Rybrevant

(Amivantamab)

Phase 3Monoclonal antibody

This medication is a type of immunotherapy that helps your body's immune system fight certain lung cancers by slowing or stopping the growth of cancer cells.[1] Rybrevant is currently being investigated across 12 indications[3], with its most advanced program in Phase 3.[1]

Rybrevant is one of 227 small molecule programs targeting Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

226

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung CancerRecruiting

Adenoid Cystic CarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Gastric CancerActive, not recruiting

CancerRecruiting

Advanced or Metastatic Non-Small Cell Lung CancerActive, not recruiting

ChemotherapyRecruiting

Solid Tumor, AdultActive, not recruiting

Lung Non-Small Cell CarcinomaRecruiting

Penile Squamous Cell CarcinomaNot yet recruiting

Lung CancerPhase 2

Recruiting

Adenoid Cystic CarcinomaPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Gastric CancerPhase 2

Active, not recruiting

CancerPhase 2

Recruiting

Advanced or Metastatic Non-Small Cell Lung CancerPhase 3

Active, not recruiting

ChemotherapyPhase 2

Recruiting

Solid Tumor, AdultPhase 1

Active, not recruiting

Lung Non-Small Cell CarcinomaPhase 2

Recruiting

Penile Squamous Cell CarcinomaPhase 2

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Rybrevant

Johnson & Johnson

Phase 3

5 2

Iza-Bren

Bristol-Myers Squibb

Phase 3

3 3

ABP 234

Amgen

Phase 3

3 4

Eftilagimod Alfa

IImmutep S.A.S.

Phase 3

1 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

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Solid Tumor, Adult

NCT06507306

Q2 2027

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05488314

Phase 3Active, not recruiting

Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05388669

Q3 2027

Phase 1Active, not recruiting

Primary

NCT06632236

Phase 2Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05663866

Q4 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer (NSCLC)

NCT05801029

Clinical

Trials by Indication[1]

Carcinoma, Non-Small-Cell Lung13 trials

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06120140·305 enrolled

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05908734·71 enrolled

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05488314·57 enrolled

Show 10 more trials

61186372NSC3001: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04538664·308 enrolled

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05663866·68 enrolled

A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT07586202·68 enrolled

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT07227025·60 enrolled

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06667076·480 enrolled

An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04077463·701 enrolled

A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05498428·520 enrolled

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04487080·1,074 enrolled

A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04988295·776 enrolled

61186372PANSC2003: 61186372PANSC2003 ISA#3 Platform Trial

Completed· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT06532032·12 enrolled

Non-Small Cell Lung Cancer5 trials

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

Active, not recruiting·EETOP IBCSG Partners Foundation·Phase 2·NCT05601973·60 enrolled

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04965090·43 enrolled

Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT04599712

Show 2 more trials

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02609776·751 enrolled

An Open-Label Phase I/II Study to Evaluate the Safety and prelimiBasnary Efficacy of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06083857·3 enrolled

Lung Cancer2 trials

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)

Recruiting·UUniversity Hospital, Essen·Phase 2·NCT06784791·20 enrolled

A Phase 1 / 2, Open Label, Study of Amivantamab (JNJ-61186372) Among Participants With Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination With Tyrosine Kinase Inhibitors

Active, not recruiting·UUniversity of Colorado, Denver·Preclinical·NCT05845671·12 enrolled

Colorectal Neoplasms2 trials

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06750094·700 enrolled

A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06662786·1,000 enrolled

Squamous Cell Carcinoma of Head and Neck2 trials

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07276399·600 enrolled

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT06385080·287 enrolled

17 more indications

Esophageal Cancer1 trial

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04945733·62 enrolled

Hepatocellular Carcinoma1 trial

A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05653427·18 enrolled

Cancer1 trial

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Recruiting·VVall d'Hebron Institute of Oncology·Phase 2·NCT03767075·1,000 enrolled

Gastric Cancer1 trial

A Study of Amivantamab in People With Esophagogastric Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05117931·25 enrolled

Chemotherapy1 trial

Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

Recruiting·FFondazione Ricerca Traslazionale·Phase 2·NCT07392658·33 enrolled

Adenoid Cystic Carcinoma1 trial

Amivantamab in Adenoid Cystic Carcinoma

Active, not recruiting·TTrisha Wise-Draper·Phase 2·NCT05074940·18 enrolled

Metastatic Colorectal Cancer1 trial

A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05379595·225 enrolled

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05388669·418 enrolled

Advanced Stage1 trial

A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT07107230·400 enrolled

Lung Non-Small Cell Carcinoma1 trial

A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT06116682·88 enrolled

Penile Squamous Cell Carcinoma1 trial

Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma Who Progressed to First-line Platinum-Based Chemotherapy: APOLO TRIAL (LACOG 2425)

Not yet recruiting·LLatin American Cooperative Oncology Group·Phase 2·NCT07808359·58 enrolled

Colorectal Cancer1 trial

Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study

Recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05845450·197 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase II, Open-label, Single-arm, Multi-centre Study to Evaluate the Safety and Efficacy of Osimertinib With Amivantamab as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (OSTARA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05801029·60 enrolled

Solid Tumor, Adult1 trial

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Active, not recruiting·KKumquat Biosciences Inc.·Phase 1·NCT06507306·92 enrolled

Non-small Cell Lung Cancers1 trial

A Single Arm, Phase 2 Study of Amivantamab, Lazertinib and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers (NSCLCs) With EGFR Mutations

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT05299125·54 enrolled

Primary1 trial

5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1·NCT06632236·12 enrolled

Leptomeningeal Metastasis1 trial

A Single-Arm Phase II Exploratory Clinical Study of Amivantamab Combined With Intrathecal Pemetrexed for Leptomeningeal Metastasis From EGFR-Mutated Lung Adenocarcinoma

Recruiting·SSecond Affiliated Hospital, Zhejiang University, School of Medicine·Preclinical·NCT07744529·15 enrolled

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Amivantamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amivantamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amivantamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Epidermal Growth Factor Receptor Erbb1 Inhibitor; Hepatocyte Growth Factor Receptor Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

Rybrevant

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Carcinoma, Non-Small-Cell Lung13 trials

Non-Small Cell Lung Cancer5 trials

Lung Cancer2 trials

Colorectal Neoplasms2 trials

Squamous Cell Carcinoma of Head and Neck2 trials

Esophageal Cancer1 trial

Hepatocellular Carcinoma1 trial

Cancer1 trial

Gastric Cancer1 trial

Chemotherapy1 trial

Adenoid Cystic Carcinoma1 trial

Metastatic Colorectal Cancer1 trial

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

Advanced Stage1 trial

Lung Non-Small Cell Carcinoma1 trial

Penile Squamous Cell Carcinoma1 trial

Colorectal Cancer1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Solid Tumor, Adult1 trial

Non-small Cell Lung Cancers1 trial

Primary1 trial

Leptomeningeal Metastasis1 trial

References

Drug Info

Quick Facts

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