Trial Outcomes & Findings for Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy (NCT NCT04249362)

Last Updated: 2025-01-10

Results Overview

The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment

Results posted on

2025-01-10

Participant Flow

Patients were enrolled and received study treatment at 29 sites in 5 countries (France, Italy, Poland, Russian Federation, and Spain). The data in this report are based on study start date (first patient enrolled: 26 November 2020 till final analyses data cut-off date of 06 December 2023.

Eligible patients who met all inclusion criteria were enrolled in the study. However, one patient was later found to have an important protocol deviation, and many other patients had protocol deviations. Study assessments followed scheduled timeline. Enrolled patients had Stage III unresectable Non-Small Cell Lung Cancer (NSCLC), an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2, had been treated with radiotherapy, and were ineligible for chemotherapy.

Participant milestones

Participant milestones
Measure	Durvalumab Cohort A: Standard Radiotherapy (RT) Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study STARTED	53	49
Overall Study COMPLETED	53	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Total n=102 Participants Total of all reporting groups
Age, Continuous	74.7 Years STANDARD_DEVIATION 9.18 • n=5 Participants	78.8 Years STANDARD_DEVIATION 6.71 • n=7 Participants	76.7 Years STANDARD_DEVIATION 8.32 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized White	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Missing	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs)	10 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Median Progression-free Survival (mPFS)	9.2 Months Interval 7.39 to 11.93	10.3 Months Interval 7.49 to 16.56	7.6 Months Interval 5.55 to 11.04

SECONDARY outcome

Timeframe: From the first date of treatment until the date of objective disease progression or death (6 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-free Survival at 6 Months (PFS6)	63.3 Percentage of patients Interval 52.62 to 72.25	67.1 Percentage of patients Interval 51.96 to 78.43	59.3 Percentage of patients Interval 43.38 to 72.07

SECONDARY outcome

Timeframe: From the first date of treatment until the date of objective disease progression or death (12 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-free Survival at 12 Months (PFS12)	39.6 Percentage of patients Interval 29.28 to 49.76	46.8 Percentage of patients Interval 31.88 to 60.36	31.8 Percentage of patients Interval 18.13 to 46.32

SECONDARY outcome

Timeframe: From the first date of treatment until death or data cut-off due to any cause (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Median Overall Survival (mOS)	21.1 Months Interval 14.75 to Upper limit of CI is not calculable due to insufficient number of patients with events.	21.1 Months Interval 11.6 to Upper limit of CI is not calculable due to insufficient number of patients with events.	16.8 Months Interval 10.64 to Upper limit of CI is not calculable due to insufficient number of patients with events.

SECONDARY outcome

Timeframe: From the first date of treatment until death due to any cause (12 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Survival at 12 Months (OS12)	64.7 Percentage of patients Interval 54.21 to 73.34	64.0 Percentage of patients Interval 49.01 to 75.58	65.5 Percentage of patients Interval 49.87 to 77.26

SECONDARY outcome

Timeframe: From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The ORR is the proportion (%) of patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria. CR is disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \< 10 mm. PR is at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Objective Response Rate (ORR)	29.4 Percentage of patients Interval 20.8 to 39.3	34.0 Percentage of patients Interval 21.5 to 48.3	24.5 Percentage of patients Interval 13.3 to 38.9

SECONDARY outcome

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. Number of participants analyzed and number analyzed here represents number of patients with objective response.

The DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=30 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=18 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=12 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Duration of Response (DoR)	56.9 Weeks Interval 31.14 to Upper limit of CI is not calculable due to insufficient number of patients with events.	56.9 Weeks Interval 31.0 to Upper limit of CI is not calculable due to insufficient number of patients with events.	34.1 Weeks Interval 24.29 to Upper limit of CI is not calculable due to insufficient number of patients with events.

SECONDARY outcome

Timeframe: From date of treatment start until death due to lung cancer (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The lung cancer mortality (NSCLC-related death) is assessed using the deaths which are reported as 'NSCLC-related' and is defined as the time (days) from the date of first dose of durvalumab until date of death due to lung cancer.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Lung Cancer Mortality	30.9 Months Interval 16.82 to Upper limit of CI is not calculable due to insufficient number of patients with events.	30.9 Months Interval 16.92 to Upper limit of CI is not calculable due to insufficient number of patients with events.	NA Months Interval 14.75 to Median and upper limit of CI is not calculable due to insufficient number of patients with events.

