Trial Outcomes & Findings for A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer (NCT NCT04148911)

Last Updated: 2025-12-26

Results Overview

AE=untoward medical occurrence in participant administered a pharmaceutical product, regardless of causal attribution. AE=any unfavorable \& unintended sign, symptom/disease temporally associated with the use of pharmaceutical product, whether/not considered related to it. Severity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. Percentages have been rounded off.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2025-12-26

Participant Flow

Participants with unresectable locally advanced or metastatic programmed death-ligand 1 (PD-L1)-positive Triple-Negative Breast Cancer (TNBC) took part in the study at 67 centers in 13 countries from 10 Dec 2019 to 15 Dec 2024.

Participants received atezolizumab in combination with nab-paclitaxel until disease progression (PD) or unacceptable toxicity or loss of clinical benefit. A total of 184 participants were enrolled in the study. However, two participants discontinued the study before receiving any treatment. Hence, participant flow data is presented for 182 participants. All protocol-specified assessments were completed as planned. Hence, this study was considered to be completed.

Participant milestones

Participant milestones
Measure	Atezolizumab + Nab-paclitaxel Participants received atezolizumab 840 milligrams (mg) as intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 milligrams per square meter (mg/m\^2) as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Overall Study STARTED	182
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	182

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezolizumab + Nab-paclitaxel Participants received atezolizumab 840 milligrams (mg) as intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 milligrams per square meter (mg/m\^2) as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Overall Study Death	104
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	17
Overall Study Study Ended by Sponsor	56

Baseline Characteristics

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Age, Continuous	54.8 years STANDARD_DEVIATION 12.2 • n=30 Participants
Sex: Female, Male Female	182 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	17 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	1 Participants n=30 Participants
Race (NIH/OMB) White	146 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=30 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Percentage of Participants With Treatment-emergent Grade ≥3 Adverse Events (AEs)	46.70 percentage of participants Interval 39.29 to 54.23

PRIMARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel). Percentages have been rounded off.

AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. AE=any unfavorable and unintended sign, symptom/disease temporally associated with the use of a pharmaceutical product, whether/not considered related to it. Severity was graded according to NCI CTCAE v5.0. Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living (ADL); Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; or limiting self-care ADL; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. imAEs are events that resemble autoimmune diseases and are known side effects of immune checkpoint inhibitors.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Percentage of Participants With Treatment-emergent Grade ≥2 Immune-mediated AEs (imAEs)	12.09 percentage of participants Interval 7.73 to 17.73

SECONDARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the PP. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Percentage of Participants With All Treatment-emergent AEs	95.60 percentage of participants Interval 91.52 to 98.08

SECONDARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

An AE was any untoward medical occurrence in a participant administered a PP and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the PP. SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Percentage of Participants With All Treatment-emergent Serious Adverse Events (SAEs)	16.48 percentage of participants Interval 11.41 to 22.69

SECONDARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using Kaplan-Meier (K-M) method.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Overall Survival (OS) in Safety-evaluable Population	27.0 months Interval 22.0 to 33.8

SECONDARY outcome

Timeframe: Up to 60 months

Population: PD-L1 positive population included all participants with centrally confirmed PD-L1 positive tumor status.

OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using K-M method.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=66 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
OS in PD-L1-positive Population	NA months Interval 29.4 to Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 60 months

Population: Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

PFS was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), and must also demonstrate an absolute increase of ≥ 5 millimeters (mm). PFS was estimated using K-M method.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=182 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Progression Free Survival (PFS) in Safety-evaluable Population	7.4 months Interval 5.6 to 10.6

SECONDARY outcome

Timeframe: Up to 60 months

Population: PD-L1 positive population included all participants with centrally confirmed PD-L1 positive tumor status.

PFS was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), and must also demonstrate an absolute increase of ≥ 5 mm. PFS was estimated using K-M method.

Outcome measures

Outcome measures
Measure	Atezolizumab + Nab-paclitaxel n=66 Participants Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
PFS in PD-L1-positive Population	11.1 months Interval 7.4 to 16.8

Adverse Events

Atezolizumab + Nab-paclitaxel

Serious events: 30 serious events

Other events: 167 other events

Deaths: 104 deaths

Serious adverse events

Serious adverse events
Measure	Atezolizumab + Nab-paclitaxel n=182 participants at risk Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Investigations Transaminases increased	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations White blood cell count decreased	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Metabolism and nutrition disorders Dehydration	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Metabolism and nutrition disorders Electrolyte imbalance	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Renal and urinary disorders Urinary tract obstruction	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Cardiac disorders Cardio-respiratory arrest	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Endocrine disorders Adrenal insufficiency	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Colitis	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Diverticular perforation	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Dysphagia	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Chest pain	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Device related thrombosis	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Fatigue	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Oedema peripheral	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Pyrexia	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Hepatobiliary disorders Hepatic failure	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Device related sepsis	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Infected skin ulcer	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Myelitis	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Pneumonia	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Postoperative wound infection	1.1% 2/182 • Number of events 3 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Skin infection	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Soft tissue infection	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Subcutaneous abscess	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Vascular device infection	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Injury, poisoning and procedural complications Subdural haematoma	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Injury, poisoning and procedural complications Vascular access site inflammation	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations Blood creatinine increased	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 3/182 • Number of events 3 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Metabolism and nutrition disorders Hypokalaemia	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.55% 1/182 • Number of events 1 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

