KAZ954 + PDR001

KAZ954 + NIR178

KAZ954 + NZV930

ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST). For iRECIST, the principles used to determine objective tumor response are largely unchanged from RECIST v1.1, while the major change of iRECIST is the concept of 'resetting the bar' if RECIST v1.1 progression is followed by tumor shrinkage. Unlike RECIST v1.1, iRECIST requires the confirmation of progression.

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD), based on local investigator assessment per immune-related RECIST (iRECIST). For iRECIST, the principles used to determine objective tumor response are largely unchanged from RECIST v1.1, while the major change of iRECIST is the concept of 'resetting the bar' if RECIST v1.1 progression is followed by tumor shrinkage. Unlike RECIST v1.1, iRECIST requires the confirmation of progression.

For assessment per RECIST v1.1, PFS is the time from date of start of treatment to the date of event defined as the first progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was analyzed using the Kaplan-Meier method.

For assessment per iRECIST, iPFS is the time from date of start of treatment to the date of event defined as the first documented confirmed progression or death due to any cause. If a subject had not had an event, iPFS was censored at the date of last adequate tumor assessment. PFS was analyzed using the Kaplan-Meier method.

Pharmacokinetic (PK) parameters were calculated based on free KAZ954 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

PK parameters were calculated based on NIR178 and NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

PK parameters were calculated based on free KAZ954 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve (AUC) calculation.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

PK parameters were calculated based on NIR178 and NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

KAZ954 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:

• ADA-negative at baseline: ADA-negative sample at baseline
• ADA-positive at baseline: ADA-positive sample at baseline
• ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
• Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
• Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
• Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample

PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:

• ADA-negative at baseline: ADA-negative sample at baseline
• ADA-positive at baseline: ADA-positive sample at baseline
• ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
• Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
• Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
• Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample

Programmed Death-Ligand 1 (PD-L1) expression was assessed centrally using the 22C3 PharmDx assay. PD-L1 expression levels were defined based on the tumor proportion score (TPS). The PD-L1 expression levels were categorized as high (TPS ≥ 50%), medium (TPS 1% - 49%) and low (TPS <1%) expressors. ORR using RECIST v1.1 and iRECIST was summarized by PD-L1 expression.

Programmed Death-Ligand 1 (PD-L1) expression was assessed centrally using the 22C3 PharmDx assay. PD-L1 expression levels were defined based on the tumor proportion score (TPS). The PD-L1 expression levels were categorized as high (TPS ≥ 50%), medium (TPS 1% - 49%) and low (TPS <1%) expressors. PFS using RECIST v1.1 and iRECIST was summarized by PD-L1 expression.