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Savolitinib

Phase 3Small molecule

Savolitinib is used to treat a type of kidney cancer called renal cell carcinoma, specifically in patients whose tumors have a certain genetic mutation (MET exon 14 skipping).[1] Savolitinib is currently being investigated across 13 indications[3], with its most advanced program in Phase 3.[1]

Savolitinib is one of 271 small molecule programs targeting Lung Cancer. It is currently in Phase 3.

13

Indications

31

Total Trials

18

Active Trials

270

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerCompleted

Prostate CancerActive, not recruiting

Gastric CancerRecruiting

NSCLCRecruiting

TreatmentNot yet recruiting

Carcinoma, Renal CellActive, not recruiting

Recurrent Diffuse Intrinsic Pontine GliomaActive, not recruiting

Non-Small-Cell LungActive, not recruiting

Lung CancerPhase 2

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Completed

Prostate CancerPhase 2

Active, not recruiting

Gastric CancerPhase 2

Recruiting

NSCLCPhase 2

Recruiting

TreatmentPhase 2

Not yet recruiting

Carcinoma, Renal CellPhase 3

Active, not recruiting

Recurrent Diffuse Intrinsic Pontine GliomaPhase 1

Active, not recruiting

Non-Small-Cell LungPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Savolitinib

Second-Line Systemic Therapy

SSun Yat-sen University

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

PD-1 Inhibitors

BBioNTech US Inc.

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Non-Small-Cell Lung

NCT05261399

Phase 2Active, not recruiting

Adenocarcinoma

NCT04923932

Phase 3Active, not recruiting

Carcinoma, Renal Cell

NCT03091192

Q1 2027

Phase 2Active, not recruiting

Lung Cancer

NCT05374603

Phase 3Active, not recruiting

Papillary Renal Cell Carcinoma

NCT05043090

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT04606771

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

Completed·HHutchison Medipharma Limited·Phase 3·NCT04923945·203 enrolled

Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance

Active, not recruiting·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT03833440·114 enrolled

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib + Osimertinib Versus Placebo + Osimertinib as the First Line Therapy for Patients With EGFRm+/MET+ NSCLC

Active, not recruiting·HHutchison Medipharma Limited·Phase 3·NCT05009836·412 enrolled

Show 1 more trial

A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination With Osimertinib vs Savolitinib in Combination With Placebo in Patients With EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04606771·30 enrolled

Tics2 trials

A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04118842·40 enrolled

A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04179071·16 enrolled

Lung Cancer2 trials

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

Savolitinib Combine With Durvalumab in Chinese EGFR Wild-type Locally Advanced or Metastatic NSCLC Patients With MET Alteration: An Open-label, Interventional, Multiple-center, Exploratory Trial (SOUND)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05374603·47 enrolled

Adenocarcinoma1 trial

Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Active, not recruiting·HHutchison Medipharma Limited·Phase 2·NCT04923932·75 enrolled

Metformin1 trial

A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05768360·6 enrolled

21 more indications

Treatment1 trial

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

Prostate Cancer1 trial

Prostate Cancer Biomarker Enrichment and Treatment Selection

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03385655·200 enrolled

Kidney Cancer1 trial

Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02761057·152 enrolled

Metastatic NSCLC1 trial

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

Completed·UUNICANCER·Phase 2·NCT02117167·999 enrolled

Osimertinib1 trial

Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC

Active, not recruiting·GGuangdong Association of Clinical Trials·Phase 2·NCT05163249·44 enrolled

Gastric Cancer1 trial

Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2)

Recruiting·JJeeyun Lee·Phase 2·NCT05620628·25 enrolled

Lung Sarcomatoid Carcinoma1 trial

A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

Unknown status·HHutchison Medipharma Limited·Phase 2·NCT02897479·76 enrolled

NSCLC1 trial

Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression

Recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 1/2·NCT05777278·29 enrolled

Drug1 trial

A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04121910·16 enrolled

Renal Cell Carcinoma1 trial

MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

Completed·QQueen Mary University of London·Phase 2·NCT02819596·69 enrolled

Colorectal Cancer1 trial

Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT03592641·5 enrolled

Midazolam1 trial

A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04187456·14 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

ESS1 trial

A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05888207·16 enrolled

Positron-Emission Tomography1 trial

A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06348355·7 enrolled

Papillary Renal Cell Carcinoma1 trial

A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05043090·148 enrolled

Non-Small-Cell Lung1 trial

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05261399·341 enrolled

Recurrent Diffuse Intrinsic Pontine Glioma1 trial

A Phase I Study of Savolitinib in Recurrent, Progressive, or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS Tumors Harboring MET Aberrations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03598244·41 enrolled

Carcinoma, Renal Cell1 trial

A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT03091192·60 enrolled

Colorectal Cancer (CRC)1 trial

Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study

Not yet recruiting·FFudan University·Preclinical·NCT07683403·138 enrolled

Unspecified1 trial

A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib (The SAVANNAH Study)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03778229·367 enrolled

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Savolitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Savolitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Savolitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Hepatocyte Growth Factor Receptor Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

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