Other adverse events

Other adverse events
Measure	Atezolizumab + Nab-paclitaxel n=182 participants at risk Participants received atezolizumab 840 mg as IV infusion on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, 100 mg/m\^2 as IV infusion on Days 1, 8 and 15 of each 28-day cycle until PD, unacceptable toxicity, loss of clinical benefit or participant or investigator decision to discontinue treatment.
Investigations Blood alkaline phosphatase increased	6.0% 11/182 • Number of events 18 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations Blood lactate dehydrogenase increased	7.1% 13/182 • Number of events 14 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations Neutrophil count decreased	8.2% 15/182 • Number of events 82 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations White blood cell count decreased	9.9% 18/182 • Number of events 60 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Metabolism and nutrition disorders Decreased appetite	8.2% 15/182 • Number of events 19 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Metabolism and nutrition disorders Hypokalaemia	5.5% 10/182 • Number of events 11 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Musculoskeletal and connective tissue disorders Arthralgia	16.5% 30/182 • Number of events 37 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Musculoskeletal and connective tissue disorders Back pain	10.4% 19/182 • Number of events 20 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Musculoskeletal and connective tissue disorders Bone pain	5.5% 10/182 • Number of events 12 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Musculoskeletal and connective tissue disorders Myalgia	16.5% 30/182 • Number of events 47 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Musculoskeletal and connective tissue disorders Pain in extremity	9.3% 17/182 • Number of events 17 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Nervous system disorders Dizziness	7.1% 13/182 • Number of events 13 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Nervous system disorders Dysgeusia	6.6% 12/182 • Number of events 13 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Nervous system disorders Headache	13.2% 24/182 • Number of events 28 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Nervous system disorders Neuropathy peripheral	13.2% 24/182 • Number of events 32 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Nervous system disorders Paraesthesia	14.8% 27/182 • Number of events 33 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Psychiatric disorders Insomnia	5.5% 10/182 • Number of events 12 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Reproductive system and breast disorders Breast pain	5.5% 10/182 • Number of events 11 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Cough	10.4% 19/182 • Number of events 24 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.0% 11/182 • Number of events 12 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Skin and subcutaneous tissue disorders Alopecia	39.6% 72/182 • Number of events 73 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Skin and subcutaneous tissue disorders Erythema	7.7% 14/182 • Number of events 18 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Skin and subcutaneous tissue disorders Pruritus	7.7% 14/182 • Number of events 18 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Skin and subcutaneous tissue disorders Rash	12.1% 22/182 • Number of events 26 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Vascular disorders Hypertension	5.5% 10/182 • Number of events 10 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Vascular disorders Lymphoedema	6.6% 12/182 • Number of events 12 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations Aspartate aminotransferase increased	13.2% 24/182 • Number of events 32 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Blood and lymphatic system disorders Anaemia	37.4% 68/182 • Number of events 160 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Blood and lymphatic system disorders Leukopenia	14.8% 27/182 • Number of events 45 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Blood and lymphatic system disorders Neutropenia	24.2% 44/182 • Number of events 118 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Endocrine disorders Hyperthyroidism	7.7% 14/182 • Number of events 15 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Endocrine disorders Hypothyroidism	18.7% 34/182 • Number of events 40 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Abdominal pain	6.6% 12/182 • Number of events 12 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Abdominal pain upper	6.6% 12/182 • Number of events 16 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Constipation	18.7% 34/182 • Number of events 42 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Diarrhoea	26.9% 49/182 • Number of events 73 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Dyspepsia	5.5% 10/182 • Number of events 16 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Nausea	27.5% 50/182 • Number of events 87 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Gastrointestinal disorders Vomiting	12.1% 22/182 • Number of events 33 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Asthenia	33.5% 61/182 • Number of events 106 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Fatigue	18.7% 34/182 • Number of events 50 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Mucosal inflammation	7.7% 14/182 • Number of events 21 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Oedema peripheral	8.2% 15/182 • Number of events 25 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
General disorders Pyrexia	17.6% 32/182 • Number of events 42 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations COVID-19	15.4% 28/182 • Number of events 31 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Infections and infestations Urinary tract infection	9.9% 18/182 • Number of events 21 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).
Investigations Alanine aminotransferase increased	15.9% 29/182 • Number of events 53 • Up to 60 months Safety-evaluable population included all enrolled participants who had received at least one dose of any study treatment (atezolizumab/nab-paclitaxel).

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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