Volrustomig

Phase 3Small molecule

Volrustomig is one of 309 small molecule programs targeting Locally Advanced Head and Neck Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

308

Competitors

Pipeline

Status by Indication[3][1]

Indication

Locally Advanced Head and Neck Squamous Cell CarcinomaRecruiting

Locally Advanced Cervical CancerRecruiting

Hepatocellular CarcinomaActive, not recruiting

Metastatic Colorectal CancerRecruiting

Metastatic Non Small Cell Lung CancerActive, not recruiting

Advanced Clear Cell Renal Cell CarcinomaActive, not recruiting

Endometrial CancerRecruiting

Head and Neck CancerRecruiting

CancerRecruiting

Gastroesophageal Junction AdenocarcinomaRecruiting

Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3

Recruiting

Locally Advanced Cervical CancerPhase 3

Recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Recruiting

Metastatic Non Small Cell Lung CancerPhase 3

Active, not recruiting

Advanced Clear Cell Renal Cell CarcinomaPhase 1

Active, not recruiting

Endometrial CancerPhase 2

Recruiting

Head and Neck CancerPhase 2

Recruiting

CancerPhase 1

Recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Arimidex

IIstituto Clinico Humanitas

Phase 3

3 2

Zimberelimab

Arcus Biosciences

Phase 3

4 3

Volrustomig

AstraZeneca

Phase 3

2 4

Neoadjuvant Therapy

SSun Yat-sen University

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

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

Treatment

1 10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Advanced Clear Cell Renal Cell Carcinoma

NCT07000149

Q2 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT04379596

Phase 1Recruiting

Non-Squamous NSCLC

NCT04686305

Q3 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT06448754

Q4 2027

Phase 2Recruiting

Endometrial Cancer

NCT05489211

Phase 2Active, not recruiting

Hepatocellular Carcinoma

NCT05775159

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06448754·194 enrolled

A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05061550·630 enrolled

Locally Advanced Cervical Cancer2 trials

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06079671·800 enrolled

A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06943833·37 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05702229·163 enrolled

Head and Neck Cancer1 trial

Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer

Recruiting·UUniversity of Chicago·Phase 2·NCT07065630·38 enrolled

Cancer1 trial

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Recruiting·PPresage Biosciences·Phase 1·NCT04541108·15 enrolled

11 more indications

Non-squamous NSCLC1 trial

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04686305·244 enrolled

Cervical Carcinoma1 trial

A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06535607·257 enrolled

Locally Advanced Head and Neck Squamous Cell Carcinoma1 trial

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06129864·1,145 enrolled

Gastric Cancer1 trial

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04379596·452 enrolled

Hepatocellular Carcinoma1 trial

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05775159·294 enrolled

Metastatic Colorectal Cancer1 trial

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06792695·80 enrolled

Endometrial Cancer1 trial

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

Advanced Clear Cell Renal Cell Carcinoma1 trial

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT07000149·9 enrolled

Metastatic Non Small Cell Lung Cancer1 trial

A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05984277·895 enrolled

Pleural Mesothelioma1 trial

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06097728·863 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592

Completed·PPresage Biosciences·Phase 1·NCT06366451·17 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Volrustomig. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Volrustomig compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Volrustomig. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Volrustomig

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Locally Advanced Cervical Cancer2 trials

Gastroesophageal Junction Adenocarcinoma1 trial

Head and Neck Cancer1 trial

Cancer1 trial

Non-squamous NSCLC1 trial

Cervical Carcinoma1 trial

Locally Advanced Head and Neck Squamous Cell Carcinoma1 trial

Gastric Cancer1 trial

Hepatocellular Carcinoma1 trial

Metastatic Colorectal Cancer1 trial

Endometrial Cancer1 trial

Advanced Clear Cell Renal Cell Carcinoma1 trial

Metastatic Non Small Cell Lung Cancer1 trial

Pleural Mesothelioma1 trial

Head and Neck Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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