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IntroductionWe evaluated real-world outcomes in patients with advanced ovarian cancer (AOC) based on their cumulative risk profile and maintenance therapy (MT) status following first-line (1L) treatment.MethodsThis retrospective observational study of a nationwide electronic health record-derived de-identified database included adult patients diagnosed with stage III/IV OC from January 1, 2011 to February 28, 2021, who received 1L therapy and had ≥ 12 weeks of follow-up after the index date (end of 1L therapy). Patients were grouped according to whether they received MT or active surveillance (AS) following 1L treatment and by the cumulative number of risk factors (RF) present (stage IV disease; no surgery/treated with neoadjuvant therapy and interval debulking surgery; had postoperative visible residual disease; and had BRCA wild-type disease/unknown BRCA status). Time to next treatment (TTNT) and overall survival (OS) were assessed with a cloning and inverse probability of censoring (IPC)-weighted Kaplan-Meier method.ResultsAmong 1920 patients, 22.2% received MT and 77.8% received AS. Median IPC-weighted TTNT and OS were 13.3 months (95% CI 11.7-15.8) and 39.1 months (95% CI 32.5-48.6) in the MT cohort, respectively, and 8.6 months (95% CI 8.0-9.5) and 38.4 months (95% CI 36.4-41.0) in the AS cohort, respectively. Almost all patients had ≥ 1 RF (MT 95.3%; AS 96.7%). Median IPC-weighted TTNT was shorter among patients with more RF in both cohorts (MT: 1 RF, 19.3 months, 95% CI 13.5-37.8; 2 RF, 17.2 months, 95% CI 12.8-20.2; 3 RF, 11.0 months, 95% CI 8.2-13.8; 4 RF, 7.0 months, 95% CI 6.2-8.8; AS: 1 RF, 17.7 months, 95% CI 13.5-22.3; 2 RF, 10.2 months, 95% CI 9.1-11.5; 3 RF, 6.5 months, 95% CI 5.8-7.4; 4 RF, 4.1 months, 95% CI 3.5-4.5).ConclusionRegardless of RF number, MT was associated with longer TTNT in real-world patients with AOC.

Background: The PRIMA/ENGOT‐OV26/GOG‐3012 (NCT02655016) trial was amended to prospectively evaluate the safety and efficacy of an individualized starting dose (ISD) regimen of niraparib for first‐line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Methods: In the phase 3 PRIMA trial, patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first‐line platinum‐based chemotherapy (N = 733) were initially treated with a fixed starting dose (FSD) regimen of 300 mg once daily. Subsequently, the protocol was amended so newly enrolled patients received an ISD: 200 mg once daily in patients with baseline body weight < 77 kg or baseline platelet count < 150,000/µL, and 300 mg once daily in all other patients. Efficacy and safety outcomes were assessed by starting dose. Results: Overall, 475 (64.8%) patients were assigned to an FSD (niraparib, n = 317; placebo, n = 158) and 258 (35.2%) were assigned to an ISD (niraparib, n = 170; placebo, n = 88). Efficacy in patients who received FSD or ISD was similar for the overall (FSD hazard ratio [HR], 0.59 [95% CI, 0.46–0.76] vs. ISD HR, 0.69 [95% CI, 0.48–0.98]) and the homologous recombination–deficient (FSD HR, 0.44 [95% CI, 0.30–0.64] vs. ISD HR, 0.39 [95% CI, 0.22–0.72]) populations. In patients with low body weight/platelet count, rates of grades ≥3 and 4 hematologic treatment‐emergent adverse events, dose interruptions, and dose reductions were lower for those who received ISD than for those who received FSD. Conclusions: In PRIMA, similar dose intensity, similar efficacy, and improved safety were observed with the ISD compared with the FSD regimen. Results from the phase 3 PRIMA trial of niraparib first‐line maintenance therapy that prospectively evaluated fixed versus individualized dosing support the selection of a niraparib starting dose based on an individual's body weight and platelet count. In prespecified analyses, patients who received the individualized starting dose of niraparib experienced similar progression‐free survival and improved safety outcomes compared with patients who received the fixed starting dose of niraparib. [ABSTRACT FROM AUTHOR]

