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Table 5 PARPi Maintenance by HRD Status

From: Maintenance therapy for recurrent epithelial ovarian cancer: current therapies and future perspectives – a review

Study Phase Patient population Treatment arms HR classification PFS/OS/ORR
Study 19 [12, 68] II Platinum-sensitive recurrent serous ovarian cancer; ≥2 PBC with PR or CR to most recent PBC olaparib 400 mg bid vs PBO Germline or tumor BRCA Ola: 74 (56%) vs PBO 62 (50%) PFS: ola: 11.2 months (BRCAm)/7.4 months (wt) p < 0.00001, For PBO: 4.3 months (BRCAm)/5.5 months (wt); p = 0.007
OS: BRCAm ola vs PBO 34.9 months (95% CI 29.2–54.6) vs 30.2 months (23.1–40.7); HR 0.62 (95% CI 0.41–0.94) nominal p = 0.025BRCAwt in11 (15%) of 74 patients with BRCAm who received ola maintenance for ≥5 years: ola vs PBO: 24.5 months (19.8–35.0) vs 26.6 months (23.1–32.5); HR 0.83 (95% CI 0.55–1.24); nominal p = 0.37
SOLO1 (NCT01844986) [11, 65] III Newly diagnosed HGSOC or endometrioid stage III and IV olaparib 300 mg bid vs PBO Of 391 patients at interim analysis, centrally confirmed gBRCA1/2 m: 388
somatic BRCA1/2 m: 2
PFS: Primary analysis: 60% vs. 27% in ola vs PBO (HR for disease progression or death, 0.30; 95% CI, 0.23 to 0.41; p < 0.001)
SOLO-2 [51] III PSROC HSG; ≥2 PBC olaparib 300 mg bid vs PBO gBRCAmut
BRCA1: Ola:132 (67%); PBO: 61 (62%)
BRCA2: Ola: 58 (30%); PBO: 35 (35%)
In 286 patients with BRCA1/2 (Ola: 190; PBO: 96). median PFS Ola vs PBO (19.3 months [95% CI 16.5–27.3] vs 5.5 months [5.0–5.8]; HR [in favor of ola] 0.33, 95% CI 0.24–0.44; p < 0.0001).
ENGOT-OV16/NOVA [52] III PSROC Niraparib 300 mg vs. PBO o.d BRCA1/2 positive & BRCA1/2 negative
gBRCA cohort: 203 (niraparib: 138,PBO: 65)
non-gBRCA cohort: 350 (niraparib: 234, PBO: 116
Median PFS gBRCAm 21 mo (nira) vs 5.5 months (PBO) (HR, 0.27; 95% confidence interval [CI], 0.17 to 0.41), p < 0.00001; Non-gBRCAm HRD+ 12.9 months (nira) versus 3.8 months (PBO) (HR 0.38 95% CI, 0.24 to 0.59), p < 0.00001; All Non-gBRCAm 9.3 months (nira) versus 3.9 months (PBO) (HR .45; 95% CI, 0.34 to 0.61), p < 0.00001
ARIEL3 (NCT01968213) [54, 69]
Ongoing; completion June 2020
III PSROC- HSGOC, ≥2 prior PBC with PR or CR to most recent PBC Rucaparib maintenance therapy 600 mg p.o. b.i.d. vs. PBO HRD stratification at the time of enrollment (BRCAmut; BRCAwt/ LOH high; BRCAwt/ LOH low)
BRCAm ruca: 130 [35%] vs PBO: 66 [35%]
HRD carcinoma ruca: 236 [63%] vs PBO: 118 [62%])
Median PFS in BRCA-mut rucaparib vs PBO 16.6 mo (95% CI 13.4–22.9) vs. 5.4 mo (95% CI 3.4–6.7) (HR 0.23 [95% CI 0.16–0.34]; p < 0.0001) HRD carcinoma ruca vs PBO: 13.6 mo (10.9–16.2) vs 5.4 mo (5.1–5.6; 0.32 [0.24–0.42]; p < 0.0001)
  1. Abbreviations: AE adverse event, bid. twice daily, od once daily, p.o. orally or per mouth, chemo chemotherapy, HRD homologous recombination deficiency, HR hazard ratio, IV intravenous, LOH loss of heterozygosity, mut mutated, N/A not available, mo months, ORR overall response rate, PARP Poly (ADP-ribose) polymerase, PFS progression-free survival, po. by mouth, wt wild type, gBRCA germline BRCA mutation, non-gBRCA non-germline BRCA mutation, PSROC platinum sensitive recurrent ovarian cancer, HR hazard ratio, PBC platinum based chemotherapy, Ola olaparib;nira: niraparib; ruca: rucaparib, PBO placebo, PR partial response, CR complete response