Rilvegostomig

Phase 3Small molecule

Rilvegostomig is one of 284 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

283

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Esophageal AdenocarcinomaActive, not recruiting

Biliary Tract CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

MelanomaRecruiting

Hepatocellular CarcinomaActive, not recruiting

Gastric CancerRecruiting

Head and Neck Squamous Cell CarcinomaCompleted

Endometrial CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Esophageal AdenocarcinomaPhase 2

Active, not recruiting

Biliary Tract CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

MelanomaPreclinical

Recruiting

Hepatocellular CarcinomaPhase 3

Active, not recruiting

Gastric CancerPhase 3

Recruiting

Head and Neck Squamous Cell CarcinomaPhase 1

Completed

Endometrial CancerPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Rilvegostomig

AstraZeneca

Phase 3

5 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

PORTRAZZA

Eli Lilly

Preclinical

8 5

Lenvima

Eisai

Preclinical

6 6

Imjudo

AstraZeneca

Preclinical

5 7

Vizimpro

Pfizer

Preclinical

4 8

Gilotrif

Boehringer Ingelheim

Preclinical

12 9

Ofev

Boehringer Ingelheim

Preclinical

7 10

Immunotherapy

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Gastric Cancer

NCT04379596

Phase 1Recruiting

Non-Squamous NSCLC

NCT04686305

Phase 3Active, not recruiting

Adenocarcinoma

NCT06564844

Q4 2027

Phase 2Recruiting

Advanced Solid Tumours

NCT05489211

Phase 2Active, not recruiting

Hepatocellular Carcinoma

NCT05775159

Q3 2028

Phase 2Recruiting

Gastroesophageal Adenocarcinoma

NCT07069712

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06692738·880 enrolled

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06868277·830 enrolled

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT06996782·152 enrolled

Show 2 more trials

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07098338·278 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

Gastric Cancer3 trials

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06764875·840 enrolled

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)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04379596·450 enrolled

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07431281·2,130 enrolled

Biliary Tract Cancer3 trials

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07221253·1,100 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06109779·760 enrolled

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06467357·620 enrolled

Hepatocellular Carcinoma2 trials

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06921785·1,220 enrolled

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

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

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

Adenocarcinoma1 trial

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06564844·24 enrolled

Advanced Solid Tumours1 trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

Genomic Alterations1 trial

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06357533·675 enrolled

Gastroesophageal Adenocarcinoma1 trial

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07069712·100 enrolled

Melanoma1 trial

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT07115043·60 enrolled

Stomach Neoplasms1 trial

A Phase II Platform Trial of Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer (Neo-VIKTORY)

Recruiting·JJeeyun Lee·Phase 2·NCT06630130·100 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06627647·878 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

Endometrial Cancer1 trial

DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06989112·600 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Rilvegostomig. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rilvegostomig compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rilvegostomig. 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

Rilvegostomig

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Gastric Cancer3 trials

Biliary Tract Cancer3 trials

Hepatocellular Carcinoma2 trials

Cancer1 trial

Non-squamous NSCLC1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Adenocarcinoma1 trial

Advanced Solid Tumours1 trial

Genomic Alterations1 trial

Gastroesophageal Adenocarcinoma1 trial

Melanoma1 trial

Stomach Neoplasms1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Endometrial Cancer1 trial

References

Drug Info

Quick Facts

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