Aim: To review safety and efficacy outcomes in studies of first-line maintenance therapies for advanced ovarian cancer. Methods: A systematic literature review was performed (27 February 2020) to identify clinical outcomes including progression-free survival (PFS), overall survival (OS) and Grade ≥3 adverse events. Results: Overall 50 references met prespecified criteria; 18 studies evaluated 10 different agents, including PARP inhibitors. PFS was an end point in 16 trials and OS in 12 trials. PARP inhibitors reported better PFS hazard ratios (HRs: 0.59-0.68) compared with other classes; no mature OS data were identified. Safety reporting was inconsistent. Conclusion: Reported PFS HRs were better for PARP inhibitors than for other ovarian cancer maintenance therapies; overall survival data remain immature. [ABSTRACT FROM AUTHOR]

Background: The PRIMA phase 3 trial showed niraparib significantly prolongs median progression-free survival (PFS) versus placebo in patients with advanced ovarian cancer (OC) responsive to first-line platinum-based chemotherapy, including those who had tumors with homologous recombination deficiency (HRd). This analysis of PRIMA examined the qualityadjusted PFS (QA-PFS) and quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) of patients on maintenance niraparib versus placebo. Methods: Patients were randomized 2:1 to receive once-daily maintenance niraparib (n = 487) or placebo (n = 246). QA-PFS was defined as the PFS of patients adjusted for their health-related quality of life (HRQoL) prior to disease progression, measured using European Quality of Life Five-Dimension (EQ-5D) questionnaire index scores from the PRIMA trial. Q-TWiST was calculated by combining data on PFS, duration of symptomatic grade X2 adverse events (fatigue or asthenia, nausea, vomiting, abdominal pain, and abdominal bloating) prior to disease progression, and EQ-5D index scores. Analyses used data collected up to the last date of PFS assessment (May 17, 2019). Results: The restricted mean QA-PFS was significantly longer with niraparib versus placebo in the HRd (n = 373) and overall intention-to-treat (ITT; n = 733) populations (mean gains of 6.5 [95% confidence interval; CI, 3.9-8.9] and 4.1 [95% CI, 2.2-5.8] months, respectively). There were also significant improvements in restricted mean Q-TWiST for niraparib versus placebo (mean gains of 5.9 [95% CI, 3.5-8.6] and 3.5 [95% CI, 1.7-5.6] months, respectively) in the HRd and ITT populations. Conclusions: In patients with advanced OC, first-line niraparib maintenance was associated with significant gains in QA-PFS and Q-TWiST versus placebo. These findings demonstrate that niraparib maintenance treatment is associated with a PFS improvement and that treatment benefit is maintained even when HRQoL and/or toxicity data are combined with PFS in a single measure. [ABSTRACT FROM AUTHOR]

We reviewed clinical data for niraparib monotherapy in BRCA-mutated (BRCAm) epithelial ovarian cancer (OC), contextualizing results with data from other poly(ADP-ribose) polymerase inhibitors (PARPis). Niraparib reduced the likelihood of progression or death by 60% as first-line maintenance therapy and by 73-78% in recurrent disease. In heavily pretreated OC, efficacy was greater in the BRCAm versus non-BRCAm cohort. Quality-of-life (QoL) was maintained throughout treatment. Adverse events were consistent with the known niraparib safety profile. Cumulative efficacy, safety and QoL evidence demonstrate niraparib maintenance monotherapy has a positive benefit:risk ratio in BRCAm OC. Niraparib significantly improved progression-free survival as first-line maintenance therapy in all patients with OC (i.e., of any biomarker status). [ABSTRACT FROM AUTHOR]

