Trial Outcomes & Findings for A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer (NCT NCT02999477)

Last Updated: 2026-01-29

Results Overview

PDL1 H-Score by Immunohistochemistry (≥ 100 versus 0-99) change from baseline biopsy to biopsy after 2-week monotherapy (from C1D1 to C3D1). The minimum score is 0 and the higher the score the worse.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

2 weeks

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Overall Study STARTED	16	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-Paclitaxel * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Overall Study found ineligible after first dose	0	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel n=15 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=14 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Total n=29 Participants Total of all reporting groups
Age, Continuous	46 years n=35 Participants	41.5 years n=4328 Participants	42 years n=8687 Participants
Sex: Female, Male Female	15 Participants n=35 Participants	14 Participants n=4328 Participants	29 Participants n=8687 Participants
Sex: Female, Male Male	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race/Ethnicity, Customized Race · White	14 Participants n=35 Participants	12 Participants n=4328 Participants	26 Participants n=8687 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=35 Participants	2 Participants n=4328 Participants	2 Participants n=8687 Participants
Race/Ethnicity, Customized Race · More than one race	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Ethnicity Hispanic or Latino	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Ethnicity Non-Hispanic	13 Participants n=35 Participants	13 Participants n=4328 Participants	26 Participants n=8687 Participants
Ethnicity Unknown	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
ECOG PS = 0 at Baseline	15 Participants n=35 Participants	14 Participants n=4328 Participants	29 Participants n=8687 Participants
Stage II	10 Participants n=35 Participants	10 Participants n=4328 Participants	20 Participants n=8687 Participants
Stage III	5 Participants n=35 Participants	4 Participants n=4328 Participants	9 Participants n=8687 Participants
T Stage T2	10 Participants n=35 Participants	10 Participants n=4328 Participants	20 Participants n=8687 Participants
T Stage T3	4 Participants n=35 Participants	4 Participants n=4328 Participants	8 Participants n=8687 Participants
T Stage T4	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
N Stage N0	5 Participants n=35 Participants	3 Participants n=4328 Participants	8 Participants n=8687 Participants
N Stage N1	10 Participants n=35 Participants	11 Participants n=4328 Participants	21 Participants n=8687 Participants
Hormone receptor status ER+/PR-	3 Participants n=35 Participants	1 Participants n=4328 Participants	4 Participants n=8687 Participants
Hormone receptor status ER+/PR+	9 Participants n=35 Participants	8 Participants n=4328 Participants	17 Participants n=8687 Participants
Hormone receptor status ER+/PR low+	1 Participants n=35 Participants	2 Participants n=4328 Participants	3 Participants n=8687 Participants
Hormone receptor status ER low+/PR-	2 Participants n=35 Participants	3 Participants n=4328 Participants	5 Participants n=8687 Participants
HER2 status negative	15 Participants n=35 Participants	14 Participants n=4328 Participants	29 Participants n=8687 Participants
HER2 status positive	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Size of breast tumor by physical exam (cm)	4 cm n=35 Participants	5 cm n=4328 Participants	4.5 cm n=8687 Participants
Histology Ductal	11 Participants n=35 Participants	11 Participants n=4328 Participants	22 Participants n=8687 Participants
Histology Lobular	3 Participants n=35 Participants	1 Participants n=4328 Participants	4 Participants n=8687 Participants
Histology Both	1 Participants n=35 Participants	2 Participants n=4328 Participants	3 Participants n=8687 Participants
Grade 1	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Grade 2	7 Participants n=35 Participants	7 Participants n=4328 Participants	14 Participants n=8687 Participants
Grade 3	7 Participants n=35 Participants	5 Participants n=4328 Participants	12 Participants n=8687 Participants
Grade Unknown	0 Participants n=35 Participants	1 Participants n=4328 Participants	1 Participants n=8687 Participants
Contralateral invasive breast ca at diagnosis Yes	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Contralateral invasive breast ca at diagnosis No	14 Participants n=35 Participants	14 Participants n=4328 Participants	28 Participants n=8687 Participants
Breast surgery Lumpectomy	6 Participants n=35 Participants	6 Participants n=4328 Participants	12 Participants n=8687 Participants
Breast surgery Mastectomy	8 Participants n=35 Participants	8 Participants n=4328 Participants	16 Participants n=8687 Participants
Breast surgery No breast surgery	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Adjuvant radiation Yes	11 Participants n=35 Participants	7 Participants n=4328 Participants	18 Participants n=8687 Participants
Adjuvant radiation No	4 Participants n=35 Participants	7 Participants n=4328 Participants	11 Participants n=8687 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Patients with biomarker sample available at both C1D1 and C3D1 time point.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=11 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=12 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Change in the Biomarker (PD-L1) Expression <100	11 Participants	12 Participants
Change in the Biomarker (PD-L1) Expression >=100	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from C1D1 to C3D1 (2 weeks)

