Table 1.

Disease indications, testing requirements and approved diagnostic scoring algorithms for approved programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) therapies.

ICI	Current indications	Testing requirements	Scoring cut-off	Indications
Pembrolizumab	NSCLC HNSCC UC G/GEJ Adenocarcinoma ESCC Cervical cancer MSI-Ha	PD-L1 IHC is required (companion)	≥1% TPS ≥1% CPS ≥10% CPS	1L for mNSCLC and unresectable stage III NSCLC 2L for mNSCLC 1L for unresectable HNSCC 2L for recurrent locally advanced or metastatic G/GEJ adenocarcinoma 2L for recurrent or metastatic cervical cancer 1L for locally advanced and metastatic UC 2L for recurrent locally advanced or metastatic ESCC
	Melanoma SCLC cHL PMBCL HCC MCC RCC	Testing is not required
Nivolumab	NSCLC HNSCC UC MSI-Ha	PD-L1 IHC is suggested (complementary)	≥1, 5 or 10% ≥1%	2L for non-squamous NSCLC 2L for HNSCC 2L for UC
	Cervical cancer HCC cHL RCC SCLC Melanoma	Testing is not required
Durvalumab	NSCLC UC	PD-L1 IHC is suggested (complementary)	≥1% TCs ≥25% TCs or ≥25% ICs and ICP>1% or ICP = 1% and IC = 100%	2L for unresectable NSCLC that has not progressed on chemoradiation 2L for locally advanced or metastatic UC
Atezolizumab	UC TNBC	PD-L1 IHC is required (companion)	≥1% ICs ≥5% ICs	1L for TNBC 1L for UC
	NSCLC	PD-L1 IHC is suggested (complementary)	≥50% TCs or ≥10% ICs ≥1% TCs or ≥1% ICs	1L for mNSCLC 2L for mNSCLC
	SCLC	Testing is not required

cHL, classical Hodgkin lymphoma; CPS, combined positive score; ESCC, squamous cell carcinoma of the esophagus; G/GEJ, gastric or gastroesophageal junction; HCC, hepatocellular carcinoma; HNSCC, head and neck squamous cell cancer; IC, immune cell; ICP, immune cells present; IHC, immunohistochemistry; MCC, Merkel cell carcinoma; MSI-H, microsatellite instability-high cancer; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; PMBCL, primary mediastinal large B-cell lymphoma; RCC, renal cell carcinoma; SCLC, small cell lung cancer; TC, tumour cell; TNBC, triple-negative breast cancer; TPS, tumor proportion score; UC, urothelial carcinoma; 1L, first-line; 2L, second- line.

^aOnly a positive test for MSI-H is required.