SECONDARY outcome

Timeframe: From screening (Day -28) till data cut-off (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed.

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Patients With Events (AEs) Any AE	99 Participants	50 Participants	49 Participants
Number of Patients With Events (AEs) Any PRAE (Investigator-assessed [IA])	62 Participants	31 Participants	31 Participants
Number of Patients With Events (AEs) Any AE of CTCAE Grade 3 or Grade 4, possibly related to durvalumab treatment (IA)	11 Participants	6 Participants	5 Participants
Number of Patients With Events (AEs) Any AE with outcome of death	7 Participants	5 Participants	2 Participants
Number of Patients With Events (AEs) Any AE with outcome of death, possibly related to treatment (IA)	1 Participants	1 Participants	0 Participants
Number of Patients With Events (AEs) Any SAE (including events with outcome of death)	41 Participants	23 Participants	18 Participants
Number of Patients With Events (AEs) Any AE leading to discontinuation of treatment	22 Participants	13 Participants	9 Participants
Number of Patients With Events (AEs) Any AE leading to treatment interruption	48 Participants	25 Participants	23 Participants
Number of Patients With Events (AEs) Any AEPI (including events with outcome of death), possibly related to treatment (IA)	29 Participants	14 Participants	15 Participants
Number of Patients With Events (AEs) Any imAE (IA)	51 Participants	27 Participants	24 Participants
Number of Patients With Events (AEs) Any AE of CTCAE Grade 3 or Grade 4	41 Participants	20 Participants	21 Participants
Number of Patients With Events (AEs) Any SAE (including events with outcome of death), possibly related to treatment (IA)	8 Participants	5 Participants	3 Participants
Number of Patients With Events (AEs) Any AE leading to discontinuation of treatment, possibly related to treatment (IA)	12 Participants	7 Participants	5 Participants
Number of Patients With Events (AEs) Any AE leading to treatment interruption, possibly related to treatment	13 Participants	6 Participants	7 Participants
Number of Patients With Events (AEs) Any AESI (including events with outcome of death) (IA)	46 Participants	25 Participants	21 Participants
Number of Patients With Events (AEs) Any AESI (including events with outcome of death), possibly related to treatment (IA)	33 Participants	19 Participants	14 Participants
Number of Patients With Events (AEs) Any Adverse event of potential interest (AEPI) (including events with outcome of death) (IA)	43 Participants	21 Participants	22 Participants
Number of Patients With Events (AEs) Any imAE, possibly related to treatment (IA)	50 Participants	26 Participants	24 Participants

SECONDARY outcome

Timeframe: From screening (Day -28) till data cut-off (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An AESI is an AE of scientific and medical interest specific to the understanding of durvalumab. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Here, number of patients experienced AESIs are presented. Serious adverse event of special interests (SAESIs).

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Patients With Adverse Events of Special Interests (AESIs) Any SAESIs, causally related to treatment	5 Participants	4 Participants	1 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Received systemic corticosteroids	13 Participants	5 Participants	8 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Received high dose steroids	10 Participants	4 Participants	6 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Event outcome resolved	25 Participants	13 Participants	12 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs	46 Participants	25 Participants	21 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4	5 Participants	4 Participants	1 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any SAESIs [including events with outcome = death])	5 Participants	4 Participants	1 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs with outcome = death	1 Participants	1 Participants	0 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs, causally related to treatment	33 Participants	19 Participants	14 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs of CTCAE Grade 3 or 4, causally related to treatment	5 Participants	4 Participants	1 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs with outcome = death, causally related to treatment	1 Participants	1 Participants	0 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Received endocrine therapy	11 Participants	6 Participants	5 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Received other immunosuppressants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) Any AESIs leading to discontinuation of durvalumab treatment	7 Participants	4 Participants	3 Participants
Number of Patients With Adverse Events of Special Interests (AESIs) AESIs: Event outcome not resolved	20 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: From screening (Day -28) till data cut-off (36 months)

Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.

