An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included both SAEs and non-serious AEs.

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grades of AEs were defined by NCI CTCAE v5.0. Grade 1 = asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

AEs in the first 28 d (days) following the first AdC68 vaccination that were considered possibly related to study treatment and not to disease/progression were DLTs: Grade≥3 neutropenia lasting>7 d, febrile neutropenia, Grade≥3 neutropenic infection, Grade≥3 thrombocytopenia with Grade≥2 clinically significant bleeding, Grade≥3 anemia lasting >7 d, Grade≥3 lymphopenia lasting>14 d; Grade≥3 lab abnormalities associated with symptoms or worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade≥3 AEs considered non-hematologic, non-hepatic major organ toxicity, Grade 3 flu-like symptoms lasting>3 d, fever of >40.0 degree Celsius lasting>3 d, concurrent aspartate aminotransferase or alanine aminotransferase >3x upper limit of normal (ULN) and total bilirubin >2x ULN (potential Hy's law case). Other clinically important or persistent toxicities at discretion of investigator and Pfizer.

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Laboratory abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Hematology parameters included hemoglobin, platelets, white blood cell (WBC) count, neutrophils, eosinophils, monocytes, basophils and lymphocytes. Coagulation should include prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (APTT).

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Chemistry abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Chemistry parameters included aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, total chloride, total calcium, total bilirubin, blood urea nitrogen (or urea), creatinine, uric acid, glucose (nonfasted), albumin, phosphorous or phosphate, lactate dehydrogenase, lipase, amylase, bicarbonate or carbon dioxide, total protein, TSH (reflex free T4 and free T3).

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Urinalysis abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Urine parameters included urine protein and urine blood.

The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Clinical Benefit Rate (CBR) is defined as the proportion of participants who achieved anti-tumor responses of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for >6 months. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. All target lesions must be assessed. SD: Does not qualify for CR, PR or Progression. SD can follow PR only in the rare case that the sum increases by <20% from the nadir, but enough that a previously documented 30% decrease no longer holds.

All enrolled participants who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis. This was a primary endpoint of Part 2. Part 2 of the study was never opened as the study terminated.

Cmax was defined as the maximum observed serum concentration.

According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Cmax was defined as the maximum observed serum concentration.

According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

Tmax was defined as the time to reach maximum observed serum concentration.

According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Tmax was defined as the time to reach maximum observed serum concentration.

According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

AUCinf was defined as area under the concentration time curve from time 0 extrapolated to infinity. AUCinf of sasanlimab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase. A well-characterized terminal phase was defined as one with at least 3 data points, r^2 ≥0.9, and percent of AUCextrap% ≤20%.

According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

AUCinf was defined as area under the concentration time curve from time 0 extrapolated to infinity. AUCinf of tremelimumab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase. A well-characterized terminal phase was defined as one with at least 3 data points, r^2 ≥0.9, and percent of AUCextrap% ≤20%.

According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

Ctrough was defined as the drug concentration observed at the last planned timepoint prior to dosing. Ctrough was not calculated for sasanlimab because trough concentration prior to the fifth dose (on Cycle 2 Day 1) were not collected for any participants in Cohorts 4A or 5A.

According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Ctrough was defined as the drug concentration observed at the last planned timepoint prior to dosing.

According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

ORR was defined as the percentage of participants with best overall response based assessment of CR or PR according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. All target lesions must be assessed.

All enrolled participants who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

PFS was defined as the time from start date to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after complete response or progression of pre-existing lesions.

All enrolled participants with NSCLC who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

PFS was defined as the time from start date to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after complete response or progression of pre existing lesions.

All enrolled participants with TNBC who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

Participants were considered ADA-positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted).

All enrolled participants who received at least 1 dose of the VBIR-2 component was the participant of the immunogenicity assessment (tremelimumab or sasanlimab). For this outcome measure, participants who received sasanlimab in Cohorts 4A, 5A and 6A were included.

A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted). Participants who were either (1) an ADA-negative participant or (2) an ADA-positive participant without treatment-induced or treatment-boosted NAb response were considered as NAb negative.

All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, NAb against sasanlimab was examined for the 2 participants with ADA positive samples at baseline in Cohort 6A.

Participants were considered ADA-positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted).

All enrolled participants who received at least 1 dose of the VBIR-2 component was the participant of the immunogenicity assessment (tremelimumab or sasanlimab). For this outcome measure, participants who received tremelimumab in Cohorts 3A, 4A, 5A and 6A were included.

A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted). Participants who were either (1) an ADA-negative participant or (2) an ADA-positive participant without treatment-induced or treatment-boosted NAb response were considered as NAb negative. NAb evaluation was not considered as meaningful taken that treatment-induced ADA was found in only 1 participant. Thus, NAb to tremelimumab was not examined.

All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis.

Titers were measured in terms of 1/dilution. Only the samples tested positive for ADA were to be further tested for Nab. Treatment-induced ADA: baseline titer is missing or negative and participant has >= 1 post-treatment positive titer. Treatment-induced NAb: baseline titer was missing or negative and participant had ≥1 post-treatment positive titer.

All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants who received sasanlimab in Cohorts 4A, 5A and 6A were included. No participants had treatment-induced ADA.

Titers were measured in terms of 1/dilution. Only the samples tested positive for ADA were to be further tested for Nab. Treatment-induced ADA: baseline titer is missing or negative and participant has >= 1 post-treatment positive titer. Treatment-induced NAb: baseline titer was missing or negative and participant had ≥1 post-treatment positive titer. NAb was not examined as the evaluation was not meaningful considering only 1 participant had treatment-induced ADA.

All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis.