Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)

CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

GFR is an index of kidney function that describes the flow of filtered fluid through the kidney. eGFR was reported in millimeter per minute per 1.73 square meter (ml/min/1.73 m\^2).

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure participants were reported as Yes or No according to presence of complications.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Participants whose score was not known were reported against Unknown'.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \*400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \*100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against Unknown'.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure participants were reported according to the different histological type of mRCC including clear renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma and others.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (\<) 80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium; neutrophils and platelets more than (\>) upper limit of normal (ULN); hemoglobin \<lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (more than or equal to \[\>=\]3 factors).

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure participants were reported according to number of metastatic organs as a) 1 and, b) 2 or more.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, participants were categorized as Yes or No according to presence of sarcomatoid component were reported.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants with smoking history were reported as No (No smoking history, never smoked), No (Smoking history exists, quit smoking), Yes (currently smoking). Participant whose smoking status was not known were reported against Unknown.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor \<=20 millimeters (mm), T2: tumor \>20 mm to \<=50 mm, T3: \>50 mm and TX: tumor cannot be assessed. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven \>0.2 mm, and MX: metastases cannot be assessed.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Sites of metastases included: metastases of lung, liver, bone, brain, regional lymph nodes, distant nodal metastases and others. One participant could have more than 1 type of metastases.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, participants who took concomitant drugs were reported.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants who underwent nephrectomy previously, were reported as Yes' or No.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative = \<15 milligrams per deciliter (mg/dL), positive=15-29 mg/dL, 1 = 30 mg/dL, 2= 100 mg/dL, 3= 300 mg/dL.

Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Immune-related adverse events (irAEs) was defined as the serious side effect of immune checkpoint inhibitor therapy for participants with advanced cancer.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were reported against the reasons for dose modification of axitinib treatment. One participant could have more than 1 reason for modification of axitinib treatment.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who received subsequent treatment after avelumab plus axitinib therapy, were reported according to type of subsequent treatment including tyrosine kinase inhibitors (TKI), immuno-oncology (IO) drugs and others. Categories with at least 1 non-zero data are reported below.

Time frame: From avelumab plus axitinib end of treatment to end of study observation (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported according to type of pre-medications. One participant could have taken more than 1 type of pre-medication.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who received any treatment for infusion-related reaction of avelumab were reported.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who discontinued and had interruption of avelumab and axitinib treatment were reported.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants who had dose modification (increase/decrease) were reported.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participant who discontinued the avelumab treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, participant who discontinued the axitinib treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Objective response was defined as percentage of participants with complete response (CR) or partial response (PR) as the best adjudication result in a method complied with RECIST version. 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgment. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Time frame: From avelumab plus axitinib initiation to CR or PR (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point.

PFS was defined as time from start of avelumab/axitinib treatment to date of first disease progression (DP) (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever came first. If there were no clinical records of death or disease progression, they were censored at the date of initiation of the next line of therapy for the participants undertaking 2 or more lines of therapy based on the record, or at their last visit date during the study period for the participants undertaking only 1 line of therapy based on the record.

Time frame: From avelumab plus axitinib initiation to disease progression or death due to any cause/censored date (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approx 1.6 years]); retrieved data was analyzed during 4.5 months of this OS

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TTF was defined as the time from the date of first dose of avelumab plus axitinib to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.

Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TTF was defined as the time from the date of first dose of avelumab plus axitinib as first line therapy to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.

Time frame: From index date up to 20-June-2021, where index date was date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020 (maximum observation period was of 1.5 years approximately).

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.