Table 8.

Studies that explored the efficacy of immunotherapy in SGCs and median age of study populations.

First Author	Year	N. pts	Immunotherapy	Median age (range)	ORR (%)	Survival outcomes
Cohen (197) Phase Ib trial KEYNOTE-028	2018	26 AdCC and non-AdCC* PD-L1 expression on ≥1% of tumor or stroma cells required	Pembrolizumab 10 mg/kg i.v. every 2 weeks	57 (23 – 72)	12% n. 3 PR**	mPFS 4 months (95% CI: 2-5 months) mOS 13 months (95% CI 6 – NR)
		*Histotypes: adenocarcinoma NOS (38%), mucoepidermoid (12%), undifferentiated (8%), squamous cell (8%), and AdCC (8%). **PR observed in two adenocarcinoma NOS and in one high-grade serous carcinoma.
Fayette (198) Phase II trial NISCAHN	2019	52 Non-AdCC 46 AdCC	Nivolumab 3 mg/kg IV every 2 weeks up to 12 months	61 (29 – 81)	Non-AdCC: n.2 PR (3.8%) n.22 SD (42.3%) AdCC: n.4 PR (8.7%) n.26 SD (56.5%)	Non-progression rate at 6 months: 14% non-AdCC 33.3% AdCC
Rodriguez (199) Phase I/II trial	2020	25 n.12 AdCC n.3 AcCC n.3 MEC	• Vorinostat (HDAC) 400 mg given orally 5 days on and 2 days off during each 21-day cycle • Pembrolizumab 200 mg q21	61 (33 – 86)	16% (95% CI 5% - 37%) n.4 PR*** n.14 SD (10 SD > 6 months)	Median duration of treatment = 24 weeks; mDoR=10.5 months (8.7–21) mPFS 6.9 months mOS 14 months
		***PR observed in one patient with lymphoepithelioma-like carcinoma of the parotid, two patients with acinic cell carcinoma, and one patient with adenoid cystic carcinoma.
Burman (200) Phase II trial (NCT03172624)	2021	32 Non-AdCC	• Nivolumab 3 mg/kg q2 weeks • Ipilimumab 1 mg/kg q6 weeks until PD or intolerant toxicity	64.5 (30 – 87)	16% overall 25% in the SDC group (profound responses)	Duration of therapy from 15.7 to 29.5 months
Ferrarotto (201) Phase II trial NCT03990571	2022	28 AdCC	• Axitinib 5 mg po bid • Avelumab 10 mg/kg iv q2 weeks	55 (29 – 88)	17.5%	mPFS = 7.2 months (95% CI: 3.7-11.7) 6-mos PFS rate = 57% (95% CI_41-79%). mOS=17.4 months (95%CI:13-NA) mDOR=5.2 mos (95% CI: 3.7-NA)

HDAC, histone deacetylase inhibitors.