RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea)

Structure/Sequence

Sequence Code 143885L

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Sequence Code 13387733H

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Sequence Code 13387743H

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Sequence Code 13387747L

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Clinical Trials associated with Amivantamab-VMJM

JPRN-jRCT1031260351

/ RecruitingPhase 3IIT

JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)

Start Date30 Jul 2026

Sponsor / Collaborator-

NCT07586202

/ RecruitingPhase 2

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

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

Start Date28 Jul 2026

Sponsor / Collaborator

Janssen Research & Development LLC

NCT07744529

/ RecruitingPhase 1/2IIT

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

The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid.
The main questions this study aims to answer are:
What medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?
Participants will:
Receive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.
Continue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.
Have cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.
Have tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.
Have imaging tests, including enhanced MRI, about every 3 months to check the disease.
Be followed by clinic visits and/or telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.

Start Date28 May 2026

Sponsor / Collaborator-

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

312

Literatures (Medical) associated with Amivantamab-VMJM

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer

Article

Author: Upton, Elysia ; Hearmon, Natalie ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh

OBJECTIVES:

Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.

METHODS:

A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.

RESULTS:

The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.

LIMITATIONS:

Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.

CONCLUSIONS:

From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.

01 Sep 2026·ORAL ONCOLOGY

Intravenous amivantamab after cetuximab failure in recurrent or metastatic head and neck squamous cell carcinoma: a single-centre retrospective real-world cohort study

Article

Author: Lin, Fengjuan ; Xue, Liqiong ; Guo, Ye ; Zhao, Wei ; Tang, Wenbo ; Zhou, Jiuli

BACKGROUND:

Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who exhaust platinum, immune checkpoint inhibitors (ICIs), and cetuximab lack standard options. The OrigAMI-4 trial showed subcutaneous amivantamab activity in anti-EGFR-naïve patients; real-world intravenous (IV) amivantamab data after cetuximab failure are absent.

METHODS:

We retrospectively analysed consecutive R/M HNSCC patients treated with IV amivantamab monotherapy (November 2024-July 2025) after progression on standard therapies. Response was assessed per RECIST 1.1; toxicity per CTCAE v5.0.

RESULTS:

Twenty patients were included (median age 54 years; 70.0% male; median four prior systemic lines). All received prior platinum and ICIs; 18 (90.0%) progressed on cetuximab. At a median follow-up of 6.8 months, confirmed ORR was 30.0% (6/20; 95% CI 11.9-54.3) ; DCR at first reassessment (6 weeks) was 80.0% (16/20; 95% CI 56.3-94.3) and confirmed DCR at 12 weeks was 45.0% (9/20; 95% CI 23.1-68.5). Median PFS was 3.0 months (95% CI 2.3 to not reached) and median OS 9.7 months (95% CI 6.8 to not reached). The most frequent treatment-related adverse events were hypoalbuminaemia (90.0%), rash (70.0%), and infusion-related reactions (45.0%; all grade 1-2); two patients had grade 3 events, none discontinued treatment.

CONCLUSION:

In this small retrospective cohort, IV amivantamab showed antitumour activity in heavily pretreated, cetuximab-exposed R/M HNSCC, with a 30% confirmed ORR, 45% confirmed 12-week DCR, 9.7-month median OS, and no treatment discontinuations for toxicity. These data suggest that dual EGFR-MET targeting may retain clinical utility after anti-EGFR failure, and support prospective evaluation with biomarker stratification.

01 Sep 2026·EUROPEAN JOURNAL OF CANCER

Assessing time to symptomatic progression, a patient-relevant efficacy endpoint, in the MARIPOSA study in non-small cell lung cancer

Article

Author: Ord, Priya ; Ennis, Mariah ; Lu, Shun ; Felip, Enriqueta ; Gadgeel, Shirish M ; Nguyen, Danny ; Bauml, Joshua M ; Frosien, Markus ; Montes, Lizbett Vanessa García ; Akamatsu, Hiroaki ; Forster, Martin D ; Lin, Chien-Chung ; Charoentum, Chaiyut ; Lee, Se-Hoon ; Schuette, Wolfgang ; Kerßenboom, Ronja ; Cho, Byoung Chul ; Meißner, Janka ; Kowalyszyn, Ruben ; Misch, Daniel ; Urban, Damien ; Fennema, Elizabeth ; Arslan, Cagatay ; Cruz-Correa, Marcia ; Aguilar, Andres ; Daksh, Mahesh ; Girard, Nicolas ; Sethi, Seema ; Owen, Scott ; Cruz, Felipe Melo ; Sermon, Jan

INTRODUCTION:

In the phase 3 randomized MARIPOSA study, amivantamab and lazertinib combination therapy demonstrated improved progression-free survival (PFS) and overall survival (OS) versus osimertinib in participants with previously untreated, epidermal growth factor receptor-mutated advanced non-small cell lung cancer. Time to symptomatic progression (TTSP) was introduced to assess clinical worsening and complement endpoints that investigate radiographic disease progression and patient-reported outcomes. TTSP provides an easily interpretable measure of disease-specific symptom worsening to further support patient experience.

