Table 3.

Clinical Trials Evaluating Nivolumab, Durvalumab, and Atezolizumab in R/M HNSCC

Trial	Phase	N	n	Treatment	PD-L1	Limit	ORR % (95% CI)			Median OS (Months, 95% CI)
							Total	PD-L1 +	PD-L1 -	Total	PD-L1 +	PD-L1 -
CHECKMATE-1418	III	361	240	Nivolumab	TC	≥1%	13.3 (9.3–18.3)	17.0%	12.3%	7.5 (5.5–9.1)	8.7	5.7 (4.4–12.7)
						≥5%		22.2%			8.8
						≥10%		27.9%			8.7
			121	SOC*	TC	≥1%	5.8 (2.4–11.6)			5.1 (4.0–6.0)	4.6	5.8 (4.0–9.8)
						≥5%					4.6
						≥10%					5.2
MEDI4736-110883	I/II	62	-	Durvalumab	TC	≥25%	6.5 (1.8–15.7)	15.0 (3.2–37.9)	2.6 (0.1–13.5)	8.4 (5.7–12.3)	8.4 (3.9–28.3)	7.4 (3.9–12.3)
CONDOR84	II	267	67	Durvalumab	TC	≤25	-	-	9.2 (3.46–19.02)	-	-	6.0 (4.0–11.3)
			133	Durvalumab + Tremelimumab	TC	≤25	-	-	7.8 (3.78–13.79)	-	-	7.6 (4.9–10.6)
			67	Tremelimumab	TC	≤25	-	-	1.6 (0.04–8.53)	-	-	5.5 (3.9–7.0)
HAWK49	II	111	-	Durvalumab	TC	≥25%	-	16.2 (9.9–24.4)	-	-	7.1 (4.9–9.9)	-
EAGLE85	III	727	240	Durvalumab	TC	≥25%	17.9 (13.3–23.3)	-	-	7.6 (6.1–9.8)	-	-
			247	Durvalumab + Tremelimumab	TC	≥25%	18.2 (13.6–23.6)	-	-	6.5 (5.5–8.2)	-	-
			249	SOC†	TC	≥25%	17.3 (12.8–22.6)	-	-	8.3 (7.3–9.2)	-	-
NCT0137584286	I	32	-	Atezolizumab‡	TC	≥5%¶	22 (9–40)	24 (9–45)	14 (0–58)	6.0 (0.5–51.5+)	-	-

Notes: *Investigator’s choice of single-agent methotrexate, docetaxel, or cetuximab. ^†Investigator’s choice of cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen. ^‡Atezolizumab administered every 3 weeks for at 15 mg/kg, 20 mg/kg or 1200 mg fixed-dose. ^¶The first 10 patients were non-selectively enrolled. Subsequent enrollment was based on PD-L1 status of >5% TC expression.

Abbreviations: TC, tumor cells; SOC, standard of care.