Exploration of Immunology

Table 1

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 = 285 Cohort 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 m B: not reached	2.1 m	A: not reached B: 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 m Ave + PLD: 3.7 m PLD: 3.5 m	Ave: 8.2 Ave + PLD: 18.4 PLD: 17.4	≥ 3 S	[53]
	JAVELIN-100	Global, open label, three-arm, parallel, randomized, phase 3	Ave: n = 332 Chemotherapy + Ave: n = 331 Control: n = 335	Ave:chemotherapy + Ave:control = 1:1:1			Ave: 16.8 m Chemotherapy + Ave: 18.1 m Control: 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 = 38 PROC: n = 18 PSOC: n = 20	Niv + Bev	PROC: 16.7% PSOC: 40.0%		8.1 m		≥ 3 S	[71]
Anti-angiogenic drugs plus ICIs	ATALANTE/ENGOT-ov29	Randomized (2:1), double blinded, phase III, PSOC	n = 614 Atezolizumab: n = 410 Placebo: n = 204	Cx + Bev + At; Cx + Bev + placebo			At: 13.5 m Placebo: 11.3 m PD-L1-positive: 15.2 m vs. 13.1 m	At: 35.5 m Placebo: 30.6 m	≥ 3 S	[98]
PARP inhibitors plus ICIs	MEDIOLA	Multicenter, open-label, phase 1/2, basket trial	gBRCAm doublet: n = 51 Non-gBRCAm doublet: n = 32 Non-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]
PARP inhibitors plus ICIs	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 m Niv and ipilimumab: 31.4 m		Niv: 2 m Niv + ipilimumab: 3.9 m		≥ 3 S Niv: 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: uncertain Phase 2: 12.5%				Without significant toxicity	[90]

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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