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

Structure/Sequence

Sequence Code 143885L

Source: *****

Sequence Code 13387733H

Source: *****

Sequence Code 13387743H

Source: *****

Sequence Code 13387747L

Source: *****

Clinical Trials associated with Amivantamab-VMJM

NCT07586202

/ Not yet 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

NCT07507188

/ Not yet recruitingPhase 2IIT

Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)

* In this study, we hypothesized that immune engagement by amivantamab will enhance antitumor efficacy by modulating the immune microenvironment in combination with lazertinib in patients with untreated EGFR-mutant NSCLC or with chemotherapy (carboplatin plus pemetrexed) after progression with 3rd generation (3G) EGFR TKI.
* The primary objective of this study is to examine the patients' tumors for immunomodulatory effects of amivantamab-based regimens.
* In a phase 2, two cohort clinical trial, treatment naïve patients with EGFR-mutant NSCLC will be treated with amivantamab SC plus oral lazertinib (Cohort 1, n=30) or patients with EGFR-mutant NSCLC progressed on or after 3G EGFR TKI treated with amivantamab SC plus chemotherapy (Cohort 2, n=30).

Start Date06 Apr 2026

Sponsor / Collaborator

Yonsei University

NCT07062354

/ Enrolling by invitationPhase 2IIT

A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

This research study is for people who have head and neck cancer that has come back or spread to other places in the body.

Start Date25 Mar 2026

Sponsor / Collaborator

SWOG

[+2]

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

281

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.

04 May 2026·Expert Opinion On Drug Safety

Evaluation of the safety profile of amivantamab based on real-world evidence: a call to vigilance

Article

Author: Liao, Zuyue ; Wang, Yu ; Jiang, Zhongcai ; Luo, Cheng ; Wei, Hongqun ; Huang, Yinghua

BACKGROUND:

Amivantamab has been approved for EGFR exon 20 insertion-mutated non-small-cell lung cancer. The aim of this study was to perform an in-depth analysis of its safety profile.

RESEARCH DESIGN AND METHODS:

Safety reports were collected from the database of the Food and Drug Administration Adverse Event Reporting System from April 2021 to September 2023, and the reporting odds ratio (ROR) method was used to detect potential safety signals. Mobocertinib, an agent with similar properties to amivantamab, served as a control for comparison.

RESULTS:

A total of 88 safety signals were detected, most of which were novel. In comparison with mobocertinib, amivantamab appeared to cause more injury, poisoning, and procedural complications (ROR = 15.54, 95% CI 10.25-23.58); respiratory, thoracic, and mediastinal disorders (ROR = 1.92, 95% CI 1.57-2.34); infections and infestations (ROR = 1.39, 95% CI 1.09-1.76); blood and lymphatic system disorders (ROR = 9.57, 95% CI 6.17-14.84); and immune system disorders (ROR = 6.41, 95% CI 3.14-13.12). Moreover, amivantamab was associated with higher risks of thrombosis events, bone marrow suppression, skin and soft tissue infection, deterioration of respiratory symptoms, and noninfectious pneumonitis.

CONCLUSION:

The safety profile of amivantamab requires attention; particularly, monitoring of the adverse drug events described above is necessary during its administration.

01 May 2026·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

Author: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

351

News (Medical) associated with Amivantamab-VMJM

22 May 2026

·www.prnewswire.com

Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload

Agreement with Hangzhou DAC Provides Option for Up to Five New, Internally Developed ADC Programs, Including Dual-Payload Variations Hangzhou DAC's DXC006 Data at ASCO Reinforce Conviction for CPT113, a Core Technology of Whitehawk's ADC Platform Phase 1 Dose-Escalation Trials of HWK-007 and HWK-016 are Currently Enrolling; HWK-007 Trials-in-Progress Poster to be Presented at ASCO MORRISTOWN, N.J., May 21, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced it entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk's ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index. Per the terms of the option agreement, Whitehawk will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months. "This option agreement reflects our conviction in CPT113 as the core linker-payload foundation of our ADC platform, supported both by increasing external validation and by what we are seeing in our own existing programs. By layering on our proprietary CBCR bioconjugation process, we believe we further enhance ADC stability to deliver potential best-in-class ADCs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "With HWK-007 and HWK-016 enrolling, and an IND for HWK-206 anticipated mid-year, we are building execution momentum across our portfolio. We now have the opportunity to further scale our pipeline and advance novel ADC programs toward the clinic in the next 12-24 months." External Programs Validate CPT113 Linker-Payload Technology Hangzhou DAC's DXC006 is a CD56-directed ADC that utilizes CPT113. DXC006 is being evaluated in first-in-human Phase 1 dose escalation/expansion study in China (NCT06224855) in solid tumor populations, including small-cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and neuroendocrine neoplasms. Data from DXC006 were accepted for oral presentation at the American Society of Clinical Oncology Annual Meeting (ASCO). The abstract points to this highly potent linker-payload translating to clinical activity and a favorable safety profile characterized by an absence of key safety concerns typically associated with a Top1i class. These abstract data were as of December 26, 2025. Separately, at the American Association for Cancer Research (AACR) Annual Meeting, Johnson & Johnson disclosed JNJ‑95437446, an amivantamab-based EGFR/MET ADC that uses CPT113. In the poster, JNJ‑95437446 reported preclinical findings that support its ongoing Phase 1 clinical development (NCT07107230). Whitehawk's ADC platform builds on the CPT113 linker-payload technology with its proprietary CBCR bioconjugation process. Based on key nonclinical measures, Whitehawk's CBCR-based ADC platform has demonstrated higher Drug-to-Antibody Ratio (DAR) and improved therapeutic index compared to DXC006. Whitehawk recently reported comprehensive preclinical data for its existing pipeline programs at AACR. Whitehawk's Clinical Pipeline Phase 1 trials for PTK7-directed HWK-007 and MUC16-directed HWK-016 are advancing through dose-escalation, with data expected in the first half of 2027. Based on non-clinical modeling, both programs' starting dose is expected to be above the anticipated minimally effective dose. HWK-007 completed the first dose cohort at 2 mg/kg and is enrolling the second cohort at 4 mg/kg. HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The design of this Phase 1 study will be presented during a Trials-in-Progress poster at ASCO. Title: A phase 1 study of HWK-007, a next-generation, protein tyrosine kinase 7 (PTK7)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors Date & Time: May 30, 2026, 1:30-4:30 PM CDT Poster: 292b HWK-016 is enrolling the first dose cohort at 2.5 mg/kg. HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853). About Whitehawk Therapeutics Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at and connect with us on LinkedIn. Any references to the Company's website or other online resources are provided solely for convenience and are not incorporated by reference into this press release. Investors should rely only on the information contained in this press release and the Company's filings with the Securities and Exchange Commission. Forward Looking Statements This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, the anticipated timing of the Company's development of the new programs under its option agreement with Hangzhou DAC, including the expected submission of Investigational New Drug applications for multiple new programs over the next 12-24 months; anticipated timing of initial Phase 1 data from clinical trials for HWK-007 and HWK-016 in 1H 2027 and expectations with respect to both programs' starting dose; statements relating to expectations regarding the beneficial characteristics, optimized ADC design features, safety, efficacy, and therapeutic effects of the Company's portfolio, including expected enhanced ADC stability to deliver potential best-in-class ADCs; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund its future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with preclinical and clinical development of the Company's portfolio, including failure to demonstrate the efficacy of the such portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, including under the caption "Item 1A. Risk Factors," and in Whitehawk's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk's reports and other documents that Whitehawk has filed, or will file, with the SEC from time to time and available at . All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: [email protected] SOURCE Whitehawk Therapeutics, Inc. 21% more press release views with Request a Demo

Phase 1License out/inAACRADCASCO

22 May 2026

·allsci.com

Whitehawk Therapeutics licenses Hangzhou DAC’s CPT113 linker-payload for up to five ADC programs

Whitehawk Therapeutics (Nasdaq: WHWK) has entered an option agreement with China’s Hangzhou DAC Biotech to access the CPT113 linker-payload technology across up to five new ADC programs, including dual-payload variations. The Morristown, New Jersey-based Whitehawk, which relaunched from Aadi Bioscience in 2025 to focus on antibody-drug conjugates, will select targets and source antibodies independently while retaining global rights and full program control. Financial terms were not disclosed. CPT113 is a camptothecin-based topoisomerase I (Top1) inhibitor linker-payload developed by Hangzhou DAC. Top1 inhibitor payloads work by inducing DNA single-strand breaks in tumor cells, triggering apoptosis — the same mechanism used by DXd in trastuzumab deruxtecan (Enhertu) and SN-38 in sacituzumab govitecan (Trodelvy). Whitehawk describes CPT113 as a differentiated next-generation payload within this class, though the specific chemical distinctions from DXd and SN-38 are not fully disclosed in company materials. Whitehawk’s approach layers its proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process on top of the CPT113 payload. CBCR is described by the company as a site-specific conjugation method that reduces the native interchain disulfide bonds of the antibody and re-bridges the resulting free cysteines using a carbon-based crosslinker, producing a more homogeneous ADC with a defined drug-to-antibody ratio (DAR). In nonclinical comparisons against Hangzhou DAC’s own CPT113-based ADC, DXC006, Whitehawk reported higher DAR and improved therapeutic index — though these data are preclinical and have not been validated in a controlled head-to-head clinical setting. Whitehawk’s existing three-asset pipeline — HWK-007, HWK-016, and HWK-206 — is separately in-licensed from WuXi Biologics (HKEX: 2269.HK) under an exclusive global development and commercialization agreement. The new Hangzhou DAC option expands the CPT113 access that already underpins those programs to cover up to five additional, internally developed candidates. The company anticipates submitting IND applications for multiple new programs within 12 to 24 months. Both of Whitehawk’s lead clinical programs are currently enrolling. HWK-007, a PTK7-directed ADC, received IND clearance in January 2026 and has completed the first dose cohort at 2 mg/kg in a Phase I trial evaluating patients with non-squamous EGFR wild-type NSCLC, platinum-resistant ovarian cancer, and endometrial cancer. HWK-016, a MUC16-directed ADC, entered Phase I first-in-human testing in March 2026 and is enrolling the first dose cohort at 2.5 mg/kg in ovarian and endometrial cancers (NCT07470853). Initial data from both programs are expected in the first half of 2027. An IND for HWK-206 is anticipated mid-year 2026. Whitehawk cited two external programs using CPT113 as validation for the payload’s clinical credentials. Hangzhou DAC’s DXC006, a CD56-directed ADC, is in a Phase I dose-escalation and expansion study in China (NCT06224855) in SCLC, NSCLC, and neuroendocrine neoplasms, with data accepted for oral presentation at ASCO 2026. Johnson & Johnson (NYSE: JNJ) separately disclosed JNJ-95437446, an amivantamab-based EGFR/MET ADC using CPT113, at AACR 2026, supported by preclinical data from an ongoing Phase I trial (NCT07107230). The option structure — covering up to five programs with global rights retained by Whitehawk and no disclosed economics — is consistent with multi-target payload licensing arrangements that have become common in the ADC space, where linker-payload providers grant access to platform technology on a per-program basis rather than through single-asset deals. In January 2026, Lonza’s Synaffix unit signed a multi-target license agreement with Sidewinder Therapeutics to advance next-generation bispecific ADCs using Synaffix’s clinically validated ADC platform — a structurally comparable arrangement in which the technology provider licenses access across multiple programs while the drug developer controls target selection and development. The timing of the Hangzhou DAC agreement coincides with rising pharma interest in the CPT113 payload specifically. J\&J’s use of CPT113 in an amivantamab-based ADC is a notable signal, given that amivantamab is an approved bispecific targeting EGFR and MET. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 1License out/inADCIND

21 May 2026

·endpoints.news

At ASCO, drugmakers to offer options after Keytruda in head and neck cancer

Head and neck cancer has always been a tough nut to crack. These tumors can suppress immune responses through multiple pathways, meaning blocking one of those usually isn’t enough. Merck’s Keytruda is approved for head and neck squamous cell carcinoma (HNSCC). But the patients most likely to respond to Keytruda are those with high PD-L1 expression. And within that subgroup, response rates aren’t as high as for some other cancer types. This leaves many HNSCC patients in need of more effective options. Drugmakers are exploring a variety of approaches to treat the condition, from bispecific antibodies that target both PD-1 and VEGF to antibody-drug conjugates (ADCs) that deliver more targeted attacks. On Thursday, some of these companies published abstracts for data presentations at this year’s American Society of Clinical Oncology’s annual meeting, starting next week in Chicago. Endpoints News rounded up four key abstracts in the space. Johnson & Johnson’s efforts to expand the scope of its lung cancer treatment Rybrevant seem to be off to a promising start. The company said the bispecific antibody, which targets MET and EGFR, achieved a 47% objective response rate (ORR) in 102 people with recurrent or metastatic HNSCC enrolled in a registrational Phase 1/2 study. The patients’ cancer was not related to HPV infection, and they had all previously been treated with a PD-(L)1 inhibitor and platinum-based chemotherapy. The median duration of response was 7.2 months among those who responded to treatment. J&J has said Rybrevant could reach $5 billion in peak sales, although the drug is still early in its journey toward this target. The company reported that Rybrevant combined with Lazcluze pulled $734 million in 2025 sales. Corbus Pharmaceuticals is also targeting recurrent or metastatic HNSCC with its next-generation Nectin-4 directed ADC, known as CRB-701. Both the higher and lower doses of CRB-701 led to a 33.3% ORR in separate cohorts of patients enrolled in a Phase 1/2 trial. The lower 2.7 mg/kg dose data came from 12 patients, while the higher 3.6 mg/kg dose results were from 21 patients. There were a few more unconfirmed responses in the higher-dose cohort, Corbus said. Last month, Mizuho Securities analysts wrote that CRB-701 could reach $3.6 billion in global peak sales, with most expected to come from HNSCC and the remainder from cervical cancer. Corbus said CRB-701 is designed to have a lower drug-to-antibody ratio and longer half-life than other medicines from the same class, like Pfizer’s Padcev. These differences could result in a better safety profile and less frequent dosing. Common side effects seen in both HNSCC and cervical cancer included keratitis, fatigue, alopecia and anemia. While Summit Therapeutics’ and Akeso’s ivonescimab has garnered the most attention for its prospects in lung cancer , investigators in China are also testing the PD-1xVEGF bispecific in locally advanced HNSCC. Ivonescimab is being studied in the neoadjuvant setting, which means that patients receive three cycles of the drug in combination with chemotherapy before undergoing surgery to remove their cancer. The candidate produced a 100% ORR in 34 patients evaluated before the third round of treatment in the Phase 2 trial. After the third round, a complete pathological response (pCR) was achieved in 70% of patients with primary lesions and 64.3% of those with lymph node metastases. The overall pCR rate was 50%. Goldman Sachs analysts have projected ivonescimab could make a whopping $53 billion in global peak sales. Several large drugmakers have joined the PD-(L)1xVEGF race through deals in recent years, including AbbVie , Pfizer and Bristol Myers Squibb . Summit itself bet up to $5 billion when it first partnered with Akeso on ivonescimab back in 2022. Bicara Therapeutics’ ficerafusp alfa is designed to block EGFR and also trap a cytokine called TGF-β that creates an immunosuppressive tumor environment. Cantor Fitzgerald analysts have said the drug could reach over $1 billion in peak sales. The treatment was administered to 85 patients with HPV-negative recurrent or metastatic HNSCC as part of Bicara’s Phase 1/1b trial. Bicara said the drug led to ORRs of 57%, 54% and 48% at the 750 mg, 1500 mg and 2000 mg doses, respectively. The average length of progression-free survival (PFS) depended on whether patients had a “deep response,” or a minimum 80% tumor regression. The median PFS was 26.4 months for patients with a deep response and 6.5 months for those without one.

Clinical ResultASCOPhase 2Drug ApprovalADC

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	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
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Cilag AG	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


