Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) (NCT NCT02425891)

Last Updated: 2022-07-19

Results Overview

PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

902 participants

Primary outcome timeframe

Baseline up to approximately 34 months

Results posted on

2022-07-19

Participant Flow

The observation of Overall Survival events was complete. Participants still on treatment were handed over to follow-up programs or studies. The study status is "Completed" but some participants discontinued the study because the Sponsor terminated it after it reached the "Completed" state.

Participant milestones

Participant milestones
Measure	Placebo Plus Nab-Paclitaxel Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Overall Study STARTED	451	451
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	451	451

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Plus Nab-Paclitaxel Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Overall Study Death	333	314
Overall Study Lost to Follow-up	4	6
Overall Study Non-Compliance	1	1
Overall Study Accidentally randomized screen failure participant	0	1
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	1
Overall Study Study Terminated By Sponsor	85	95
Overall Study Withdrawal by Subject	27	32

Baseline Characteristics

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Plus Nab-Paclitaxel n=451 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=451 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Total n=902 Participants Total of all reporting groups
Age, Continuous	55.4 Years STANDARD_DEVIATION 12.1 • n=5 Participants	54.3 Years STANDARD_DEVIATION 12.3 • n=7 Participants	54.9 Years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	450 Participants n=5 Participants	449 Participants n=7 Participants	899 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	83 Participants n=5 Participants	60 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	340 Participants n=5 Participants	368 Participants n=7 Participants	708 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) Asian	76 Participants n=5 Participants	85 Participants n=7 Participants	161 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	301 Participants n=5 Participants	308 Participants n=7 Participants	609 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=451 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=451 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants	5.49 Months Interval 5.32 to 5.59	7.16 Months Interval 5.59 to 7.46

PRIMARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=184 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=185 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)	4.96 Months Interval 3.81 to 5.55	7.46 Months Interval 6.7 to 9.23

PRIMARY outcome

Timeframe: Baseline until death due to any cause (up to approximately 58 months)

Population: The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

OS was defined as the time from the date of randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=451 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=451 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Overall Survival (OS) in All Randomized Participants	18.73 Months Interval 16.85 to 20.76	21.03 Months Interval 19.02 to 23.36

PRIMARY outcome

Timeframe: Baseline until death due to any cause (up to approximately 58 months)

Population: The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

OS was defined as the time from the date of randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=184 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=185 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
OS in Participants With Detectable PD-L1	17.91 Months Interval 13.63 to 20.3	25.43 Months Interval 19.55 to 30.69

SECONDARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline.

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=449 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=450 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants	45.9 Percentage of Participants	56.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=183 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=185 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1	42.6 Percentage of participants	58.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The duration of response (DOR)-evaluable population is defined as patients with an objective response.

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=206 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=252 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants	5.62 Months Interval 5.52 to 6.93	7.39 Months Interval 6.9 to 9.0

SECONDARY outcome

Timeframe: Baseline up to approximately 34 months

Population: The duration of response (DOR)-evaluable population is defined as patients with an objective response.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=78 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=109 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1	5.49 Months Interval 3.71 to 7.13	8.48 Months Interval 7.33 to 9.66

SECONDARY outcome

Timeframe: Baseline up to approximately 58 months

Population: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.

Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=400 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=406 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants	7.98 Months Interval 5.65 to 11.1	8.18 Months Interval 6.01 to 10.94

SECONDARY outcome

Timeframe: Baseline up to approximately 58 months

Population: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.

Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=160 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=167 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1	6.41 Months Interval 4.57 to 11.24	7.56 Months Interval 4.99 to 12.12

SECONDARY outcome

Timeframe: Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)

Population: The safety-evaluable population is defined as participants who received any amount of any study drug.

Percentage of participants with at least one adverse event.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=460 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=430 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Percentage of Participants With at Least One Adverse Event	99.3 Percentage of participants	97.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 53 months

Population: The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result.

Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=434 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab Baseline Prevalence of ADAs	1.6 Percentage of participants	—
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab Incidence of Treatment Emergent ADAs	13.1 Percentage of participants	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Maximum serum concentration for atezolizumab.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=407 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Maximum Serum Concentration (Cmax) for Atezolizumab	329 µg/mL Standard Deviation 98.9	—

SECONDARY outcome

Timeframe: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Minimum serum concentration for atezolizumab.

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=420 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Minimum Serum Concentration (Cmin) for Atezolizumab Cycle 1 Day 27	145 µg/mL Standard Deviation 52.6	—
Minimum Serum Concentration (Cmin) for Atezolizumab Cycle 2 Day 27	215 µg/mL Standard Deviation 78.3	—
Minimum Serum Concentration (Cmin) for Atezolizumab Cycle 3 Day 27	245 µg/mL Standard Deviation 90.3	—
Minimum Serum Concentration (Cmin) for Atezolizumab Cycle 7 Day 27	274 µg/mL Standard Deviation 111	—

SECONDARY outcome

Timeframe: Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)

Population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Plasma Concentrations of Total Paclitaxel

Outcome measures

Outcome measures
Measure	Placebo Plus Nab-Paclitaxel n=321 Participants Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	Atezolizumab Plus Nab-Paclitaxel n=436 Participants Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Plasma Concentrations of Total Paclitaxel C1D1/Predose	NA ng/mL Standard Deviation NA Cycle 1 predose is before study drug treatment.	NA ng/mL Standard Deviation NA Cycle 1 predose is before study drug treatment.
Plasma Concentrations of Total Paclitaxel C3D1/Predose	NA ng/mL Standard Deviation NA Below the level of detection as expected given the half-life of 13-27 hours per abraxane product label.	NA ng/mL Standard Deviation NA Below the level of detection as expected given the half-life of 13-27 hours per abraxane product label.
Plasma Concentrations of Total Paclitaxel C3D1/ Before End of Infusion	2970 ng/mL Standard Deviation 2300	3080 ng/mL Standard Deviation 2050
Plasma Concentrations of Total Paclitaxel C3D1/Postdose Paclit	370 ng/mL Standard Deviation 244	400 ng/mL Standard Deviation 275

Adverse Events

Placebo (q2w) + Nab-Paclitaxel

Serious events: 80 serious events

Other events: 414 other events

Deaths: 333 deaths

Atezolizumab (q2w) + Nab-Paclitaxel

Serious events: 110 serious events

Other events: 450 other events

Deaths: 314 deaths

Serious adverse events

Other adverse events

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