METHODS:

In MARIPOSA, TTSP was quantitatively assessed as a secondary efficacy endpoint and defined as the time from randomization until participants experience disease-specific symptom worsening requiring a clinical intervention or treatment change, or death. To evaluate the impact of amivantamab and lazertinib on TTSP considering its established OS benefit against osimertinib, an exploratory analysis censoring death events was performed.

RESULTS:

At the final protocol-specified OS analysis (median follow up: 37.8 months), median TTSP was 43.6 months with amivantamab and lazertinib versus 29.3 months with osimertinib (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.57-0.83; p < 0.0001). Amivantamab and lazertinib reduced deaths following a TTSP event compared to osimertinib. A strong correlation between TTSP and PFS or OS was observed.

CONCLUSIONS:

Amivantamab and lazertinib significantly delayed TTSP versus osimertinib. TTSP offers a clinician-validated measurement of disease-specific symptom worsening, capturing symptoms perceived by patients that prompt clinical action. TTSP is highly correlated with PFS and OS, providing complementary insights alongside traditional endpoints. TTSP enhances understanding of treatment benefit and supports informed clinical decision-making by integrating patient experience.

380

News (Medical) associated with Amivantamab-VMJM

25 Aug 2026

·allsci.com

Ivonescimab Phase III PFS benefit gets peer-reviewed backing ahead of FDA decision

Peer-reviewed results from the global Phase III HARMONi trial have confirmed a significant PFS benefit for ivonescimab in EGFR-mutated NSCLC, but the study's primary overall survival (OS) analysis remained non-significant ahead of a US FDA decision due November 14, 2026. The primary analysis of the trial data was published in The Lancet Oncology, while Summit Therapeutics Inc.'s (Nasdaq: SMMT) press release plans to present updated OS data at the World Conference on Lung Cancer (WCLC 2026) on September 15, 2026. HARMONi is a randomized, double-blind, placebo-controlled Phase III trial enrolling patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after a third-generation EGFR tyrosine kinase inhibitor (TKI). The study ran across 114 centers in Asia, Europe, and North America. At the primary analysis, ivonescimab plus platinum-doublet chemotherapy produced a median progression-free survival (PFS) of 6.8 months versus 4.4 months with placebo plus chemotherapy, a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.0001) assessed by independent radiographic review. The PFS benefit was consistent across preplanned subgroups. At the time of the primary OS analysis, the combination showed a positive OS trend that did not reach statistical significance. Treatment-related grade 3–5 hemorrhage events occurred in fewer than 1% of patients in the ivonescimab arm, consistent with prior clinical experience, Summit said. Ivonescimab simultaneously blocks PD-1 and vascular endothelial growth factor (VEGF) through a single tetravalent bispecific antibody engineered by China-based Akeso Inc. (HKEX: 9926.HK). The molecule is designed to preferentially accumulate in the tumor microenvironment, where both PD-1 and VEGF are more highly expressed than in normal tissue. Summit holds commercialization rights in North America, South America, Europe, the Middle East, Africa, and Japan; Akeso retains rights elsewhere, including China, where ivonescimab was first approved in May 2024 for EGFR-TKI-resistant non-squamous NSCLC. The post-third-generation TKI setting has historically resisted immunotherapy. Prior Phase III studies of PD-1 monoclonal antibodies failed to show PFS or OS benefit in this population, making HARMONi's statistically significant PFS result the first for an immunotherapy-based regimen in a global trial of this kind, Summit said. An updated OS analysis based on a June 2026 data cut showed a continued positive OS trend, with western patients achieving an OS hazard ratio of 0.76, consistent with the overall study population. That data will be presented at WCLC 2026. The HARMONi-A study — a single-region China-based predecessor trial in a similar population — demonstrated a statistically significant OS benefit (HR 0.74; p=0.019), providing supportive context for the global dataset. Summit proceeded with its BLA submission based on the PFS result and the positive OS trend, citing the absence of any FDA-approved regimen with demonstrated OS benefit in this patient population and the consistency of results between Asian and western cohorts. The PDUFA goal action date is November 14, 2026. In the US, Johnson & Johnson's EGFR/MET-targeted bispecific antibody Rybrevant (amivantamab-vmjw) is approved with carboplatin and pemetrexed for patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations whose disease has progressed on or after an EGFR TKI. That molecule's September 2024 approval was based on the Phase III MARIPOSA-2 trial, in which the regimen produced a median PFS of 6.3 months versus 4.2 months with chemotherapy alone (HR 0.48; 95% CI: 0.36–0.64). Ivonescimab combines PD-1 and VEGF blockade, potentially providing a mechanistically distinct treatment option if approved. Cross-trial comparisons between HARMONi and MARIPOSA-2 remain limited by differences in eligibility criteria, comparator arms, and study design. Summit's global Phase III program for ivonescimab now spans five company-sponsored studies, including HARMONi-3 (first-line NSCLC versus Merck's Keytruda (pembrolizumab) plus chemotherapy), HARMONi-7 (first-line high PD-L1 NSCLC monotherapy versus pembrolizumab), HARMONi-GI3 (first-line metastatic colorectal cancer), and HARMONi-GU1 (first-line urothelial carcinoma). Akeso separately received NMPA approval in August 2026 for ivonescimab plus chemotherapy in first-line squamous NSCLC based on HARMONi-6 OS data — the third approved indication for the molecule in China. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Phase 3Clinical ResultDrug ApprovalImmunotherapy