Population: We are including patients who have biopsy both at C1D1 and C3D1.

stromal tumor infiltrating lymphocytes (sTIL) is measured at C1D1 and C3D1 of the treatment.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=10 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=10 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Change in Percentage of Stromal Tumor Infiltrating Lymphocytes After Monotherapy Treatment	7.2 percentage of stromal TILs Interval -65.0 to 60.0	0.5 percentage of stromal TILs Interval -10.0 to 15.0

SECONDARY outcome

Timeframe: 2 years

Response is measured by RCB score.RCB 0 (equal to pCR), RCB I(minimal burden), RCB II (moderate burden) and RCB III(extensive burden)

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=15 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=14 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Pathologic Complete Response Rate	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 19 patients (9 in Arm A and 10 in Arm B) who had MRI scans during study.

Overall response rate, assessed radiographically by both Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) following treatment with combination nab-paclitaxel and pembrolizumab in the neoadjuvant setting. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the baseline LD. Overall response = CR+PR+SD

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=9 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=10 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Overall Response Rate	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 years from randomization

Disease-free survival (DFS) will be defined from the time of randomization until the occurrence of the first of the following events: * Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast. * Contralateral invasive breast cancer, * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description. * Death from any cause

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel n=15 Participants * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab n=14 Participants * 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.
Disease-Free Survival	92 percentage of DFS patients Interval 79.0 to 100.0	100 percentage of DFS patients Interval 100.0 to 100.0

Adverse Events

Nab-Paclitaxel Run in

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Pembrolizumab Run in

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Post Monotherapy Nab-Paclitaxel and Pembrolizumab

Serious events: 4 serious events

Other events: 29 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Adrienne Waks, MD

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Nab-Paclitaxel Run in n=15 participants at risk * 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Pembrolizumab Run in n=15 participants at risk * 2 weeks Pembrolizumab Run in * Biopsy will be performed Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week. Biopsy: Biopsies for research purposes will be performed at three separate timepoints during treatment.	Post Monotherapy Nab-Paclitaxel and Pembrolizumab n=29 participants at risk * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks Pembrolizumab: Pembrolizumab will be administered in clinic every three weeks. Nab-Paclitaxel: Nab-Paclitaxel will be administered in clinic every week.
Investigations Neutrophil count decreased	6.7% 1/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Gastrointestinal disorders Colitis	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Gastrointestinal disorders Colonic perforation	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
General disorders Fever	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Infections and infestations Abdominal infection	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Infections and infestations Lung infection	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Investigations Alanine aminotransferase increased	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Investigations Aspartate aminotransferase increased	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	0.00% 0/15 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.	3.4% 1/29 • From randomization as early as 2017-06-02 to post surgery evaluation as late as 2022-10-27. (5 years and 4 months) The analysis population for mono therapy (nab) excluded two untreated patients. The analysis population for mono therapy (pem) excluded two untreated patients. The analysis population for combination (nab+pem) excluded three untreated patients.