Trial Outcomes & Findings for A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT02848651)

NCT ID: NCT02848651

Last Updated: 2020-04-28

Results Overview

Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 153 participants
• Primary outcome timeframe: Baseline up to 32 months
• Results posted on: 2020-04-28

Participant Flow

Participant milestones

Measure	Atezolizumab Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Study STARTED	153
Overall Study Received Treatment	152
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	106

Reasons for withdrawal

Measure	Atezolizumab Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Study Death	85
Overall Study Lost to Follow-up	1
Overall Study Non-Compliance	1
Overall Study Symptomatic Deterioration	1
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	14

Baseline Characteristics

A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Age, Continuous	68.7 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	135 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 32 months

Population: Efficacy and Safety analysis Population included participants who received at least one dose of study drug.

Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.

Outcome measures

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator	17.1 Percentage of Participants Interval 11.62 to 23.86	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 32 months

Population: Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) \>= 1%.

Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.

Outcome measures

Measure	Atezolizumab n=91 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) n=28 Participants Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups	3.55 Months Interval 2.63 to 4.3	4.98 Months Interval 1.58 to 10.81	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 32 months

Population: Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.

Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.

Outcome measures

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator	4.14 Months Interval 2.76 to 4.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 32 months

Population: Duration of response included a subset of participants who achieved an objective response in the efficacy evaluable population.

Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first.

Outcome measures

Measure	Atezolizumab n=26 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator	16.33 Months Interval 10.15 to Upper limit is not available because at the time of data cutoff, the upper limit of 95% CI is not estimable.	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 32 months

Population: Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.

Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1.

Outcome measures

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator	32.9 Percentage Interval 25.5 to 40.74	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline until death (up to 32 months)

Population: Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.

OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.

Outcome measures

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Overall Survival (OS)	14.82 Months Interval 12.68 to 21.29	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 32 months

Population: Safety analyses population included all participants who received at least one dose of study drug.

Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.

Outcome measures

Measure	Atezolizumab n=152 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
Percentage of Participants With Adverse Events	100 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Months 6, 9, 12, and 18

Population: Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) \>=1%.

A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.

Outcome measures

Measure	Atezolizumab n=70 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) n=49 Participants Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 n=91 Participants Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 n=28 Participants Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 n=100 Participants Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 n=19 Participants Blood tumor mutational burden (bTMB) \>=20.
Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles 6 Months	35.67 Percentage of Participants Interval 23.91 to 47.43	34.69 Percentage of Participants Interval 21.37 to 48.02	32.85 Percentage of Participants Interval 22.85 to 42.86	42.86 Percentage of Participants Interval 24.53 to 61.19	31.91 Percentage of Participants Interval 22.47 to 41.34	52.63 Percentage of Participants Interval 30.18 to 75.08
Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles 9 Months	23.19 Percentage of Participants Interval 12.51 to 33.86	22.45 Percentage of Participants Interval 10.77 to 34.13	16.90 Percentage of Participants Interval 8.6 to 25.19	39.29 Percentage of Participants Interval 21.2 to 57.38	17.58 Percentage of Participants Interval 9.61 to 25.55	47.37 Percentage of Participants Interval 24.92 to 69.82
Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles 12 Months	16.86 Percentage of Participants Interval 6.99 to 26.74	14.29 Percentage of Participants Interval 4.49 to 24.08	12.29 Percentage of Participants Interval 4.79 to 19.78	25.00 Percentage of Participants Interval 8.96 to 41.04	12.24 Percentage of Participants Interval 5.17 to 19.31	31.58 Percentage of Participants Interval 10.68 to 52.48
Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles 18 Months	14.45 Percentage of Participants Interval 4.93 to 23.98	8.16 Percentage of Participants Interval 0.5 to 15.83	10.53 Percentage of Participants Interval 3.36 to 17.7	14.29 Percentage of Participants Interval 1.32 to 27.25	9.33 Percentage of Participants Interval 2.88 to 15.78	21.05 Percentage of Participants Interval 2.72 to 39.38

SECONDARY outcome

Timeframe: From baseline until death (up to 32 months)

Population: Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) \>= 1%.

OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.

Outcome measures

Measure	Atezolizumab n=91 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) n=28 Participants Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 n=100 Participants Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 n=19 Participants Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 Blood tumor mutational burden (bTMB) \>=20.
OS by Various bTMB Cutoff Points 16 and 20	13.37 Months Interval 11.7 to 18.0	23.85 Months Interval 8.77 to Upper limit is not available because at the time of data cutoff, the upper limit of 95% CI is not estimable.	13.14 Months Interval 10.48 to 17.71	23.85 Months Interval 15.7 to Upper limit is not available because at the time of data cutoff, the upper limit of 95% CI is not estimable.	—	—

SECONDARY outcome

Timeframe: Baseline up to 32 months

Population: Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) \>=1%.

Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.