25 Aug 2026

·www.biospace.com

Parabilis Medicines Appoints Accomplished Drug Development Leader Craig L. Tendler, M.D., to Board of Directors

CAMBRIDGE, Mass., Aug. 25, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced the appointment of Craig L. Tendler, M.D., to its Board of Directors. Dr. Tendler previously led both clinical development and medical affairs for oncology at Johnson & Johnson. He has served as a scientific advisor to Parabilis Medicines, a role he will continue alongside his Board responsibilities. “We are delighted to welcome Craig to the Parabilis Board of Directors,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “I have known Craig for many years and know the rigor, judgment and creativity he brings. His unparalleled experience guiding innovative medicines from clinical development and global approval through subsequent product adoption and medical affairs will be tremendously valuable to Parabilis as we continue to advance zolucatetide across multiple indications and build our broader pipeline of Helicon TM therapeutics. I consider Craig to be one of the most prolific oncology drug developers in our industry. He has a strategic mind and is driven by patient needs in all that he does.” “Throughout my career, I have seen the difference that opening new therapeutic avenues can make for patients,” said Dr. Tendler. “I am pleased to join the Board of Parabilis at this pivotal time and complement its efforts to translate clinical insights into strategies that accelerate the development and approval of potentially transformational therapies such as zolucatetide.” Dr. Tendler brings more than 30 years of experience in oncology drug development and medical affairs, including two decades at Johnson & Johnson, where he held leadership roles across clinical development, medical affairs and business development and most recently served as Global Head of Late-Stage Clinical Development and Global Medical Affairs for Oncology. During his tenure at J&J, he played a key role in securing more than 30 oncology regulatory approvals across prostate cancer (ZYTIGA®, AKEEGA® and ERLEADA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®), lung cancer (RYBREVANT®) and bladder cancer (BALVERSA®), as well as 13 FDA Breakthrough Therapy designations and approvals for 15 New Molecular Entities (NMEs). He also worked closely with clinical and commercial teams to support the practical adoption of many of these practice-changing medicines through medical affairs data generation activities in collaboration with academic and community-based investigators. Dr. Tendler also played an integral role in securing major oncology business development transactions and collaborations, including J&J’s acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals and Taris Biomedical and co-development partnerships with Legend Biotech, Pharmacyclics and Genmab. Before joining J&J, Dr. Tendler spent nearly a decade at the Schering-Plough Research Institute, where he held positions of increasing responsibility in oncology clinical research. Earlier in his career, he served as an Assistant Professor of Pediatrics and Pediatric Hematology/Oncology at the Mount Sinai School of Medicine and was an NIH physician-scientist grant recipient and research fellow at the National Cancer Institute. He continues to serve as an Adjunct Assistant Professor of Pediatrics at Mount Sinai. Dr. Tendler currently serves on the Board of Directors of TuHURA Biosciences and Predicta Biosciences and as a scientific advisor for several biotechnology companies. He is also an alternate industry representative to the FDA’s Oncologic Drugs Advisory Committee. He earned his M.D. with high honors from Mount Sinai. About Parabilis Medicines Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and a range of other rare and common solid tumor indications. Beyond zolucatetide, Parabilis is pursuing a follow-on β-catenin degrader program and advancing additional Helicon-based programs focused on other challenging targets, including ERG and allosteric AR ON in prostate cancer, where we believe our medicines could have life-altering impact. For more information, visit or follow us on LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements relating to the expected contributions and impact of Dr. Tendler’s contributions to the Company; and other statements regarding the Company’s future plans, objectives, and financial and operational performance. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that could negatively affect the Company’s business, operating results, financial condition and stock value. Factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release include, without limitation: risks relating to the Company’s research and development activities; the Company’s ability to execute on its strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; the Company’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining the Company’s intellectual property protections; and risks related to the competitive landscape for the Company’s product candidates; as well as other risks and uncertainties described in greater detail in “Risk Factors,” in the Company’s most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Media Contact: Jessica Freifeld media@parabilismed.com Investor Contact: Tom Kotarakos investors@parabilismed.com

