spartalizumab

Phase 3Monoclonal antibody

spartalizumab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Antagonist.[2] It is being investigated across 18 indications, with its most advanced program in Phase 3.[1]

spartalizumab is one of 514 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

513

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

LymphomaActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

Cutaneous MelanomaActive, not recruiting

Neuroendocrine CarcinomaActive, not recruiting

Pancreatic Ductal AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

MyelofibrosisActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Gastric AdenocarcinomaPhase 2

Active, not recruiting

Cutaneous MelanomaPhase 2

Active, not recruiting

Neuroendocrine CarcinomaPhase 2

Active, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 1

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

MyelofibrosisPhase 1

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

spartalizumab

Novartis

Phase 3

1 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

DATROWAY

Daiichi Sankyo

Preclinical

4 4

Voltaren

Novartis

Preclinical

1 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Tricor

JJagotec

Preclinical

1 8

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 9

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 10

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Multiple Cancer

NCT04802876

Q1 2028

Phase 2Active, not recruiting

Treatment

NCT05201066

Clinical

Trials by Indication[1]

Melanoma2 trials

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04310397·4 enrolled

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Terminated· Novartis logo

Novartis·Phase 3·NCT02967692·568 enrolled

HNSCC1 trial

Ribociclib and Spartalizumab in R/M HNSCC

Unknown status·NNational Taiwan University Hospital·Phase 1·NCT04213404·13 enrolled

Malignancies1 trial

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Terminated· Novartis logo

Novartis·Phase 1·NCT04000529·122 enrolled

ART1 trial

A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

Terminated· Novartis logo

Novartis·Phase 1·NCT04261439·60 enrolled

Advanced1 trial

Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

Completed· Novartis logo

Novartis·Phase 1/2·NCT02795429·89 enrolled

13 more indications

Gastric Adenocarcinoma1 trial

Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05135845·90 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Terminated· Novartis logo

Novartis·Phase 2·NCT04390763·164 enrolled

Multiple Cancer1 trial

Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors

Active, not recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT04802876·184 enrolled

Nasopharyngeal Carcinoma1 trial

Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Completed· Novartis logo

Novartis·Phase 2·NCT02605967·122 enrolled

Pancreatic Cancer1 trial

Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer

Completed·EEmory University·Phase 1/2·NCT04191421·35 enrolled

Breast Cancer1 trial

Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Terminated· Novartis logo

Novartis·Phase 1·NCT03742349·64 enrolled

Renal Cell Carcinoma1 trial

A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

Active, not recruiting·—·Phase 1·NCT04028245·17 enrolled

Colorectal Cancer1 trial

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Terminated· Novartis logo

Novartis·Phase 1·NCT04294160·122 enrolled

Treatment1 trial

Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05201066·33 enrolled

Myelofibrosis1 trial

Study of Select Combinations in Adults With Myelofibrosis

Withdrawn· Novartis logo

Novartis·Phase 1·NCT04283526

MET Exon 14 Skipping Mutation1 trial

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

Terminated· Novartis logo

Novartis·Phase 2·NCT04323436·31 enrolled

Non-Small Cell Lung Cancer1 trial

Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03647488·18 enrolled

Metastatic Colorectal Cancer1 trial

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT03081494·10 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for spartalizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — spartalizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for spartalizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis 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: Novartis

spartalizumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Trials by Indication[1]

Melanoma2 trials

HNSCC1 trial

Malignancies1 trial

ART1 trial

Advanced1 trial

Gastric Adenocarcinoma1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Multiple Cancer1 trial

Nasopharyngeal Carcinoma1 trial

Pancreatic Cancer1 trial

Breast Cancer1 trial

Renal Cell Carcinoma1 trial

Colorectal Cancer1 trial

Treatment1 trial

Myelofibrosis1 trial

MET Exon 14 Skipping Mutation1 trial

Non-Small Cell Lung Cancer1 trial

Metastatic Colorectal Cancer1 trial

References

Drug Info

Quick Facts

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