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Jemperli

(Dostarlimab)

Phase 3Monoclonal antibody

GGlaxo Dba Glaxosmithkline

Dostarlimab is used to treat certain types of cancer, specifically endometrial cancer (cancer of the uterus lining) that has a specific genetic marker called mismatch repair deficiency. It works by helping the immune system recognize and attack cancer cells.[1] Jemperli is currently being investigated across 30 indications[3], with its most advanced program in Phase 3.[1]

Jemperli is one of 542 small molecule programs targeting Head and Neck Carcinoma. It is currently in Phase 3.

30

Indications

77

Total Trials

55

Active Trials

541

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Head and Neck CarcinomaActive, not recruiting

Gestational Trophoblastic NeoplasmActive, not recruiting

Colorectal CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

Rectal NeoplasmActive, not recruiting

Clear Cell AdenocarcinomaActive, not recruiting

Ovarian CarcinomaActive, not recruiting

Metastatic Malignant NeoplasmActive, not recruiting

Cervical CarcinomaActive, not recruiting

Neuroendocrine CarcinomaActive, not recruiting

Head and Neck CarcinomaPhase 2

Active, not recruiting

Gestational Trophoblastic NeoplasmPhase 2

Active, not recruiting

Colorectal CarcinomaPhase 2

Active, not recruiting

Lung CancerPhase 3

Active, not recruiting

Rectal NeoplasmPhase 2

Active, not recruiting

Clear Cell AdenocarcinomaPhase 1

Active, not recruiting

Ovarian CarcinomaPhase 3

Active, not recruiting

Metastatic Malignant NeoplasmPhase 1

Active, not recruiting

Cervical CarcinomaPhase 2

Active, not recruiting

Neuroendocrine CarcinomaPhase 2

Active, not recruiting

Showing 10 of 30 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Jemperli

GGlaxo Dba Glaxosmithkline

Tecentriq

Halaven

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Gemzar

GGynecologic Oncology Group

Megace

Bristol-Myers Squibb

MS Contin

Zolymbus

MS Contin

HHikma Pharmaceuticals LLC

Methylthioninium Chloride

PProvepharm SAS

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Primary Peritoneal Cancer

NCT04673448

Q4 2026

Phase 1/2Active, not recruiting

Pediatric

NCT06521567

Phase 3Active, not recruiting

Endometrial Cancer

NCT03981796

Phase 1Active, not recruiting

Advanced Solid Tumors

NCT04446351

Q1 2027

Post-ApprovalNot yet recruiting

Endometrial Cancer

NCT06897527

Phase 1Active, not recruiting

Advanced Solid Tumors

NCT02715284

Clinical

Trials by Indication[1]

Endometrial Cancer10 trials

DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer

Unknown status·GGrupo Español de Investigación en Cáncer de Ovario··NCT05728814·100 enrolled

A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)

Recruiting· GSK logo

GSK·Phase 2·NCT07108270·30 enrolled

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Active, not recruiting·AARCAGY/ GINECO GROUP·Phase 3·NCT05201547·260 enrolled

Show 7 more trials

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Active, not recruiting·TTesaro, Inc.·Phase 3·NCT03981796·785 enrolled

Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

Not yet recruiting·GGrupo Español de Investigación en Cáncer de Ovario·Phase 2·NCT07013851·25 enrolled

A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

Not yet recruiting· GSK logo

GSK·Phase 4·NCT06897527·100 enrolled

pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

Not yet recruiting·UUniversity College, London·Phase 2·NCT07115927·40 enrolled

A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

Active, not recruiting· GSK logo

GSK·Phase 2·NCT06317311·41 enrolled

Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05819892·21 enrolled

Adjuvant Checkpoint Blockade Plus Radiation In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04774419·62 enrolled