Aim: Patient chart data from the USA during the period of January 2011 through October 2018 were used to assess risk factors for progression in advanced ovarian cancer after response to first-line platinum-based chemotherapy. Patients & methods: Patients with stage III/IV ovarian cancer who completed first-line platinum-based chemotherapy after primary or interval debulking surgery were identified from the Flatiron Health database. Cox proportional hazards modeling was used to assess associations between baseline factors and time to next treatment (TTNT) or overall survival (OS). Results: Patients at stage IV or who received interval debulking surgery had shorter TTNT and OS than patients at stage III or who received primary debulking surgery, respectively. OS was worse in patients with residual disease and in BRCA wild-type. Conclusion: Multiple factors were associated with shorter TTNT or OS in this retrospective real-world analysis. [ABSTRACT FROM AUTHOR]

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). 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. 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) [ABSTRACT FROM AUTHOR]

Abstract: Objectives: A phase II trial designed to evaluate the safety and efficacy of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine or epithelial ovarian cancers. Methods: Eligible patients with recurrent epithelial ovarian or uterine cancers were treated with weekly topotecan 3.5 mg/m2 and docetaxel 30 mg/m2 for 3 consecutive weeks. Cycles were repeated every 4 weeks for 6 cycles or until evidence of disease progression, unacceptable toxicity, or death. Response was assessed as per RECIST or Rustin''s criteria. Time to best response and overall survival were calculated using Kaplan–Meier statistical methods. Results: Twenty-seven patients registered, of which 24 were evaluable for response. The majority of patients had received 2 prior chemotherapy regimens. Of the total 86 cycles of chemotherapy that were administered, there were three grade 4 (all neutropenia) and ten grade 3 toxicities. Six of the grade 3 non-hematologic toxicities were unrelated to treatment. There were 8 dose delays and 4 dose reductions. The overall response rate was 25% (95% CI: 7.7%–42.3%, 8% CR, 17% PR), and 38% of the patients had clinical benefit (95% CI: 18.1%–56.9%; CR+PR+13% SD). The median duration of response was 8.5 months (range 3–19 months). The median overall survival was 18.5 months (range 1.8–50.7 months). Conclusion: The combination of weekly topotecan and docetaxel has clinical benefit and is well tolerated in this heavily treated patient population. Patients with platinum-resistant tumors had clinical benefit and should be considered for further study with this regimen. [Copyright &y& Elsevier]

To evaluate the impact of age on the efficacy and safety of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first-line platinum-based chemotherapy. Post hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016). Patients in the intent-to-treat population were categorized according to age at baseline (<65 years vs ≥65 years), and progression-free survival (PFS), safety, and health-related quality of life (HRQOL) were evaluated for each age subgroup (clinical cutoff date, May 17, 2019). Safety findings were also evaluated according to a fixed starting dose (FSD) or an individualized starting dose (ISD). Of 733 randomized patients, 289 (39.4%) were ≥65 years (190 niraparib, 99 placebo) at baseline. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) were similar in patients aged <65 years (13.9 vs 8.2 months; HR, 0.61 [0.47–0.81]) and ≥65 years (13.7 vs 8.1 months; HR, 0.53 [0.39–0.74]). The incidences of any-grade and grade ≥3 treatment-emergent adverse events (TEAEs) were similar across age subgroups; in the niraparib arm, TEAEs leading to dose discontinuation occurred in 7.8% of patients <65 years and 18.4% of patients ≥65 years. ISD use lowered the incidence of grade ≥3 thrombocytopenia events in niraparib-treated patients compared with the FSD (<65 years: 42.8% vs 18.0%; ≥65 years 57.0% vs 26.1%). HRQOL was comparable across age subgroups. Niraparib efficacy, safety, and HRQOL were generally comparable across age subgroups, although patients ≥65 years had a higher rate of discontinuations due to TEAEs. ISD use reduced grade ≥3 thrombocytopenia events regardless of age. [Display omitted] • Age-based analysis of the efficacy and safety of niraparib first-line maintenance therapy in the phase 3 PRIMA trial. • Niraparib first-line maintenance treatment improved median progression-free survival compared with placebo regardless of age. • The incidences of any-grade and grade ≥3 treatment emergent adverse events were generally similar across all age subgroups. • The individualized starting dose reduced grade ≥3 hematological treatment-emergent adverse events across all age subgroups • Niraparib did not negatively impact health-related quality of life (HRQOL), and HRQOL was similar regardless of age. [ABSTRACT FROM AUTHOR]

To assess patient-reported health-related quality of life (HRQoL) in patients with ovarian cancer (OC) who received niraparib as first-line maintenance therapy. PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) enrolled patients with newly diagnosed advanced OC who responded to first-line platinum-based chemotherapy. Patients were randomized (2:1) to niraparib or placebo once daily in 28-day cycles until disease progression, intolerable toxicity, or death. HRQoL was assessed as a prespecified secondary end point using patient-reported responses to the European Organisation for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30), the EORTC QLQ Ovarian Cancer Module (EORTC QLQ-OV28), the Functional Assessment of Cancer Therapy–Ovarian Symptom Index (FOSI), and EQ-5D-5L questionnaires. Assessments were collected at baseline and every 8 weeks (±7 days) for 56 weeks, beginning on cycle 1/day 1, then every 12 weeks (±7 days) thereafter while the patient received study treatment. Among trial participants (niraparib, n = 487; placebo, n = 246), PRO adherence exceeded 80% for all instruments across all cycles. Patients reported no decline over time in HRQoL measured via EORTC QLQ-C30 Global Health Status/QoL and FOSI overall scores. Scores for abdominal/gastrointestinal symptoms (EORTC QLQ-OV28) and nausea and vomiting, appetite loss, and constipation (EORTC QLQ-C30) were higher (worse symptoms) in niraparib-treated patients than placebo-treated patients; except for constipation, these differences resolved over time. Patients did not self-report any worsening from baseline of fatigue, headache, insomnia, or abdominal pain on questionnaires. Despite some early, largely transient increases in gastrointestinal symptoms, patients with OC treated with niraparib first-line maintenance therapy reported no worsening in overall HRQoL. [Display omitted] • Detailed analysis of patient-reported outcomes from the PRIMA trial of niraparib as a first-line maintenance therapy. • Compared with placebo, niraparib-treated patients self-reported worse symptoms of constipation, nausea/vomiting, and appetite loss. • Except for constipation, the increase in gastrointestinal symptoms compared with placebo resolved over time. • No worsening of fatigue, headache, insomnia, or abdominal pain over time were noted on self-reported questionnaires. • Overall quality of life was generally maintained with niraparib treatment despite patient-reported gastrointestinal symptoms. [ABSTRACT FROM AUTHOR]

To assess safety and efficacy of niraparib + bevacizumab as a first-line maintenance therapy for patients with newly diagnosed advanced ovarian cancer. This multicenter, phase II, single-arm, open-label study enrolled adult patients with stage IIIB to IV ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have an attempt at debulking surgery and have a complete response, partial response, or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was the progression-free survival (PFS) rate at 18 months. Secondary endpoints included PFS, overall survival, and safety. Among the 105 evaluable patients, the PFS rate at 18 months was 62% (95% CI 52–71%) in the overall population and 76% (95% CI 61–87) in the homologous recombination deficient (HRd), 47% (95% CI 31–64%) in the HR proficient (HRp), and 56% (95% CI 31–79%) in the HR not determined (HRnd) subgroups (December 24, 2020, cutoff). After a median follow-up time of 28.7 months (IQR, 23.9–32.5 months), median PFS was 19.6 months (95% CI 16.5–25.1) in the overall population (N = 105) and 28.3 months (95% CI 19.9–NE), 14.2 months (95% CI 8.6–16.8), and 12.1 months (95% CI 8.0–NE) in the HRd, HRp, and HRnd subgroups, respectively (June 16, 2021, cutoff). The most common any-grade treatment-related adverse events (related to niraparib and/or bevacizumab) were thrombocytopenia (74/105), fatigue (60/105), and anemia (55/105; December 24, 2020, cutoff). Niraparib + bevacizumab first-line maintenance therapy displayed promising PFS results. Safety was consistent with the known safety profiles of niraparib and bevacizumab as monotherapy. [Display omitted] • OVARIO enrolled patients with primary advanced-stage ovarian cancer, including high-risk cases. • In the overall population, 62% of patients were progression-free at the 18-month primary endpoint. • After a median follow-up of 28.7 months, median PFS was 19.6 months (overall), 28.3 months (HRd), and 14.2 months (HRp). • The most common any-grade adverse events related to niraparib and/or bevacizumab were thrombocytopenia, fatigue, and anemia. [ABSTRACT FROM AUTHOR]

