Table 1 Criteria for Study Selection

Population(s)

Patients with bladder/urothelial cell, lung, gastric, or ovarian cancer

• Ongoing studies

• Interim analyses

• Studies of other oncology indications

Population criteria were designed to reflect cancer populations that are candidates for PD-L1 expression testing

Interventions/Comparators

Diagnostic tests targeting the PD-1/PD-L1 pathway

N/A

To survey the range of tests currently in use, all PD-L1 tests or studies looking at diagnostics used in PD-1/PD-L1 immunotherapy trials were considered

Outcomes

PD-L1 test-validation metrics.

Information on PD-L1 test-scoring algorithms or cutoffs was also captured from those studies that reported on test performance

Studies that did not report outcomes of interest for the study population

As the review aimed to evaluate how well different tests performed against validation criteria, studies reporting outcomes relating to validation metrics were prioritized. It was also considered important to capture data relating to the tests’ characteristics (scoring algorithms and test cutoffs) in order to determine the comparability of different tests

Time

Indexed databases: January 1 2010 to September 15, 2016)

Grey literature: Three most recent meetings (January 2013 up to November 2016).

Studies published prior to 2010 or after the final search date in 2016

Date limits were applied to reflect the very recent/current nature of this field of research

Study Design

• Randomized trials

• Observational studies

• Diagnostic or clinical validation studies

• Animal studies

• Case reports

• Editorials

Study design criteria reflected the nature of the studies reporting on test-validation metrics of PD-L1 tests for use in human population.

Other

PD-L1 tests required to be commercially available

• English language only

• Geographic emphasis on the US, EU5, and Japan

• Articles that were either not published in English or outside the geographic locations of interest

• Publications on noncommercially available tests

Commercially available tests were prioritized to ensure that review was relevant to current practice. The geographic emphasis reflects the countries in which PD-1/PD-L1 immunotherapies are currently licensed. Most evidence in this field is published in English so language limits were designed to reflect this.