Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.

Time frame: From randomization to the data cutoff date of 10 August 2020; up to 32.4 months

Population: The Intent-to-Treat (ITT) Analysis Set included all randomized patients

OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining).

The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is not at all and 4 is very much. Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.

Time frame: Baseline and Cycle 6 (each cycle was 3 weeks)

Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis.

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life.

Time frame: Baseline and Cycle 6 (each cycle was 3 weeks)

Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis.

The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Time frame: Baseline and Cycle 6 (each cycle was 3 weeks)

Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at Baseline and Cycle 6 are included in the analysis.

DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: Participants in the Intent-to-Treat Analysis Set who had an objective response

DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: Participants in the PD-L1-Positive Analysis Set who had an objective response

An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below: * Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. * Grade 3: Severe or medically significant but not immediately life threatening. hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living. * Grade 4: Life threatening consequences; urgent intervention indicated. * Grade 5: Death related to AE.

Time frame: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months)

Population: The Safety Analysis Set included all randomized patients who received ≥ 1 dose of study drug.

Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining).

Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: Intent-to-Treat Analysis Set

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: PD-L1 Positive Analysis Set

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Time frame: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Population: Intent-to-Treat Analysis Set