Executive ChangeBreakthrough Therapy

17 Aug 2026

·allsci.com

Tagrisso plus Orpathys extends OS in MET-resistant EGFR-mutated lung cancer

The SAFFRON Phase III trial has shown that an oral targeted combination can improve both progression-free and overall survival in patients with EGFR-mutant non-small cell lung cancer (NSCLC) and MET-driven resistance to osimertinib, according to AstraZeneca (LSE/STO/NYSE: AZN). The result could establish a new biomarker-directed treatment option for patients who progress on Tagrisso (osimertinib). The global trial tested savolitinib (Orpathys), a selective MET tyrosine kinase inhibitor (TKI) co-developed by AstraZeneca and HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13), in combination with osimertinib against platinum-based doublet chemotherapy. SAFFRON enrolled 345 patients with EGFR-mutant locally advanced or metastatic NSCLC with high MET overexpression or amplification whose disease had progressed on first- or second-line osimertinib. The combination met the primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS), producing statistically significant and clinically meaningful improvements over chemotherapy, the companies said. No hazard ratios or median PFS or OS figures were disclosed in the top-line announcement, with full results due at a forthcoming medical meeting. The safety profile was consistent with the established profiles of the two drugs, with no new safety findings reported. MET amplification and overexpression are important mechanisms of acquired resistance to EGFR TKIs. Savolitinib inhibits aberrant MET signaling while continued osimertinib treatment maintains EGFR suppression, allowing the combination to target both the original oncogenic driver and a major pathway through which tumors can escape EGFR inhibition. AstraZeneca estimates that high-level MET overexpression or amplification occurs in approximately 34% of tumors following progression on third-generation EGFR TKIs. Osimertinib is already widely approved across EGFR-mutant NSCLC, while the savolitinib-osimertinib combination is approved in China for patients with MET-amplified disease following EGFR-TKI treatment. That approval was supported by the SACHI Phase III trial, which reported median investigator-assessed PFS of 8.2 months with the combination versus 4.5 months with chemotherapy. The combination has also received temporary authorization in Switzerland based on Phase II SAVANNAH data. SAFFRON now provides global Phase III evidence that could support regulatory filings in the US, EU, and other markets. Competition in the post-osimertinib setting includes Johnson & Johnson's Rybrevant (amivantamab-vmjw), an EGFR-MET bispecific antibody approved by the US FDA in September 2024 with carboplatin and pemetrexed following EGFR-TKI progression. Unlike SAFFRON, that indication covers the broader post-EGFR-TKI population and does not require selection for MET-driven resistance. AstraZeneca and Daiichi Sankyo's TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan) is also approved for EGFR-mutant NSCLC following prior EGFR-directed therapy and platinum-based chemotherapy. Savolitinib plus osimertinib could therefore become the first globally available all-oral, biomarker-directed regimen specifically for MET-driven resistance following osimertinib. The Phase III OS benefit is particularly important in a setting where treatment development has increasingly focused on overcoming molecular mechanisms of acquired resistance rather than moving patients directly to non-selective chemotherapy. AstraZeneca and HUTCHMED plan to submit the SAFFRON results to regulatory authorities globally, with detailed findings to be presented at a forthcoming medical meeting. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Phase 3Drug ApprovalClinical ResultADC

