A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)

• ClinicalTrials.gov Identifier: NCT03219333
• Recruitment Status: Active, not recruiting
• First Posted: July 17, 2017
• Results First Posted: December 17, 2021
• Last Update Posted: June 15, 2022
• Sponsor: Astellas Pharma Inc
• Collaborator: Seagen Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc

Tracking Information

• First Submitted Date: July 13, 2017
• First Posted Date: July 17, 2017
• Results First Submitted Date: October 26, 2021
• Results First Posted Date: December 17, 2021
• Last Update Posted Date: June 15, 2022
• Actual Study Start Date: October 8, 2017
• Actual Primary Completion Date: October 27, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2021)

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]

The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Original Primary Outcome Measures (submitted: July 13, 2017)

Objective response rate (ORR) by an independent review facility (IRF) [ Time Frame: Up to 2 years ]

The proportion of patients with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Current Secondary Outcome Measures (submitted: December 16, 2021)

• Duration of Objective Response (DOR) Per BICR [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology.
• Progression-Free Survival (PFS) Per BICR [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.
• ORR Per Investigator Assessment [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR and PR are defined in the ORR per BICR endpoint.
• DOR Per Investigator Assessment [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD is defined in the DOR per BICR endpoint.
• PFS Per Investigator Assessment [ Time Frame: Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.
• Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology) [ Time Frame: Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]). ]
  A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
• Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry) [ Time Frame: Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]). ]
  A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
• Incidence of Antitherapeutic Antibody (ATA) [ Time Frame: Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]). ]
  Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if >=2 consecutive samples were confirmed as positive.
• Disease Control Rate at 16 Weeks (DCR16) Per BICR [ Time Frame: Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2. ]
  Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
• DCR16 Per Investigator Assessment [ Time Frame: Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2. ]
  Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD is defined in DCR16 per BICR endpoint.
• Overall Survival (OS) at Time of Primary Analysis [ Time Frame: Up to data cut-off date of 08 Sept 2020 (Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). ]
  OS is defined as the time from first dose of enfortumab vedotin to death from any cause. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.
• Number of Participants With Adverse Events (AEs) at Time of Primary Analysis [ Time Frame: Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]). ]
  An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.
• Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose). ]
  AUC was derived from the PK blood samples collected.
• PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for Free MMAE: Tmax (Plasma) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for Free MMAE: AUC (Plasma) [ Time Frame: Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose). ]
  AUC was derived from the PK blood samples collected.
• PK Parameter for Total Antibody (TAb): Cmax (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for TAb: Tmax (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22. ]
  Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
• PK Parameter for TAb: AUC (Serum) [ Time Frame: Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose). ]
  AUC was derived from the PK blood samples collected.
• Overall Survival (OS) [ Time Frame: Updated Time Frame description will be provided at study completion. ]
• Number of Participants With Adverse Events (AEs) [ Time Frame: Updated Time Frame description will be provided at study completion. ]
  An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment.

Original Secondary Outcome Measures (submitted: July 13, 2017)

• Duration of response (DOR) by an IRF [ Time Frame: Up to 6.5 years ]
  The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first
• Disease control rate at 16 weeks (DCR16) by an IRF [ Time Frame: 16 weeks ]
  Proportion of patients with CR, PR, or stable disease (SD) at Week 16 visit
• Progression free survival (PFS) by an IRF [ Time Frame: Up to 6.5 years ]
  The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first
• ORR by investigator assessment [ Time Frame: Up to 6.5 years ]
  Confirmed CR and PR per RECIST 1.1
• DOR by investigator assessment [ Time Frame: Up to 6.5 years ]
  The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or to death due to any cause, whichever comes first
• DCR16 by investigator assessment [ Time Frame: 16 weeks ]
  Proportion of patients with CR, PR, or SD at Week 16 visit
• Progression free survival (PFS) by investigator assessment [ Time Frame: Up to 6.5 years ]
  The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first
• Overall survival (OS) [ Time Frame: Up to 6.5 years ]
  The time from start of study treatment to date of death due to any cause
• Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Descriptive statistics will be used to summarize results
• Laboratory abnormalities [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Descriptive statistics will be used to summarize results
• Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Cmax will be derived from the PK blood samples collected
• PK parameter for enfortumab vedotin: Trough concentration (Ctrough) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Ctrough will be derived from the PK blood samples collected
• PK parameter for monomethyl auristatin E (MMAE): Cmax [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Cmax will be derived from the PK blood samples collected
• PK parameter for MMAE: Ctrough [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Ctrough will be derived from the PK blood samples collected
• Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years ]
  Blood samples for ATA analysis will be collected

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
• Official Title: A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

Brief Summary

This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer.

This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.

Patients who sign up for this trial must also fall into one of these categories:

• Patients have already received treatment with platinum-containing chemotherapy
• Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

Detailed Description

Japan Pharmaceuticals and Medical Devices Agency (PMDA) has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-naïve. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

single-arm, open-label, multi-cohort, multicenter study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urologic Neoplasms
• Renal Pelvis Neoplasms
• Urothelial Cancer
• Ureteral Neoplasms
• Urethral Neoplasms

Intervention

Drug: Enfortumab vedotin

Intravenous (IV) infusion on days 1, 8 and 15 every 28 days

Other Names:

• ASG-22CE
• ASG-22ME

Study Arms

Experimental: Enfortumab vedotin

Enfortumab vedotin on days 1, 8 and 15 every 28 days

Intervention: Drug: Enfortumab vedotin

Publications *

• McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12.
• Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12. Erratum In: Lancet Oncol. 2021 Jun;22(6):e239.
• Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 14, 2020): 219
• Original Estimated Enrollment (submitted: July 13, 2017): 120
• Estimated Study Completion Date: May 31, 2025
• Actual Primary Completion Date: October 27, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).
• Metastatic disease or locally advanced disease that is not resectable.
• Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
• Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment (Cohort 2).
• Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
• Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
• Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 for Cohort 1 or ≤2 for Cohort 2.
• Anticipated life expectancy of ≥3 months as assessed by the investigator.

Exclusion Criteria:

• Ongoing sensory or motor neuropathy Grade ≥2.
• Active central nervous system (CNS) metastases.
• Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
• Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
• Uncontrolled tumor-related pain or impending spinal cord compression.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT03219333
• Other Study ID Numbers: SGN22E-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Astellas Pharma Inc
• Original Responsible Party: Astellas Pharma Global Development, Inc.
• Current Study Sponsor: Astellas Pharma Inc
• Original Study Sponsor: Astellas Pharma Global Development, Inc.
• Collaborators: Seagen Inc.

Investigators

• Study Director: Janet Trowbridge, MD, PhD; Seagen Inc.

• PRS Account: Astellas Pharma Inc
• Verification Date: June 2022