, Walker, Joan L., additional, Copeland, Larry J., additional, Monk, Bradley J., additional, and Randall, Leslie M., additional

Published
2022
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16. Efficacy of niraparib by timing of surgery and residual disease: a post-hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

O'Cearbhaill, Roisin, primary, Pérez-Fidalgo, Jose Alejandro, additional, Monk, Bradley, additional, Tusquets, Ignasi, additional, McCormick, Colleen, additional, Fuentes, Jose, additional, Moore, Richard, additional, Vulsteke, Christof, additional, Shahin, Mark, additional, Forget, Frédéric, additional, Bradley, William, additional, Hietanen, Sakari, additional, O'Malley, David, additional, Dørum, Anne, additional, Slomovitz, Brian, additional, Baumann, Klaus, additional, Selle, Frédéric, additional, Calvert, Paula, additional, Artioli, Grazia, additional, Levy, Tally, additional, Kumar, Aalok, additional, Malinowska, Izabela, additional, Li, Yong, additional, Gupta, Divya, additional, and González-Martín, Antonio, additional

Published
2021
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17. Olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: secondary efficacy results from the phase II LIGHT study

Author

Cadoo, Karen, primary, Simpkins, Fiona, additional, Mathews, Cara, additional, Liu, Ying, additional, Provencher, Diane, additional, McCormick, Colleen, additional, ElNaggar, Adam, additional, Kabil, Nashwa, additional, Bennett, James, additional, Yu, Hong, additional, Munley, Jiefen, additional, and Aghajanian, Carol, additional

Published
2021
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19. Olaparib treatment (Tx) in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Overall survival (OS) results from the phase II LIGHT study.

Author

Mathews, Cara Amanda, primary, Simpkins, Fiona, additional, Cadoo, Karen Anne, additional, Liu, Ying L, additional, Provencher, Diane M., additional, McCormick, Colleen, additional, ElNaggar, Adam, additional, Altman, Alon D, additional, Gilbert, Lucy, additional, Black, Destin, additional, Kabil, Nashwa, additional, Bennett, James, additional, Munley, Jiefen, additional, Yu, Judy, additional, and Aghajanian, Carol, additional

Published
2021
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20. 347 Efficacy and safety of niraparib in older patients (PTS) with advanced ovarian cancer (OC): results from the prima/ENGOT-OV26/GOG-3012 trial

Author

Dahlstrand, Hanna, primary, Pothuri, Bhavana, additional, Graybill, Whitney, additional, Rouge, Thibault de La Motte, additional, Mccormick, Colleen, additional, Heitz, Florian, additional, Baurain, Jean-Francois, additional, Yong, LI, additional, Monk, Bradley J, additional, and González-Martin, Antonio, additional

Published
2020
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22. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, primary, Pothuri, Bhavana, additional, Vergote, Ignace, additional, DePont Christensen, René, additional, Graybill, Whitney, additional, Mirza, Mansoor R., additional, McCormick, Colleen, additional, Lorusso, Domenica, additional, Hoskins, Paul, additional, Freyer, Gilles, additional, Baumann, Klaus, additional, Jardon, Kris, additional, Redondo, Andrés, additional, Moore, Richard G., additional, Vulsteke, Christof, additional, O’Cearbhaill, Roisin E., additional, Lund, Bente, additional, Backes, Floor, additional, Barretina-Ginesta, Pilar, additional, Haggerty, Ashley F., additional, Rubio-Pérez, Maria J., additional, Shahin, Mark S., additional, Mangili, Giorgia, additional, Bradley, William H., additional, Bruchim, Ilan, additional, Sun, Kaiming, additional, Malinowska, Izabela A., additional, Li, Yong, additional, Gupta, Divya, additional, and Monk, Bradley J., additional

Published
2019
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23. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Author