The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate etiology. Here, number of patients experienced imAEs are presented. Immune-mediated serious adverse events (imSAEs)

Outcome measures

Outcome measures
Measure	Durvalumab Total n=102 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 Participants Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 Participants Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs of CTCAE Grade 3 or 4, causally related to treatment	5 Participants	2 Participants	3 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Received systemic corticosteroids	20 Participants	7 Participants	13 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Event outcome resolved	13 Participants	5 Participants	8 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Received other immunosuppressants	0 Participants	0 Participants	0 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs	26 Participants	11 Participants	15 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4	5 Participants	2 Participants	3 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imSAEs [including events with outcome = death])	5 Participants	3 Participants	2 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs with outcome = death	1 Participants	1 Participants	0 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs, causally related to treatment	22 Participants	10 Participants	12 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imSAEs, causally related to treatment	5 Participants	3 Participants	2 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs with outcome = death, causally related to treatment	1 Participants	1 Participants	0 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Received high dose steroids	12 Participants	5 Participants	7 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Received endocrine therapy	11 Participants	6 Participants	5 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) Any imAEs leading to discontinuation of durvalumab treatment	7 Participants	3 Participants	4 Participants
Number of Patients With Immune-mediated Adverse Events (imAEs) imAEs: Event outcome not resolved	12 Participants	5 Participants	7 Participants

Adverse Events

Durvalumab Cohort A: Standard Radiotherapy (RT)

Serious events: 23 serious events

Other events: 47 other events

Deaths: 23 deaths

Durvaumab Cohort B: Palliative Radiotherapy (RT)

Serious events: 18 serious events

Other events: 45 other events

Deaths: 23 deaths

Durvalumab Total

Serious events: 41 serious events

Other events: 92 other events

Deaths: 46 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
Publication restrictions are in place

Restriction type: OTHER

Measure	Durvalumab Cohort A: Standard Radiotherapy (RT) n=53 participants at risk Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)\] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvaumab Cohort B: Palliative Radiotherapy (RT) n=49 participants at risk Patients who received palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Durvalumab Total n=102 participants at risk Patients who received standard RT \[60 gray (GY) ± 10% or hypofractionated BED)\] or palliative RT \[40 to \< 54 Gy or hypofractionated BED\] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Infections and infestations COVID-19 pneumonia	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Device related infection	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Enterobacter sepsis	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Pneumonia	5.7% 3/53 • Number of events 3 • From screening (Day -28) till data cut-off (36 months)	4.1% 2/49 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)	4.9% 5/102 • Number of events 5 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Pneumonia bacterial	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Pneumonia cytomegaloviral	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Infections and infestations Lower respiratory tract infection	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Endocrine disorders Hyperthyroidism	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Nervous system disorders Cerebral ischaemia	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Nervous system disorders Ischaemic stroke	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Nervous system disorders Syncope	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Cardiac disorders Atrial fibrillation	3.8% 2/53 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	2.0% 2/102 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)
Cardiac disorders Cardiac failure	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	8.2% 4/49 • Number of events 4 • From screening (Day -28) till data cut-off (36 months)	4.9% 5/102 • Number of events 5 • From screening (Day -28) till data cut-off (36 months)
Cardiac disorders Left ventricular failure	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Cardiac disorders Myocarditis	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Vascular disorders Circulatory collapse	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Vascular disorders Hypotension	1.9% 1/53 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)
Vascular disorders Hypovolaemic shock	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 1/53 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	2.0% 2/102 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)
Gastrointestinal disorders Dysphagia	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Hepatobiliary disorders Hepatotoxicity	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Skin and subcutaneous tissue disorders Dermatomyositis	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Renal and urinary disorders Immune-mediated nephritis	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
General disorders Asthenia	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
General disorders Death	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	2.0% 2/102 • Number of events 2 • From screening (Day -28) till data cut-off (36 months)
General disorders General physical health deterioration	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
General disorders Pyrexia	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Investigations Aspartate aminotransferase increased	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Injury, poisoning and procedural complications Injury	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Injury, poisoning and procedural complications Subdural haemorrhage	1.9% 1/53 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.00% 0/49 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/53 • From screening (Day -28) till data cut-off (36 months)	2.0% 1/49 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)	0.98% 1/102 • Number of events 1 • From screening (Day -28) till data cut-off (36 months)