100 Deals associated with Amivantamab-VMJM

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amivantamab-VMJM	L01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive non-small cell lung cancer	Japan	Janssen Pharmaceutical KK	27 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
Non-Small Cell Lung Cancer	Canada	Janssen, Inc.	30 Mar 2022
EGFR ex20ins mutation in non-small cell lung cancer	United States	Janssen Biotech, Inc.	21 May 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Cilag AG	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Shanghai Johnson & Johnson Pharmaceutical Ltd.	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Janssen-Cilag International NV	26 Jan 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	China	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Japan	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Australia	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Austria	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Belgium	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Brazil	Janssen Research & Development LLC	03 Dec 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_Breakthrough2026	Not Applicable	Non-Small Cell Lung Cancer EGFR-mutant	302	Amivantamab plus carboplatin-pemetrexed (EGFR-mutant NSCLC)	vziewuftwv(rekpsblqiz) = ftbqlzxwjh upxhvkzrpn (fdzsndquef ) View more	Positive	25 Jun 2026
				Carboplatin-pemetrexed (EGFR-mutant NSCLC)	vziewuftwv(rekpsblqiz) = ltxrduxyvo upxhvkzrpn (fdzsndquef ) View more
NCT05379595 (OrigAMI-1, Pubmed \| J Clin Oncol)	Phase 1/2	RAS/BRAF Wild Type Colorectal Cancer Third line RAS / BRAF / EGFR ectodomain wild-type \| ERBB2/HER2 amplification	94	Amivantamab (cohort A)	npcwsjekcz(fzrvbfbxzb) = ujnucgyanx jxuuxrzutu (qmlkosvqbx ) View more	Positive	10 Jun 2026
				Amivantamab (cohort B)	npcwsjekcz(fzrvbfbxzb) = qiyroyxzui jxuuxrzutu (qmlkosvqbx ) View more
NCT05379595 (OrigAMI‑1, ASCO2026)	Phase 1/2	RAS/BRAF Wild Type Colorectal Cancer RAS/BRAF wild-type	73	Amivantamab (CMS2)	ujkqpyogwp(nanznsjlof) = tqjklgomzo spyuorbgag (wjkwayqixu ) View more	Positive	29 May 2026
				Amivantamab (CMS4)	ujkqpyogwp(nanznsjlof) = stsntqqafv spyuorbgag (wjkwayqixu ) View more
NCT04077463 (CHRYSALIS-2, ASCO2026)	Phase 1	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutations	49	Amivantamab plus lazertinib	yiibwcukid(copobjphcq) = azprfnlrmf wgztoddjyy (kqscerrdgf, 27.7 - NE) View more	Positive	29 May 2026
ASCO2026	Not Applicable	-	15	oral doxycyclinetopical clindamycinl corticosteroids + oral doxycyclinetopical clindamycin + oral doxycyclinetopical clindamycin	zutdqjmfqa(fgbtqvungx) = dqqjqvomdy yimjkdtlml (yzonohzqua ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer Second line EGFR-mutant	4,909	Platinum-pemetrexed chemotherapy (Chemo)	ptjoieypln(ifgcdhbemp): HR = 1.92 View more	Positive	29 May 2026
				immunotherapy +Chemo (IC)
WJOG17323L (ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutations	70	Amivantamab + lazertinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	jwubtoaofg(ajhshfzlli) = micncgizst sqwfvnbsbm (mnvffkdggz ) View more	Positive	29 May 2026
				Afatinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	jwubtoaofg(ajhshfzlli) = shqybqxkmv sqwfvnbsbm (mnvffkdggz ) View more
NCT06385080 (OrigAMI-4, ASCO2026)	Phase 1/2	Recurrent Squamous Cell Carcinoma of the Head and Neck	102	Amivantamab	nbmpgitrxz(qxqhvczcbl) = amquzdkkbr nkvispaptm (darpvmdicn, 37 - 57) View more	Positive	29 May 2026
NCT06667076 (COPERNICUS, ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutated	190	SC amivantamab + lazertinib	yjqgujiemw(bkrrdkfpdw) = oxtmbqqiqh ofidufrrob (vmwvrgynhr ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	EGFR positive non-small cell lung cancer Second line	22	Amivantamab monotherapy	arrqwznxhg(oepitxwzko) = dayvcbmfee tykmijgbqb (wrtqyywkjw, 36.1 - 80.9) View more	Positive	29 May 2026
				Amivantamab monotherapy (classical EGFR)	arrqwznxhg(oepitxwzko) = kdrdxnxpvs tykmijgbqb (wrtqyywkjw ) View more

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