Advanced Solid Tumors5 trials

Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

Active, not recruiting·IiTeos Belgium SA·Phase 1/2·NCT05060432·153 enrolled

Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors

Completed·TTesaro, Inc.·Phase 1·NCT03250832·111 enrolled

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

Active, not recruiting·TTesaro, Inc.·Phase 1·NCT02715284·730 enrolled

Show 2 more trials

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

Active, not recruiting· GSK logo

GSK·Phase 1·NCT03843359·97 enrolled

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

Active, not recruiting· GSK logo

GSK·Phase 1·NCT04446351·107 enrolled

Ovarian Cancer4 trials

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

Terminated·TTesaro, Inc.·Phase 2·NCT03955471·41 enrolled

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Active, not recruiting·TTesaro, Inc.·Phase 3·NCT03602859·1,400 enrolled

Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer

Completed·TTesaro, Inc.·Phase 2·NCT05751629·41 enrolled

Show 1 more trial

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Unknown status·UUniversity Health Network, Toronto·Phase 2·NCT05065021·40 enrolled

Locally-advanced Rectal Cancer4 trials

PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients

Recruiting·—·Phase 3·NCT06762405·68 enrolled

Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

Recruiting·NNational Cancer Institute, Naples··NCT07269249·50 enrolled

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Active, not recruiting· GSK logo

GSK·Phase 2·NCT05723562·154 enrolled

Show 1 more trial

A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

Active, not recruiting· GSK logo

GSK·Phase 2·NCT06640049·23 enrolled

Non-Small Cell Lung Cancer4 trials

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3

Completed· GSK logo

GSK·Phase 2·NCT06926673·62 enrolled

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Recruiting· GSK logo

GSK·Phase 1/2·NCT06405230·40 enrolled

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

Completed· GSK logo

GSK·Phase 2·NCT03739710·175 enrolled

Show 1 more trial

Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Terminated· GSK logo

GSK·Phase 2·NCT04581824·243 enrolled

38 more indications

Head and Neck Squamous Cell Carcinoma3 trials

A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)

Not yet recruiting·UUniversity Health Network, Toronto·Phase 2·NCT07408063·30 enrolled

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Recruiting· GSK logo

GSK·Phase 3·NCT06256588·864 enrolled

Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Recruiting·GGrupo Español de Tratamiento de Tumores de Cabeza y Cuello·Phase 1/2·NCT05784012·34 enrolled

Colon Cancer3 trials

Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Recruiting·UUniversity of Iowa·Phase 2·NCT05239546·25 enrolled

Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT06830239·10 enrolled

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Recruiting· GSK logo

GSK·Phase 3·NCT05855200·892 enrolled

Lung Cancer3 trials

A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

Active, not recruiting·IiOnctura·Phase 1/2·NCT06879717·45 enrolled

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Active, not recruiting· GSK logo

GSK·Phase 2·NCT05565378·351 enrolled

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Active, not recruiting· GSK logo

GSK·Phase 3·NCT06472076·88 enrolled

Pancreatic Cancer3 trials

Niraparib + Dostarlimab + RT in Pancreatic Cancer

Completed·MMassachusetts General Hospital·Phase 2·NCT04409002·18 enrolled

DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer

Recruiting·HHopital Foch·Phase 2·NCT06757244·35 enrolled

Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

Completed·MMayo Clinic·Phase 2·NCT04493060·22 enrolled

Efficacy and Safety2 trials

Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

Terminated·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT04779151·51 enrolled

Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

Withdrawn·VVall d'Hebron Institute of Oncology·Phase 1/2·NCT06385548

Breast Cancer2 trials

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT04837209·32 enrolled

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Active, not recruiting·—·Phase 2·NCT04584255·62 enrolled

Metastatic2 trials

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

Active, not recruiting·UUniversity of Southern California·Phase 1·NCT04387084·10 enrolled

Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Active, not recruiting·TTrisha Wise-Draper·Phase 2·NCT04313504·23 enrolled

Primary Peritoneal Cancer2 trials

Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

Active, not recruiting·UUniversity of Washington·Phase 1·NCT04673448·18 enrolled

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 3·NCT04679064·427 enrolled

Melanoma1 trial

Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma

Active, not recruiting·DDiwakar Davar·Phase 2·NCT04139902·48 enrolled

Gastric Cancer1 trial

Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study

Recruiting·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT06059495·59 enrolled