Mirza, Mansoor R, Monk, Bradley J, Herrstedt, Jørn, Oza, Amit M, Mahner, Sven, Redondo, Andrés, Fabbro, Michel, Ledermann, Jonathan A, Lorusso, Domenica, Vergote, Ignace, Ben-Baruch, Noa E, Marth, Christian, Madry, Radoslaw, Christensen, René D, Berek, Jonathan S, Dørum, Anne, Tinker, Anna V, du Bois, Andreas, González-Martín, Antonio, Follana, Philippe, Benigno, Benedict, Rosenberg, Per, Gilbert, Lucy, Rimel, Bobbie J, Buscema, Joseph, Balser, John P, Agarwal, Shefali, Matulonis, Ursula A, Lund, Bente, Malander, Susanne, Woie, Kathrine, Hellman, Kristina, Nøttrup, Trine Juhler, Havsteen, Hanne, Sehouli, Jalid, Harter, Philipp, Canzler, Ulrich, Lück, Hans-Joachim, Wölber, Linn, Marmé, Frederik, Meier, Werner, Heubner, Martin, Hilpert, Felix, Emons, Günter, Burges, Alexander, Bover Barcelo, Isabel Maria, Gil Martín, Marta, Palacio Vázquez, Isabel, Casado Herráez, Antonio, Maria del Campo, José, Lesoin, Anne, Berton-Rigaud, Dominique, N'Guyen, Thierry, Hardy-Bessard, Anne-Claire, Banerjee, Susana, Lord, Rosemary, Waters, Justin, Montes, Ana, Chan, Stephen, Williams, Sarah J, Barlow, Claire, Mullard, Anna, Colombo, Nicoletta, Scambia, Giovanni, Tognon, Germana, Scollo, Paolo, Kridelka, Frédéric, Leroy, Chantal, Debruyne, Philip, Huizing, Manon, Rosengarten, Ora, Levy, Talia, Frommer, Ronnie Shapira, Fishman, Ami, Edelman, David, Safra, Tamar, Amit, Amnon, Pikiel, Joanna, Suzin, Jacek, Mackowiak-Matejczyk, Beata, Reinthaller, Alexander, Petru, Edgar, Csoszi, Tibor, Bessette, Paul, Provencher, Diane, Lau, Susie, Ellard, Susan, Ghatage, Prafull, Moore, Kathleen, Wenham, Robert, Pineda, Mario, Azodi, Masoud, Mantia-Smaldone, Gina, Cloven, Noelle, Bailey, Cheryl, Lee, Christine, Secord, Angeles, Patel, Manish, Method, Michael, Callahan, Michael, Veena, John, Chan, John, Zarwan, Corrine, DiSilvestro, Paul, Teneriello, Michael, Gupta, Divya, Geller, Melissa, Burris, Howard, Slomovitz, Brian, Hendrickson, Andrea Wahner, McCormick, Colleen, Hanjani, Parviz, Blank, Stephanie, Haluska, Paul, Matei, Daniela, Vasilev, Stephen, Neidhart, Jeffrey, Boente, Matthew, Tchabo, Nana, Miller, David, and Targeted Gynaecologic Oncology (TARGON)

Subjects
0301 basic medicine, Oncology, Medizin, Genes, BRCA1, Platinum Compounds, POLY(ADP-RIBOSE) POLYMERASE, Kaplan-Meier Estimate, 030226 pharmacology & pharmacy, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Maintenance therapy, Bone Marrow, Medicine, Merck Sharp & Dohme, Homologous Recombination, Indazoles/adverse effects, Ovarian Neoplasms, Aged, 80 and over, Platinum compounds, OLAPARIB, Ovarian Neoplasms/drug therapy, Obstetrics and Gynecology, Bone Marrow/drug effects, General Medicine, Middle Aged, SOLID TUMORS, BRCA MUTATION CARRIERS, 030220 oncology & carcinogenesis, TRIAL, Female, Platinum sensitive, Adult, Piperidines/adverse effects, medicine.medical_specialty, Indazoles, Adolescent, Antineoplastic Agents, Disease-Free Survival, Olaparib, Maintenance Chemotherapy, Young Adult, 03 medical and health sciences, Platinum Compounds/therapeutic use, Double-Blind Method, Internal medicine, Humans, Rucaparib, Germ-Line Mutation, Aged, Neoplasm Staging, Cancer och onkologi, business.industry, Antineoplastic Agents/adverse effects, NEGATIVE BREAST-CANCER, 030104 developmental biology, chemistry, Recurrent Ovarian Cancer, Cancer and Oncology, Johnson Johnson, business
Abstract

BACKGROUND Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. METHODS In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2: 1 ratio to receive niraparib (300 mg) or placebo once daily. The primary end point was progression-free survival. RESULTS Of 553 enrolled patients, 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo). Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59) and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (hazard ratio, 0.45; 95% CI, 0.34 to 0.61; P amp;lt; 0.001 for all three comparisons). The most common grade 3 or 4 adverse events that were reported in the niraparib group were thrombocytopenia (in 33.8%), anemia (in 25.3%), and neutropenia (in 19.6%), which were managed with dose modifications. CONCLUSIONS Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer among those receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity. (Funded by Tesaro; ClinicalTrials.gov number, NCT01847274.) Funding Agencies|Tesaro; Amgen; Genentech; Roche; AstraZeneca; Myriad Genetics; Merck; Gradalis; Cerulean; Vermillion; ImmunoGen; Pfizer; Bayer; Nu-Cana BioMed; INSYS Therapeutics; GlaxoSmithKline; Verastem; Mateon Therapeutics; Pharmaceutical Product Development; Clovis Oncology; Janssen/Johnson Johnson; Eli Lilly; Merck Sharp Dohme

Published
2016
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24. A phase Ib/II study of cancer stemness inhibitor napabucasin (BB608) combined with weekly paclitaxel in platinum-resistant ovarian cancer.

Author

Garcia, Agustin A., primary, Hays, John L., additional, Cote, Gregory Michael, additional, Becerra, Carlos, additional, Langleben, Adrian, additional, Lau, Susie K, additional, Roman, Lynda D., additional, McCormick, Colleen Catherine, additional, Richards, Donald A., additional, Braiteh, Fadi S., additional, Yimer, Habte Aragaw, additional, Richey, Stephen Lane, additional, Edenfield, William Jeffery, additional, Kossler, Kimiko, additional, Hume, Stephanie, additional, Li, Youzhi, additional, Hitron, Matthew, additional, and Li, Chiang, additional

Published
2016
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26. Predictors of long-term progression-free survival (PFS) in niraparib-treated patients (pts) from the PRIMA/ENGOT-OV26/GOG-3012 study.

Author

Graybill, Whitney, Pardo, Beatriz, O'Malley, David M., Vergote, Ignace, Monk, Bradley J., Auranen, Annika, Copeland, Larry J., Sabbitini, Roberto, Herzog, Thomas J, Follana, Philippe, Pothuri, Bhavana, Braicu, Elena Ioana, McCormick, Colleen, Yubero-Esteban, Alfonso, Moore, Richard G., Vuylsteke, Peter, Raashouu-Jensen, Nicoline, York, Whitney, Hartman, John, and Gonzalez Martin, Antonio

Published
2023
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30. Examining health-related quality of life outcomes among older patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in context with efficacy and safety findings: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial.

Author

Pothuri, Bhavana, Valabrega, Giorgio, Oaknin, Ana, Graybill, Whitney, Sánchez, Ana Beatriz, McCormick, Colleen, Baurain, Jean-François, Tinker, Anna, Denys, Hannelore, O'Cearbhaill, Roisin, Hietanen, Sakari, Moore, Richard, Knudsen, Anja, de La Motte Rouge, Thibault, Heitz, Florian, Levy, Tally, York, Whitney, Malinowska, Izabela, Monk, Bradley, and González-Martín, Antonio

Subjects
*CANCER patients, *QUALITY of life, *OLDER patients
Published
2024
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31. Olaparib as treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency: Phase 2 LIGHT study final overall survival analysis.

Author

Liu YL, Mathews CA, Simpkins F, Cadoo KA, Provencher D, McCormick CC, ElNaggar AC, Altman AD, Gilbert L, Black D, Kabil N, Taylor RN, Barnicle A, Munley JY, and Aghajanian C

Subjects
Humans, Female, Middle Aged, Aged, Adult, BRCA1 Protein genetics, BRCA2 Protein genetics, Homologous Recombination, Mutation, Poly(ADP-ribose) Polymerase Inhibitors therapeutic use, Aged, 80 and over, Prospective Studies, Survival Analysis, Phthalazines therapeutic use, Piperazines therapeutic use, Ovarian Neoplasms drug therapy, Ovarian Neoplasms genetics, Ovarian Neoplasms mortality, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local genetics
Abstract

Background: LIGHT (oLaparib In HRD-Grouped Tumor types; NCT02983799) prospectively evaluated olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer (PSROC) assigned to cohorts by known BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive non-BRCAm, and HRD-negative. At the primary analysis, olaparib treatment demonstrated activity across all cohorts, with greatest efficacy in terms of objective response rate and progression-free survival observed in the g/sBRCAm cohorts. The authors report final overall survival (OS)., Methods: In this phase 2, open-label, noncomparative study, patients with PSROC and one or more prior line of platinum-based chemotherapy were assigned to cohorts by BRCAm and HRD status. OS was a secondary end point. Tumors were analyzed using Myriad BRACAnalysis CDx and MyChoice CDx assays; HRD-positive tumors were defined using a genomic instability score of ≥42., Results: Of 272 enrolled patients, 271 received olaparib and 270 met the inclusion criteria for the efficacy analysis. At data cutoff, 18-month OS rates in the gBRCAm, sBRCAm, HRD-positive non-BRCAm, and HRD-negative cohorts were 86.4%, 88.0%, 78.6%, and 59.6%, respectively. No new safety signals were observed. In a post hoc analysis, patients on treatment for >18 months were most frequently present in g/sBRCAm cohorts (31.0%)., Conclusions: Olaparib treatment continued to demonstrate benefit across all cohorts. Consistent with the primary analysis, the highest OS rates were observed in the BRCAm cohorts, regardless of g/sBRCAm. In patients without a BRCAm, a higher OS rate was observed in the HRD-positive non-BRCAm than the HRD-negative cohorts. These results highlight the importance of biomarker testing in this treatment setting., (© 2025 The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Published
2025
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