Several clinical trials are currently underway to this investigate
Type | Study | Design | Population | Explorimental arm | ORR | DCR | mPFS (m) | OS (m) | AE/TEAE | Reference |
---|---|---|---|---|---|---|---|---|---|---|
ICIs monotherapy | JAVELIN | 1b, open label | n = 125 | Ave | 9.6% | 10.2% (y = 1) | 11.2 | 7.2% pts, 3–4 S | [41] | |
KEYNOTE-028 | Age ≥ 18 y, advanced, PD-L1 positivity | n = 26 | Pembrolizumab | 11.5% | 1.9 m | 13.8 | 19 (73.1%) pts, one grade 3 S | [44] | ||
KEYNOTE-100 | Phase II | Cohort A, n = 285Cohort A, n = 91 | Pembrlizumab | A 7.4%B 9.9%CPS+< 1 was 4.1%> 1 was 5.7%≥ 10 was 10.0% | A: 8.2 mB: not reached | 2.1 m | A: not reachedB: 17.6 | [45] | ||
NANT study | Prospective, multicenter, phase II, single arm | n = 127, HRD pts n = 67 | Niraparibb | HRD pts: 62.5%BRCAm pts: 77.3% | HRD pts: 87.5%BRCAm pts: 100% | ≥ 3 S | [97] | |||
Chemotherapy plus ICIs | JAVELIN-200 | An open-label, three-arm, randomized, phase 3 | n = 566 | Ave:Ave + PLD:PLD = 1:1:1 | Ave: 9 mAve + PLD: 3.7 mPLD: 3.5 m | Ave: 8.2Ave + PLD: 18.4PLD: 17.4 | ≥ 3 S | [53] | ||
JAVELIN-100 | Global, open label, three-arm, parallel, randomized, phase 3 | Ave: n = 332Chemotherapy + Ave: n = 331Control: n = 335 | Ave:chemotherapy + Ave:control = 1:1:1 | Ave: 16.8 mChemotherapy + Ave: 18.1 mControl: NE | Interruption | [54] | ||||
Combined pembrolizumab and PLD in PROC | Single arm, multi-center phase II | n = 26 | PLD + pembrolizumab | 26.1% | [55] | |||||
Anti-angiogenic drugs plus ICIs | Assessment of combined Niv and Bev in ROC | Single-arm, phase 2 | n = 38PROC: n = 18PSOC: n = 20 | Niv + Bev | PROC: 16.7%PSOC: 40.0% | 8.1 m | ≥ 3 S | [71] | ||
ATALANTE/ENGOT-ov29 | Randomized (2:1), double blinded, phase III, PSOC | n = 614Atezolizumab: n = 410Placebo: n = 204 | Cx + Bev + At; Cx + Bev + placebo | At: 13.5 mPlacebo: 11.3 mPD-L1-positive: 15.2 m vs. 13.1 m | At: 35.5 mPlacebo: 30.6 m | ≥ 3 S | [98] | |||
PARP inhibitors plus ICIs | MEDIOLA | Multicenter, open-label, phase 1/2, basket trial | gBRCAm doublet: n = 51Non-gBRCAm doublet: n = 32Non-gBRCAm triplet cohorts: n = 31 | Olaparib plus durvalumab, with or without Bev | gBRCAm expansion doublet 92.2% | (at 24 weeks) non-gBRCAm doublet: 28.1%Non-gBRCAm triplet cohorts: 74.2% | ≥ 3 S | [81, 99] | ||
Keynote-162 | Open-label, single-arm phases 1 and 2 study | n = 62 | Niraparib + pembrolizumab | 18% | 65% | 3 m | ≥ 3 S | [100, 101] | ||
ADCs plus ICIs | FORWARDII | Ib | MIRV + pembrolizumab | 43% | mDOR 6.9 m | 5.2 m | [80] | |||
PD-1 + CTLA-4 | NGR oncology study | Randomized phase II | Niv (n = 49)Niv and ipilimumab (n = 51) | Niv and ipilimumab | Niv: 12.2 mNiv and ipilimumab: 31.4 m | Niv: 2 mNiv + ipilimumab: 3.9 m | ≥ 3 SNiv: 3%Niv + ipilimumab: 49% | [88] | ||
Anti-CD27 antibody + anti-PD-1 | Agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (Niv) | Phase 1/2 dose-escalation and expansion | n = 175 (phase 1 n = 36; phase 2 n = 139) | Varlilumab and Niv | Phase 1: uncertainPhase 2: 12.5% | Without significant toxicity | [90] |
pts: patients; PD-L1: programmed cell death ligand 1; mPFS: median progression-free survival; ORR: objective response rate; OS: overall survival; mOS: median OS; DCR: disease control rate; mDOR: median duration of response; AE: adverse event; TRAEs: treatment-related AEs; n: number; PSOC: platinum-sensitive recurrent ovarian cancer; PROC: platinum-resistant recurrent ovarian cancer; Cx: platinum-based chemotherapy; Bev: bevacizumab; MIRV: mirvetuximab soravtansine; ADCs: antibody-drug conjugates; ICIs: immune checkpoint inhibitors; GEM/PLD: gemcitabine or pegylated liposomal doxorubicin; Ave: avelumab; Niv: nivolumab; m: months; y: years; CPS: combined positive score; NE: not evaluated; CTLA-4: cytotoxic T-lymphocyte antigen 4; PD-1: programmed cell death protein 1; HRD: homologous recombination deficiency; BRCAm: BRCA mutated; gBRCAm: germline BRCAm
GN: Writing—review & editing, Conceptualization. LZ: Writing—original draft, Investigation, Conceptualization. YZ: Data curation.
We declare that we have no conflicts of interest.
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This study was financially supported by grants from Science and Technology Tackling in Henan Province [242102310359]; and Henan Polytechnic University Youth Innovation Exploratory Fund [NSFRF230414]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
© The Author(s) 2024.