Ovarian cancers diagnosed between 2000 and 2013 were examined and cases with and without endometriosis compared. Among 139 epithelial ovarian, there were 49 (35%) with endometriosis and 90 (65%) without endometriosis. Endometriosis associated ovarian cancers were more likely to be confined to the pelvis (54% vs. 9%,p< 0.0001) and lower grade (51% vs. 29%,p= 0.014). Younger age and earlier stage independently predicted the presence of endometriosis (p= 0.0011 andp< 0.0001, respectively). Ovarian cancer patients with endometriosis had improved PFS and OS [(HR = 0.20; 95% CI, 0.09–0.43), (HR = 0.18; 95% CI, 0.04–0.81)], compared to patients without endometriosis; however, endometriosis had no independent prognostic significance. [ABSTRACT FROM PUBLISHER]

In the ENGOT-OV16/NOVA study, maintenance therapy with niraparib significantly prolonged progression-free survival (PFS) in patients (pts) with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of germline BRCA mutation (g BRCA m) or homologous recombination deficiency (HRd) biomarker status. This analysis updates long-term safety and available data on secondary efficacy outcomes. In this randomized, double-blind, placebo-controlled, phase III trial, pts with PSROC were enrolled into 1 of 2 independent cohorts by g BRCA m status (g BRCA m or non-g BRCA m). Stratification factors were PFS after the penultimate platinum therapy (6 to <12 months vs ≥12 months), best response to the last platinum-based therapy (complete or partial), and prior bevacizumab (Y/N). Pts were randomized 2:1 to niraparib 300 mg QD or placebo. The primary endpoint was PFS as assessed by blinded independent central review. Progression-free survival 2 (PFS2) and overall survival (OS) were exploratory secondary endpoints. A total of 553 pts were randomized in the NOVA study. Median follow-up was 66 months at the time of the current analysis. Hematologic treatment-emergent adverse effects (TEAEs) primarily occurred in the first year of niraparib treatment: incidence of grade ≥3 thrombocytopenia decreased from 33.8% to 2.8%, anemia decreased from 25.6% to 0.7%, and neutropenia decreased from 19.3% to 2.1% from year 1 to year 2–3, respectively. A total of 13 (3.5%; 9 g BRCA m, 4 non-g BRCA m) pts who received niraparib developed MDS/AML vs 3 (1.7%) placebo pts. Survival status could not be obtained for ~15% of pts. Data on post-progression therapy, including PARP inhibitors, were not available for 25% of the study pts. Based on data cut-off on October 2020, 127 and 238 deaths occurred in the g BRCA m and non-g BRCA m cohorts, respectively. For pts with available data, placebo pts received subsequent PARP inhibitor therapy (crossover) after disease progression: 46% (30/65) in the g BRCA m cohort and 13% (15/116) in the non-g BRCA m cohort. Hazard ratios for PFS2 were 0.67 (95% CI: 0.48, 0.95) in the g BRCA m cohort and 0.81 (95% CI: 0.62, 1.05) in the non-g BRCA m cohort. Restricted mean survival time analyses for OS up to 72 months were 43.2 months in placebo vs 45.9 months in niraparib (Δ of 2.7m, 95% CI: -4.1, 9.5) in the g BRCA m cohort and 39.1 months in placebo vs 38.5 months in niraparib (Δ of -0.6m, 95% CI: -6.0, 4.7) in the non-g BRCA m cohort. These final data support the safe long-term use of niraparib for maintenance treatment in pts with PSROC. PFS2 analysis indicates that the benefit of niraparib maintenance therapy extends beyond first progression. No difference in survival was observed. The NOVA study was not powered for OS, and analysis is confounded by a high rate of crossover and missing data thus limiting its interpretation. GlaxoSmithKline. NCT01847274. [ABSTRACT FROM AUTHOR]