Neuroendocrine Carcinoma1 trial

Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04701307·48 enrolled

Cervical Cancer1 trial

Dostarlimab and Cobolimab in Advanced Cervical Cancer

Active, not recruiting·MMeghan Shea·Phase 2·NCT06238635·66 enrolled

Penile Carcinoma1 trial

Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05526989·25 enrolled

Patients With Solid Tumors1 trial

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Terminated·EElevation Oncology·Phase 1·NCT05980416·88 enrolled

Progressive Cervix Cancer1 trial

Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Active, not recruiting·UUniversity of Oklahoma·Phase 2·NCT04068753·66 enrolled

Pediatric1 trial

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer

Active, not recruiting· GSK logo

GSK·Phase 1/2·NCT06521567·83 enrolled

Monotherapy1 trial

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM

Terminated· GSK logo

GSK·Phase 1/2·NCT06655818·4 enrolled

Cancers1 trial

PREventing Second Cancers With DOSTARlimab

Recruiting·CCentre Leon Berard·Phase 2·NCT05855811·400 enrolled

Locally Advanced Rectal Cancer (LARC)1 trial

XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients

Not yet recruiting·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 2·NCT07381777·270 enrolled

Colorectal Cancer1 trial

Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Withdrawn·IIbrahim Halil Sahin·Phase 2·NCT06365970

Serous Carcinoma1 trial

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Active, not recruiting·CCasey Cosgrove·Phase 2·NCT05870761·8 enrolled

Clear Cell Carcinoma1 trial

A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

Recruiting·YYonsei University·Phase 2·NCT06023862·198 enrolled

Cervical Carcinoma1 trial

Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma

Recruiting·—·Phase 2·NCT07336147·45 enrolled

Cholangiocarcinoma1 trial

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Withdrawn·—·Phase 2·NCT04895046

Brain Metastases1 trial

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05700721·120 enrolled

Solid Tumors1 trial

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)

Terminated· GSK logo

GSK·Phase 1·NCT04544995·47 enrolled

Selected Advanced Solid Tumors1 trial

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Completed· GSK logo

GSK·Phase 1·NCT02723955·829 enrolled

Metastatic Cancer1 trial

Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI

Recruiting·UUNICANCER·Phase 2·NCT06333314·120 enrolled

Microsatellite Stable1 trial

A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer

Recruiting· GSK logo

GSK·Phase 2·NCT06567782·120 enrolled

Treatment1 trial

Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

Withdrawn·AAGO Research GmbH·Phase 2·NCT05126342

Multiple Myeloma1 trial

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Active, not recruiting· GSK logo

GSK·Phase 2·NCT04126200·208 enrolled

Tumours, Gynecological1 trial

A Phase 1/2 Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Recruiting· GSK logo

GSK·Preclinical·NCT06796907·305 enrolled

Lung Cancer (Non-Small Cell)1 trial

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Active, not recruiting· GSK logo

GSK·Preclinical·NCT04655976·758 enrolled

Rectal Neoplasms1 trial

A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers.

Terminated·UUniversity of Iowa·Phase 1·NCT04926324·3 enrolled

Neoplasms1 trial

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Active, not recruiting· GSK logo

GSK·Phase 1·NCT05277051·152 enrolled

Neoplasms, Head and Neck1 trial

A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting· GSK logo

GSK·Phase 2·NCT06062420·316 enrolled

Ovarian Clear Cell Carcinoma1 trial

Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06065462·21 enrolled

Unspecified1 trial

Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Withdrawn·UUniversity of Miami·Phase 2·NCT05405192

Regulatory

FDA Approval Timeline[4]

Apr 22, 2021

JEMPERLI

BLA BLA761174

Sources

References

[1]
ClinicalTrials.gov — 77 trial records for Dostarlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dostarlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dostarlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761174). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: GGlaxo Dba Glaxosmithkline

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