NCT05074940 (Phase 2 clinical trial, CTgov)	Phase 2	Adenoid Cystic Carcinoma \| Salivary Gland Neoplasms	21	Amivantamab	iphitositr = hpctkjhmzj bwxjwvytvz (psygijzenv, cjusfclkzc - xlvixftrrp) View more	-	08 May 2026
NCT06750094 (OrigAMI-3, AACR2026)	Phase 3	RAS/BRAF Wild Type Colorectal Cancer Second line RAS/BRAF WT	700	Amivantamab plus FOLFIRI	zbgjbzrsco(pxeexyelmp) = pqmqckjkon wiqabzwloj (rhwkljzmqo )	Positive	21 Apr 2026
				Cetuximab or Bevacizumab plus FOLFIRI	ewcaultvik(jliamcjcji) = uhgkyamguo dsoikytzao (fchfahcqdf )
NCT06662786 (OrigAMI-2, AACR2026)	Phase 3	RAS/BRAF Wild Type Colorectal Cancer First line RAS/BRAF WT	1,000	Amivantamab + FOLFOX/FOLFIRI	zqjgvvpflr(vkizivqqmi) = xwofhcdowr lyjjrjeyyl (smpshoqnzo )	Positive	21 Apr 2026
				Cetuximab + FOLFOX/FOLFIRI	obaiiruuad(pgtyituebw) = wrfodtkdtd tnosinhdhq (opzshipztk ) 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)	vvwqyfdgar(ilpohalwlb) = fzayzsufos yfsmofqqzw (dwzgcnzoxr ) View more	Positive	21 Apr 2026
				Amivantamab (cohort B)	vvwqyfdgar(ilpohalwlb) = xyjodzjzvu yfsmofqqzw (dwzgcnzoxr ) View more
NCT05379595 (OrigAMI-1, AACR2026)	Phase 1/2	Metastatic Colorectal Carcinoma RAS/BRAF wild-type	1	Amivantamab	ssizwxfsbl(hpbxwpnetm) = Amivantamab demonstrated increased binding and functional activity against a wider range of EGFR ECD mutations, including the most prevalent V441, G465, and S492 mutations, relative to cetuximab and panitumumab. igskzqrozu (lqxbtrkzuz ) View more	Positive	20 Apr 2026
NCT05074940 (Pubmed \| JAMA Otolaryngol Head Neck Surg)	Phase 2	Adenoid Cystic Carcinoma	18	Amivantamab	ownkolyeqn(qsqglxhvqw) = kzqahzqxlk kqnkldbmdh (qnwieudogr, 0 - 27.6) View more	Negative	01 Apr 2026
ESMO_ELCC2026	Not Applicable	Non-Small Cell Lung Cancer	58	Amivantamab +/- chemotherapy	htuhxchslb(nvnjhtyktm) = ehsibmezby msvbkibaqn (gxujkcfpwf ) View more	Negative	25 Mar 2026
				Amivantamab + EGFR-TKI	htuhxchslb(nvnjhtyktm) = plyiaueddv msvbkibaqn (gxujkcfpwf ) View more
NCT04538664 (PAPILLON, Pubmed \| Lung Cancer)	Phase 3	Advanced Lung Non-Small Cell Carcinoma First line EGFR exon 20 insertion	186	Amivantamab-chemotherapy	bnifiljrux(tbjpqsugzh) = xqpdxcsruk gjgqncjedx (ycgrtqpphw, 9.8 - 13.9) View more	Positive	01 Mar 2026
				Chemotherapy	bnifiljrux(tbjpqsugzh) = yhtqwjwhgc gjgqncjedx (ycgrtqpphw, 4.2 - 7.4) View more
NCT04965090 (Pubmed \| J Thorac Oncol)	Phase 2	EGFR Mutation Lung Cancer EGFR-activating mutations \| exon 20 insertions	41	Amivantamab + lazertinib (brain metastases (BrM))	ixppmuqpav(ynklfuzarp) = fiarqvqvbf bzdwkdyaeo (zdznjbgpbe, 27 - 73) View more	Positive	01 Mar 2026
				Amivantamab + lazertinib (leptomeningeal disease (LMD))	ixppmuqpav(ynklfuzarp) = efhkvojbfr bzdwkdyaeo (zdznjbgpbe, 15 - 57) View more
NCT05388669 (PALOMA-3, CTgov)	Phase 3	Advanced Lung Non-Small Cell Carcinoma \| metastatic non-small cell lung cancer \| EGFR-mutated non-small Cell Lung Cancer	418	Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)+Lazertinib (Arm A: Lazertinib With Amivantamab SC-CF)	bwulfprlhc(odwqcwgppg) = luvdferysz ppokxacdid (tovjgbxwef, 39.1) View more	-	02 Feb 2026
				Amivantamab Intravenous+Lazertinib (Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion)	bwulfprlhc(odwqcwgppg) = quywqaaqox ppokxacdid (tovjgbxwef, 41.5) View more

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