Preclinical evidence suggests that PARP inhibition (PARPi), anti-PD-1 therapy, and anti-angiogenic therapies have interactions that may support synergistic antitumor activity in pts with PROC. This phase 2 study evaluated activity of combination therapy with the PARPi niraparib, the PD-1 inhibitor dostarlimab, and bev in pts with PROC. Eligible pts had high-grade, platinum-resistant (progressed ≤6 mo after completion of ≥4 cycles of platinum-based chemo), recurrent epithelial ovarian, fallopian tube, primary peritoneal cancer, or recurrent carcinosarcoma of the ovary (high-grade mixed histology permitted). Pts had 1–2 prior lines of anticancer therapy for OC, and no prior therapy with an anti-PD-1/-L1 or PARPi. Pts received a regimen of 500 mg dostarlimab Q3W x 4, then 1000 mg Q6W + 15 mg/kg bev Q3W + niraparib 300 mg or 200 mg (for weight <77 kg or platelet count <150,000/µL at screening) QD until discontinuation. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Secondary objectives were progression-free survival (PFS), safety, and disease control rate (DCR). A posthoc analysis by biomarker (BRCA mutation [ BRCA m] status, homologous recombination repair mutation [HRRm], and combined positive score [CPS; a measure of intratumoral and immune infiltrate PD-L1 expression], prior lines of therapy, and prior bev use) was performed. A total of 41 pts were enrolled and dosed. Median age was 66 years old. A total of 2 pts did not have a postbaseline scan and were not included in the response-evaluable population (n=39). Tumor BRCA status: 4 (10%) pts had BRCAm, 32 (82%) pts had BRCA wild-type (wt), and 3 (8%) pts were unknown (unk). A total of 7 (18%) pts had HRRm, 29 (74%) pts wt, and 3 (8%) pts unk. ORR was 17.9% (95% CI 8.7–31.1; 0 confirmed complete responses [CR], 7 confirmed partial responses [PR]); DCR was 76.9% (23 stable disease, 7 PR, 0 CR). Median PFS was 7.6 mo (95% CI 4.2–10.6). Best percentage change in target lesion size by biomarker status is shown in the figure. ORR was similar across subgroups based on prior lines of therapy, tumor BRCA, or HRR status. However, ORR was lower in pts who had received prior bev (prior bev ORR 6% [95% CI 0.3–25.0]; no prior bev ORR 27% [95% CI 12.6–46.8]). The most common grade ≥3 treatment-emergent adverse events (TEAEs) were hypertension (22.0%), fatigue (17.1%), and anemia (17.1%). A total of 6 pts (14.6%) developed grade ≥3 small intestinal obstruction, all assessed as not related to study drug; 1 pt developed a grade 4 bowel perforation that was assessed as related to bev. The most common serious treatment-emergent adverse effects (TEAE) were thrombocytopenia (7.3%), anemia (4.9%), and hypertension (4.9%). A total of 34.1% of pts discontinued 1 of the 3 study drugs due to a TEAE. No TEAE resulted in death. [Display omitted] Conclusion: Triplet therapy with niraparib, dostarlimab, and bev is tolerable and demonstrated clinical activity in pts with PROC, most of which were BRCA or HRR wt. AEs were as expected. NCT03574779. GlaxoSmithKline. [ABSTRACT FROM AUTHOR]