Outcome measures

Measure	Atezolizumab n=70 Participants Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).	bTMB High (>=16) n=49 Participants Blood tumor mutational burden (bTMB) High (\>=16)	bTMB <16 n=91 Participants Blood tumor mutational burden (bTMB) \<16.	bTMB >=16 n=28 Participants Blood tumor mutational burden (bTMB) \>=16.	bTMB <20 n=100 Participants Blood tumor mutational burden (bTMB) \<20.	bTMB >=20 n=19 Participants Blood tumor mutational burden (bTMB) \>=20.
Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles	7.1 Percentage of Participants Interval 2.86 to 15.32	20.4 Percentage of Participants Interval 10.51 to 33.73	5.5 Percentage of Participants Interval 2.19 to 12.25	35.7 Percentage of Participants Interval 19.25 to 55.54	6.0 Percentage of Participants Interval 2.64 to 12.19	47.4 Percentage of Participants Interval 25.17 to 69.15

Adverse Events

Atezolizumab

Serious events: 81 serious events

Other events: 146 other events

Deaths: 85 deaths

Serious adverse events

Measure	Atezolizumab n=152 participants at risk Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Blood and lymphatic system disorders Anaemia	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Aortic valve stenosis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Atrial fibrillation	3.9% 6/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Atrioventricular block	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Cardiac arrest	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Endocrine disorders Adrenal insufficiency	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Abdominal pain	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Colitis	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Diarrhoea	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Gastritis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Gastrointestinal haemorrhage	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Immune-mediated enterocolitis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Peptic ulcer haemorrhage	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Vomiting	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Asthenia	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Death	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Non-cardiac chest pain	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Pyrexia	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Hepatobiliary disorders Bile duct obstruction	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Cellulitis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Clostridium difficile colitis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Infection	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Influenza	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Pneumonia	3.9% 6/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Sepsis	2.6% 4/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Septic Shock	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Upper respiratory tract infection	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Urinary tract infection	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Compression fracture	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Fall	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Infusion related reaction	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Seroma	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Dehydration	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Failure to thrive	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hyperglycaemia	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hypokalaemia	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hyponatraemia	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Back pain	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Muscular weakness	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Neck pain	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Pain in extremity	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Cerebrovascular accident	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Embolic stroke	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Syncope	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Psychiatric disorders Confusional state	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Psychiatric disorders Mental status changes	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Renal and urinary disorders Acute kidney injury	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Renal and urinary disorders Nephritis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.3% 5/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.2% 14/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.6% 7/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pulmonary artery occlusion	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 5/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Embolism	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Hypotension	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Peripheral embolism	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Peripheral ischaemia	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Cardiac failure	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Cardiac tamponade	1.3% 2/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Palpitations	0.66% 1/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Pericardial effusion	2.6% 4/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Cardiac disorders Supraventricular tachycardia	2.0% 3/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).

Other adverse events

Measure	Atezolizumab n=152 participants at risk Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
General disorders Fatigue	44.1% 67/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Oedema Peripheral	13.8% 21/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Pyrexia	7.9% 12/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Non-cardiac chest pain	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Chills	5.9% 9/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
General disorders Pain	5.3% 8/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Decreased appetite	27.0% 41/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hypokalaemia	17.1% 26/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hyponatraemia	14.5% 22/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hyperglycaemia	13.8% 21/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Dehydration	11.8% 18/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hypoalbuminaemia	11.8% 18/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Metabolism and nutrition disorders Hypomagnesaemia	11.2% 17/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Nausea	27.6% 42/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Diarrhoea	23.7% 36/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Constipation	19.1% 29/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Vomiting	11.2% 17/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Gastrointestinal disorders Abdominal pain	5.3% 8/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Arthralgia	20.4% 31/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Back pain	15.1% 23/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Myalgia	9.9% 15/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Musculoskeletal and connective tissue disorders Neck pain	5.3% 8/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Dyspnoea	24.3% 37/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Cough	21.7% 33/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Respiratory, thoracic and mediastinal disorders Productive cough	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Investigations Weight decreased	16.4% 25/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Investigations Blood alkaline phosphatase increased	9.2% 14/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Investigations Aspartate aminotransferase increased	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Investigations Alanine aminotransferase increased	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Investigations Blood creatinine increased	5.9% 9/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Dizziness	11.8% 18/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Headache	9.9% 15/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Nervous system disorders Dysgeusia	7.9% 12/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Psychiatric disorders Insomnia	15.1% 23/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Psychiatric disorders Depression	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Psychiatric disorders Anxiety	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Skin and subcutaneous tissue disorders Pruritus	9.9% 15/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Skin and subcutaneous tissue disorders Rash maculo-papular	9.9% 15/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Skin and subcutaneous tissue disorders Dry skin	9.2% 14/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Urinary tract infection	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Upper respiratory tract infection	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Infections and infestations Pneumonia	5.9% 9/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Blood and lymphatic system disorders Anaemia	15.8% 24/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Hypotension	7.2% 11/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Vascular disorders Hypertension	6.6% 10/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Endocrine disorders Hypothyroidism	8.6% 13/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).
Injury, poisoning and procedural complications Infusion related reaction	5.3% 8/152 • Baseline up to approximately 3 years (data cut off 26 July 2019).

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER