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

NCT07042295

/ Not yet recruitingPhase 2IIT

A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma

This phase II trial compares the effect of amivantamab and hyaluronidase to cetuximab for the treatment of skin (cutaneous) squamous cell carcinoma that has come back after a period of improvement and has not spread to other parts of the body (locally recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Amivantamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hyaluronidase is an endoglycosidase. It helps to keep amivantamab in the body longer, so that the medications will have a greater effect. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.

Start Date22 Dec 2025

Sponsor / Collaborator

National Cancer Institute

NCT07062354

/ Not yet recruitingPhase 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 Date01 Dec 2025

Sponsor / Collaborator

SWOG

[+2]

NCT06855849

/ Not yet recruitingPhase 2IIT

An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.

This trial is a multicenter, single arm study of efficacy of amivantamab in combination with FOLFIRI in RAS/BRAF wild-type advanced colorectal cancer patients progressed prior treatment including oxaliplatin based chemotherapy. This trial will be conducted by Severance Hospital that is responsible for the project management of the trial. Patient recruitment will take at 3 institutions.
Participants will be treated for up to 24 cycles (approximately 2 years) after initiation of treatment with intravenous 1050mg(BW<80kg) or 1400mg(BW≥80kg) of amivantamab every 4 weeks in combination with FOLFIRI. FOLFIRI includes folic acid, 5-FU and irinotecan. FOLFIRI will be administered intravenously with folic acid 400 mg/m², 5-FU 2400 mg/m², and irinotecan 180 mg/m² every 2 weeks. This study will use ORR based on RECIST 1.1 criteria as the primary endpoint and the tumor assessment will be done every 8 weeks. Secondary endpoints are DCR, PFS, OS, and safeties. Exploratory biomarkers in tumor tissue and ctDNA in blood will be investigated in both pre-treatment and post-treatment periods.

Start Date01 May 2025

Sponsor / Collaborator

Yonsei University

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

225

Literatures (Medical) associated with Amivantamab-VMJM

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Dec 2025·BIOCHEMICAL PHARMACOLOGY

Comprehensive non-small cell lung cancer targets: From computational prediction to clinical breakthroughs in overcoming drug resistance

Review

Author: He, Zhiheng ; Guo, Li ; Gong, Chengjun ; Zhang, Yuting ; Wang, Baojie ; Liu, Jiarui ; Zheng, Wanjie ; Liang, Tingming ; Shen, Jie

Non-small cell lung cancer (NSCLC), the predominant subtype of lung cancer, remains a leading contributor to global cancer-related mortality. Conventional treatments-surgery, chemotherapy, and radiotherapy-are often limited by suboptimal efficacy and substantial toxicity, underscoring the urgent need for more effective targeted therapies. This study provides a comprehensive overview of three key advancements in NSCLC research. First, it highlights state-of-the-art target prediction methodologies that integrate ligand-based, structure-based, and multi-feature deep learning models, supported by experimental validation. Second, it examines clinical progress in targeting classical oncogenic drivers, exemplified by the fourth-generation tyrosine kinase inhibitor amivantamab against epidermal growth factor receptor (EGFR), and explores mechanisms of drug resistance, such as T790M and C797S mutations, along with emerging strategies like synthetic lethality-based interventions. Third, it discusses combination regimens-such as osimertinib co-administered with savolitinib-that mitigate resistance by synergistically inhibiting compensatory signaling pathways, thereby enhancing clinical outcomes. Future research priorities include the design of multi-target therapeutics and the refinement of AI-driven target discovery frameworks. This review addresses current limitations in targeted NSCLC therapy and offers insights to guide future therapeutic development.

01 Nov 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Optimizing management of cutaneous toxicities from amivantamab in first-line non-small cell lung cancer: A clinical perspective

Letter

Author: Tosti, Giulio ; Passaro, Antonio ; de Marinis, Filippo ; Pepe, Francesca ; Attili, Ilaria

Amivantamab, a bispecific EGFR-MET antibody, has demonstrated efficacy in EGFR-mutant non-small cell lung cancer (NSCLC) across multiple trials and is poised to enter first-line therapy. However, as with EGFR-targeted therapies, amivantamab is associated with distinctive cutaneous toxicities. This perspective summarizes clinical evidence on the frequency, nature, and severity of skin-related adverse events from key studies, outlining how, despite concerns initially raised among clinicians about its tolerability in routine practice, clinical experience indicates that amivantamab's cutaneous toxicities are manageable with proactive strategies and education. Acneiform rash, paronychia, and xerosis are among the most common toxicities observed, generally low-grade but impacting patient quality of life. Emerging evidence and expert consensus indicate that these cutaneous events are manageable with patient education, multidisciplinary dermatologic care, and proactive interventions. Proactive management roughly halved the incidence of moderate-to-severe rash and significantly reduced high-grade events, enabling most patients to continue therapy. In practice, close collaboration with experienced dermatologists, early management of symptoms, and thorough patient education on skincare can dramatically improve tolerability. As a result, initial fears about severe skin toxicity can be overcome, ensuring that patients are not denied the benefits of this efficacious therapy due to manageable side effects. In light of the significant survival benefit shown by amivantamab-based therapy in the MARIPOSA trial, preventing, recognizing and optimally managing its skin toxicities will be crucial to maximizing patient outcomes.

303

News (Medical) associated with Amivantamab-VMJM

04 Nov 2025

·www.prnewswire.com

Actinium Pharmaceuticals, Inc. to Highlight ATNM-400 Data in Hormone-Resistant and HER2-Resistant Breast Cancer at the 2025 San Antonio Breast Cancer Symposium, Expanding Pan-Tumor Profile Across Three Solid Tumor Indications

- New preclinical data to show anti-tumor activity of ATNM-400 in hormone-resistant and HER2-resistant breast cancer, addressing the need for new treatment options beyond tamoxifen and trastuzumab - ATNM-400 demonstrates efficacy across prostate cancer, non-small cell lung cancer (NSCLC), and breast cancer - three of the largest oncology indications - with potential as monotherapy, in combination, or as an alternative therapy NEW YORK, Nov. 4, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or the "Company"), a leader in the development of differentiated targeted radiotherapies, announced today that new preclinical data for its lead antibody radioconjugate program, ATNM‑400, will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place December 10‑14, 2025 in San Antonio, Texas. Title: Anti‑tumor activity of ATNM‑400, a first‑in‑class Actinium‑225 antibody radioconjugate, in tamoxifen and trastuzumab resistant breast cancer models Abstract Number: 2069 Presentation Number: PS4‑04‑26 Date/Time: Thursday, December 11, 2025, 5:00 PM–6:30 PM CT Session: Poster Session 4 The ATNM-400 data presentation at SABCS follows prostate cancer data presentations at the American Association for Cancer Research (AACR) annual meeting and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, NSCLC data was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, from which key findings are summarized below. ATNM ‑ 400: Program and Multi-Indication Opportunity Overview ATNM-400 is a first-in-class antibody-radioconjugate powered by Actinium-225 (Ac-225), designed to deliver potent alpha-particle radiation directly to tumor cells. The therapy's high linear energy transfer (LET) enables precise tumor cell killing with minimal off-target exposure, while its target - a disease-driving protein linked to resistance and poor prognosis - is overexpressed across multiple solid tumors, including prostate, lung, and breast cancers. Preclinical studies show ATNM-400 delivers best-in-class efficacy, overcomes resistance to, and synergizes with, standard-of-care therapies, supporting broad development as a monotherapy, combination, or treatment alternative across multiple solid tumors. Prostate Cancer Data Highlights Superior efficacy and durability vs 177Lu-PSMA-617 (active agent in Pluvicto®), 225Ac-PSMA-617, and ARPI enzalutamide (active agent in Xtandi®), with durable tumor control beyond 100 days. Improved overall survival compared to 177Lu-PSMA-617 and enzalutamide. Overcomes resistance to these standard-of-care agents, showing sustained tumor control and survival benefit in 177Lu-PSMA-617 and enzalutamide resistant prostate cancer models. Synergy with ARPI therapy as the ATNM-400 target is upregulated after enzalutamide; combination achieved complete tumor regression in 40% of animals. PSMA-independent activity enables treatment of patient populations not eligible for or progressing on 177Lu-PSMA-617. NSCLC Data Highlights 3–5x greater tumor growth inhibition vs. front-line osimertinib (Tagrisso®, AstraZeneca) and EGFR tyrosine kinase inhibitor (TKI), second-line Dato-DXd (Datroway®, AstraZeneca/Daiichi Sankyo) a Trop-2 ADC, and third-line amivantamab (Rybrevant®, Johnson & Johnson) an EGFR-cMET bispecific. Combined 2024 sales of these agents exceeded $7B. Target upregulation following EGFR inhibition; ATNM-400 + osimertinib achieved complete tumor regression in 100% of tumor-bearing animals demonstrating synergy of the combination. Clinical rationale for combination supported by a study that showed EBRT or external-beam radiotherapy + osimertinib improved PFS to 32.2 months vs. 20 months with osimertinib alone (Sampath et al.1, Lancet eClinicalMedicine, 2025). ATNM-400 has the potential to deliver precision targeted, powerful alpha radiation via Ac-225 which on a per-cell basis is ~4–8x more biologically lethal than diffuse, low-energy EBRT beams. Clinically, this may translate to higher response rates, lower toxicity, and entry into previously untreatable market segments when osimertinib is combined with EBRT. ATNM-400 Data Afford Development Opportunities in High-Value, Unmet Need Indications The data package for ATNM‑400 across breast cancer, prostate cancer and NSCLC underscores Actinium's intention to demonstrate the potential for this radiotherapy candidate to address unmet needs in high‑value cancer segments. Data from preclinical studies thus far show ATNM-400 delivers best-in-class efficacy, overcomes resistance to, and synergizes with, standard-of-care therapies, supporting broad development as a monotherapy, combination, or treatment alternative across solid tumors. Key development opportunities based on the data include: Breast Cancer: Potential in hormone‑resistant (tamoxifen) and HER2‑resistant (trastuzumab) patients, which represents a significant therapeutic opportunity with the HER2-targeted therapy Herceptin® (Roche and biosimilars) generating approximately $4.0 billion in sales in 2024. Prostate Cancer: Broad use potential as a monotherapy, combination, or follow-on to ARPIs and PSMA radioligands; opportunity in the $10 billion ARPI market and Pluvicto non-responders or relapses who on balance might be expected to outnumber the patients treated with Pluvicto which generated $1.7 billion in revenue over the last twelve months. Non-Small Cell lung Cancer: Superior anti-tumor activity compared to the leading first, second and third-Line approved EGFR mutant therapies that generated sales of over $7.0 billion in 2024 and mechanistic synergy with first-line therapy osimertinib, which accounted for approximately $6.6 billion in sales in 2024. Sandesh Seth, Chairman and CEO of Actinium Pharmaceuticals, commented, "We're excited to present ATNM-400's breast cancer data at SABCS which expands our demonstration of its potential across multiple solid tumors. The strong single-agent efficacy of ATNM-400 and its ability to overcome resistance when coupled with enzalutamide (Xtandi®) in prostate cancer and osimertinib (TAGRISSO®) in lung cancer showcases Actinium's capability for innovation by exploiting the power of a radiotherapeutic directed to a target linked to resistance and poor prognosis. We believe that this program has the potential to meaningfully improve outcomes for patients with difficult-to-treat cancers and look forward to the data at SABCS". About ATNM-400 ATNM-400 is a highly innovative, first-in-class, and multi-indication Actinium-225 (Ac-225) targeted radiotherapy candidate in development for prostate cancer, non-small cell lung cancer (NSCLC) and breast cancer. ATNM-400 is highly differentiated in prostate cancer as it targets a distinct non-PSMA protein strongly implicated in prostate cancer disease biology including progression and treatment resistance. Unlike 177Lu-PSMA-617, the active agent in Pluvicto® and the majority of radiotherapies under development, which rely on PSMA targeting, ATNM-400 is designed to maintain efficacy in low-PSMA or high-PSMA resistant disease, a major unmet clinical need as up to 30% of patients do not respond to PSMA radioligand therapies and up to 60% of patients have at least one PSMA-negative tumor lesion. Ac-225 delivers high-linear-energy-transfer alpha particles that induce irreparable double-strand DNA breaks, offering superior potency over beta emitters like Lutetium-177 (177Lu), and has a shorter tissue path length that may reduce off-target toxicity. The receptor specifically targeted by ATNM-400 continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and ATNM-400 has shown to overcome resistance to the ARPI therapy enzalutamide and work synergistically in combination with enhanced tumor control including complete tumor regression. In NSCLC, ATNM-400 has shown superior efficacy compared to approved first, second- and third-line EGFR therapies including small molecules, antibody drug conjugates and bispecific antibodies that is synergistic with osimertinib, an EGFR tyrosine kinase inhibitor (TKI) that is a standard of care therapy approved for treatment of patients in the frontline setting and is also able to overcome osimertinib resistance. Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC - a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto®, which had sales of over $1.3 billion in 2024, yet up to 30% of patients either lack or have no PSMA expression and virtually all patients develop resistance to Pluvicto® within 1-year. In the U.S., 40,000–60,000 mCRPC patients annually progress after ARPI therapy with approximately 35% of patients progressing within 1-year. As a class, ARPI therapies had sales of over $10.0 billion in 2024 including enzalutamide (Xtandi®) that led the class with sales of over $5.9 billion in 2024, highlighting a significant unmet need. Lung cancer is the leading cause of cancer deaths and there are there are over 200,000 new cases expected in the U.S. in 2025 and over 2 million cases globally. NSCLC accounts for approximately 85% of all lung cancer cases. EGFR targeting therapies including front-line osimertinib (Tagrisso®, AstraZeneca) an EGFR tyrosine kinase inhibitor (TKI), second-line Dato-DXd (Datroway®, AstraZeneca/Daiichi Sankyo) a Trop-2 ADC, and third-line amivantamab (Rybrevant®, Johnson & Johnson) an EGFR-cMET bispecific had sales of approximately $7 billion in 2024 with the EGFR TKI Osimertinib (TAGRISSO®, AstraZeneca) generating sales of $6.6 billion in 2024. Breast cancer is the most diagnosed cancer among woman in the United States with approximately 316,950 women expected to be diagnosed with the disease in 2025 according to the National Cancer institute. It is estimated that approximately 200,000 women are living with metastatic breast cancer in 2025, which is expected to grow to 250,000 in 2030. Of those diagnosed, hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer accounts for 70-75% of breast cancer, representing the largest subtype. In this setting, tamoxifen and trastuzumab (Herceptin®, Roche and biosimilars) generated sales of approximately $4.0 billion in 2024. Across prostate cancer, NSCLC and breast cancer, ATNM-400 has demonstrated treatment paradigm changing potential in these indications, which have over 800,000 new cases in the U.S. alone. About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. ATNM-400, Actinium's lead product candidate, is a novel, first-in-class, and multi-indication Actinium-225 (Ac-225) in development for prostate cancer, non-small cell lung cancer (NSCLC) and breast cancer. The antigen specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression, poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and Pluvicto® treatment. ATNM-400 is supported by preclinical data demonstrating tumor-specific uptake, higher efficacy than androgen receptor inhibitor enzalutamide (Xtandi®) and 177Lu-PSMA-617 radiotherapy, the active agent in Pluvicto®, durable tumor control and potent efficacy in prostate cancer models resistant to both enzalutamide and 177Lu-PSMA-617. In addition, ATNM-400 has demonstrated synergy with enzalutamide. In NSCLC, ATNM-400 showed superior efficacy to EGFR targeting therapies including osimertinib (TARGRISSO®, AstraZeneca), Dato-DXd (DATROWAY®, AstraZeneca/Daiichi Sankyo) and amivantamab (RYBREVANT®, J&J) with synergistic activity in combination with osimertinib. In breast cancer, Actinium has been studied in hormone and HER-2 resistant settings with data to be presented at the San Antonio Breast Cancer Symposium in December 2025. The data generated to date with ATNM-400 supports its potential across treatment settings to be used either as a monotherapy, or in combination or sequenced with other therapies. Actinium's most advanced product candidate in development is Actimab-A, a CD33 targeting therapeutic, that is a potential backbone therapy for acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds approximately 240 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Sources: Sampath et al. Osimertinib plus consolidative radiotherapy for advanced EGFR mutant non-small cell lung cancer: a multicenter, single-arm, phase 2 trial. The Lancet eClinicalMedicine, Volume 87, 103435. (25)00367-0/fulltext. Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 21% more press release views with Request a Demo

Clinical ResultRadiation TherapyPhase 2

22 Oct 2025

·www.biospace.com

How J&J Kept Growing Amid the Erosion of Cornerstone Drug Stelara

iStock, Denis_prof The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that, until recently, accounted for 20% of innovative medicine sales. Johnson & Johnson has made a molehill out of a mountain. Facing the loss of exclusivity on a drug that accounted for 20% of innovative medicine sales in 2023, J&J has reshaped its business around other products and programs to leave analysts predicting a new era of growth for the company. The anticipated arrival of biosimilar versions of Stelara, J&J’s blockbuster autoimmune disease drug, has occupied analysts for years. J&J executives have fielded questions about their preparations since at least 2021, reflecting how important the anti-IL-12 and IL-23 antibody became to the company after sales of chronic inflammatory disease drug Remicade began to erode in the face of off-patent rivals. Stelara sales peaked at $10.9 billion in 2023. Biosimilar competition, first overseas and later in the U.S., caused sales to slip in 2024 and tumble further in 2025. Yet while sales of the drug fell 40% over the first nine months of 2025, J&J still grew global innovative medicine revenue by 5%. BioSpace , Annalee Armstrong Cutting and Investing The growth reflects J&J’s multi-year effort to adapt its business for a post-Stelara future. Some parts of the business have been sacrificed to enable investment in the most promising programs. In 2023, J&J axed clinical-phase programs targeting hepatitis B, HIV and respiratory syncytial virus and ended R&D at an infectious disease and vaccine site in the Netherlands. J&J CFO Joseph Wolk framed the infectious disease and vaccine changes in the context of Stelara at a Bernstein event in May; The company “probably had to cut some investment” to prepare for the entry of Stelara biosimilars, he said. J&J’s medtech business provides sales to offset slowdowns at the medicines unit but the company nonetheless had to pull back from some areas. “We still make choices. You saw last year we exited infectious diseases and vaccines. We still prioritize, but it gives us a lot more flexibility to manage for that long term and have the robust pipeline and the growth outlook we have for the balance of this decade,” Wolk said. As J&J pulled back from infectious diseases and vaccines, it invested in other areas to ensure new growth drivers were in place to ease the Stelara transition. At J&J’s immunology unit, rising sales of Tremfya and Simponi are partly offsetting the decline of Stelara and the development of icotrokinra , JNJ-4804 and nipocalimab are laying the groundwork for a potential new-look portfolio. All three assets are in development for multiple indications, from plaque psoriasis to ulcerative colitis to psoriatic arthritis. The emergence of oncology as J&J’s tentpole business has allowed the company to weather a period of falling immunology sales. Five years ago, J&J reported nine-month oncology revenue of $8.9 billion. Oncology sales for the first nine months of 2025 were $18.5 billion. The growth reflects the blossoming of multiple myeloma drug Darzalex, plus product launches. Darzalex was a blockbuster in 2020, generating sales of $2.9 billion in just the first nine months of the year. It has grown significantly since then. The growth covers a period in which J&J launched a subcutaneous version of Darzalex and expanded the label. Sales hit $10.4 billion over the first nine months of 2025. J&J has also turned its prostate cancer drug Erleada, which was approved in 2019, into a multi-billion dollar a year product. The CAR T cell therapy Carvykti became J&J’s latest cancer blockbuster in the third quarter of 2025, when total sales for the year reached $1.3 billion. With sales of the bispecific antibodies Tecvayli, Talvey and Rybrevant still rising, and the bladder cancer drug Inlexzo new to the market, J&J is aiming to grow oncology revenues to $50 billion by 2030. The forecast was at least three times above the 2028 analyst consensus estimate when the company made the prediction in July, partly reflecting J&J’s belief that annual Inlexzo sales will exceed $5 billion. Guggenheim Securities analysts recently discussed Inlexzo’s prospects with a community urologist. J&J could face competition from CG Oncology’s oncolytic immunotherapy cretostimogene grenadenorepvec. The urologist told the analysts that the ability to keep Inlexzo at room temperature, the lack of biohazard requirements and the option to administer the drug at the office give J&J an advantage. “The speaker emphasized that in his community practice setting, practical convenience and logistical advantages would be the main determinants in choosing between the two products,” the analysts wrote in a note to investors. “As such, he envisions using Inlexzo in the large majority of his patients when both products are available in the future.” Deals Drive Growth Speaking on an earnings call in October, J&J CEO Joaquin Duato called Inlexzo an example of the company’s “outstanding business development model.” J&J acquired the asset through its 2019 takeover of Taris Biomedical. Wolk said on the earnings call that the company paid “a couple of hundred million dollars” for Taris, which was then in early clinical development. Duato said J&J has completed “more than 60 deals of this kind” in the past 18 months. J&J has struck the early-stage deals alongside bigger bets such as its $14.6 billion takeover of Intra-Cellular Therapies. The deal added the schizophrenia and bipolar depression drug Caplyta to J&J’s neuroscience portfolio. Caplyta generated $240 million in the third quarter, helping J&J grow neuroscience revenues despite sales of Concerta and Invega falling. Spravato is the other key product in J&J’s neuroscience portfolio. Sales grew more than 50% to near $1.2 billion over the first nine months of 2025. The drugs have established neuroscience as J&J’s third biggest innovative medicine unit after oncology and immunology. J&J’s pulmonary hypertension and cardiovascular units also have blockbuster drugs, giving the company a broad base to offset future challenges. The nature of the pharma industry means new challenges are inevitable. J&J is now receiving questions about potential price negotiations and patent expirations for Darzalex. Guggenheim analysts said they believe investors are “underappreciating Darzalex’s increased longevity and potentially improved economics,” but at some point J&J will need to adapt to pressure on its latest star drug. Having navigated the launches of Remicade and Stelara biosimilars over the past decade, the company has established a track record of managing such pressures and continuing to grow.

AcquisitionDrug ApprovalImmunotherapyBiosimilar

20 Oct 2025

·www.fiercebiotech.com

Merck grows more ambitious about \'workhorse\' TROP2 ADC as partner Kelun posts phase 3 wins

Merck has built a bullish view on sacituzumab tirumotecan across multiple cancer types based on promising data from other TROP2 antibody-drug conjugates and from its partner Kelun-Biotech in China.\n Oct. 14, days before the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Merck & Co. published a new clinical trial of sacituzumab tirumotecan (sac-TMT), in combination with the company’s PD-1 inhibitor Keytruda, as a first-line maintenance treatment for patients with cervical cancer. The TroFuse-036 study marked the 15th global phase 3 that the New Jersey pharma has launched for the TROP2 antibody-drug conjugate, licensed from China’s Kelun-Biotech, in the span of about three years.Meanwhile, detailed results from the phase 3 Leap-014 trial released at ESMO 2025 served as a poignant reminder of the disappointing outcomes the last time Merck went so aggressive on a cancer drug program.The Leap-014 trial, conducted in untreated patients with metastatic esophageal squamous cell carcinoma, missed its primary endpoint of overall survival (OS). Compared with Keytruda and chemo, Merck’s Eisai-partnered Lenvima—used in tandem with Keytruda and chemo—only showed an 8% reduction in the risk of death, which was not statistically significant. Patients in the experimental arm lived a median 17.6 months, versus 15.5 months for those in the control arm.As OS was not positive, the secondary endpoint of progression-free survival (PFS) was not tested for statistical significance. Data there were not promising, either, as the Lenvima-based regimen only reduced patients’ risk of progression or death by 11%.Leap-014 joins eight other phase 3 Leap trials in the failure category. Elsewhere, Leap-012 and Leap-015 have met on PFS but not OS, raising a degree of uncertainty about Merck and Eisai’s plans and whether regulators will be persuaded if the data are eventually submitted.But Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical development, remained bullish on sac-TMT.“I anticipate, across multiple tumor types and multiple indications, this is a workhorse drug,” Green said about sac-TMT in an interview with Fierce Pharma.Green built her optimism on promising data from other TROP2 ADCs and from Merck’s partner Kelun in China.“This is not the only TROP2 ADC out there. There are data sets from other companies,” Green said in an interview with Fierce Pharma. “The drugs are not identical—they have different therapeutic indexes—but there is a lot of data out there that supports the indications where we’ve moved sac-TMT.”Lenvima and sac-TMT address different biological questions, she added. While Lenvima is an anti-angiogenic drug, Green described sac-TMT as a targeted chemotherapy of a topoisomerase inhibitor.“We know that topoisomerase inhibitors are effective across all the tumor types where we have studies ongoing,” Green said. “And with the use of an antibody-drug conjugate, you’re able to get a more potent payload and improve the efficacy.”The large data sets Kelun has accumulated in China—some of which have not been publicly presented—offered a “significant amount of information that helped us to ungate these studies.”At ESMO 2025, Kelun detailed two recent positive Chinese phase 3 trials, offering a glimpse into what sac-TMT might one day achieve in its counterpart global studies. A unique EGFR lung cancer winIn patients with tyrosine kinase inhibitor-pretreated EGFR-mutant non-small cell lung cancer, sac-TMT significantly lowered the risk of death by 40% versus chemotherapy, according to results from a preplanned interim analysis of the OptiTROP-Lung04 trial. Median OS was not reached in the sac-TMT arm compared with a result of 17.4 months in the chemo group.Benefits were observed across subgroups analyzed, including in both those who had received a third-generation EGFR TKI in the first line and those who had one in the second line, as well as in patients with or without brain metastases and across EGFR mutation types. A small number of patients, 5.6% of the total randomized, had not received a prior third-gen TKI. The subgroup analysis does not include comparisons by TROP2 expression levels.Sac-TMT’s PFS benefit was also statistically significant, reaching 51% versus chemo by blinded central review, with a median PFS of 8.3 months versus 4.3 months, respectively.Sac-TMT achieved the OS showing even as 85.5% of patients in the chemotherapy arm received any subsequent treatment, including 19.6% who got an ADC. That’s compared to 72.3% of patients in the sac-TMT arm who got a follow-on therapy, including 1.4% for an ADC. In terms of safety, grade 3 or above treatment-related adverse events (TRAEs) were similar for sac-TMT and chemo, at 58% and 53%, respectively. Serious TRAEs were less frequent, at 9%, for sac-TMT, whereas the chemo group logged 17.6%.One important side effect of interest for sac-TMT is stomatitis, which is inflammation of the mucous membrane of the mouth, which can lead to painful oral ulcers. While not lethal, the problem can affect patients’ quality of life. The rate of any treatment-emergent stomatitis was 64%—including 5% at grade 3 with no more serious events—for sac-TMT, versus 5% in the chemo group, according to results published in The New England Journal of Medicine. The problem led to a 10.1% rate of dose reductions for sac-TMT but no discontinuations.Based on the results, Chinese authorities have already approved sac-TMT as a second-line treatment for EGFR-mutant NSCLC, Kelun announced Oct. 11.Besides the OS benefit, sac-TMT also comes with the advantage of being a single agent, while other regimens in this disease setting are combinations, the OptiTROP-Lung04 study investigators noted in the NEJM article. For example, in the HARMONi-A trial, which Akeso recently said also met its OS endpoint at the final analysis, the company’s PD-1xVEGF bispecific was used in combination with chemotherapy. Similarly, Johnson & Johnson’s FDA-approved antibody Rybrevant is also used together with chemo in second-line EGFR-mutant NSCLC.“I anticipate, across multiple tumor types and multiple indications, this is a workhorse drug.” — Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical developmentIn an Oct. 20 note to clients, Leerink Partners analysts said OptiTROP-Lung04 offered “exemplary outcomes” which support Merck and Kelun’s ambitions in the EGFR-mutant NSCLC indication.For its part, Merck is currently trying to replicate the China-only success in the global TroFuse-009 and TroFuse-004 trials.Green acknowledged that the global trials will be conducted under more diverse practices than the China-only study. EGFR-mutant NSCLC is more common in China than in Western populations, and doctors have gotten very good at treating the disease in the country, she said. In China, Kelun evaluated sac-TMT at a 5mg/kg dose, while Merck has selected 4mg/kg for the two global registrational trials, Leerink analysts noted. With the dose reduction, the team said it would expect “somewhat worse efficacy outcomes but an improved safety profile.”In TROP2 for second-line EGFR-mutant NSCLC, Merck is racing against AstraZeneca, whose Daiichi Sankyo-partnered Datroway is being paired with the British pharma’s Tagrisso in the Tropion-Lung15 trial, with a readout expected in the second half of 2026. HR-positive, HER2-negative breast cancer resultsIn the second positive phase 3 Kelun reported at ESMO 2025, sac-TMT significantly reduced the risk of progression or death by a massive 65% versus chemo in patients with previously treated HR-positive, HER2-negative breast cancer, according to results by blinded central review from the OptiTROP-Breast02 trial.The ADC more than doubled patients’ median PFS to 8.3 months, versus 4.1 months for chemo.The results were consistent across subgroups, including in those who were HER2 nil (effect size 61%) and HER2-low (69%), as well as in those who received one line of chemo in the advanced stage (65%) or more than one (63%). Patients in the study had all tried endocrine therapy, plus a CDK4/6 inhibitor and chemo.While OS data were not mature after a median follow-up of 7.4 months, data strongly favored sac-TMT with a preliminary 67% reduction in the risk of death. The incidence of grade 3 or above TRAEs was similar between the two groups, at 62% for sac-TMT and 64.8% for chemo. Stomatitis again stood out for sac-TMT with a 63% rate of any grade, versus 8% for chemo. The stomatitis cases were generally mild and manageable, Man Li from the Second Affiliated Hospital of Dalian Medical University said during her presentation of OptiTROP-Breast02.In previously treated HR+/HER2- breast cancer, AZ and Daiichi’s Datroway already won an FDA approval in January. Sac-TMT’s performance appears favorable to Datroway’s by cross-trial comparison.In Tropion-Breast01, Datroway reduced the risk of disease progression or death by 37% versus chemo. The median PFS was 6.9 months and 4.9 months for the two arms, respectively.The trial, however, did not meet its other dual primary endpoint, OS, with a hazard ratio of 1.01. Even after accounting for subsequent ADC use, the adjusted hazard ratio was 0.86, equating a 14% death risk reduction in favor of Datroway. The comparison should be viewed with caution, as the two trials populations are not identical, including their proportions of second-line and third-line patients.Again hoping to expand sac-TMT’s win in HR+/HER2- breast cancer to a global population, Merck is running the TroFuse-010 trial, testing the drug either by itself or in combination with Keytruda in patients who have not tried chemotherapy in the advanced stage.Competition there includes Gilead Sciences’ Ascent-07 trial for Trodelvy.Editor\'s Note: The story was updated Oct. 21 at 8 a.m. ET to include additional comments from a Leerink Partners note.

Clinical ResultPhase 3ADCDrug Approval

100 Deals associated with Amivantamab-VMJM

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R&D Status

Approved

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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.

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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
Colorectal Cancer	Phase 3	United States	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	China	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Japan	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Australia	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Belgium	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Brazil	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	France	Janssen Research & Development LLC	12 Dec 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05663866 (SKIPPirr, CTgov)	Phase 2	EGFR-mutated non-small Cell Lung Cancer	68	Dexamethasone (Cohort A: Dexamethasone 4 Milligrams (mg))	oxskvtfqkn = xzsvwvgbkc lyxsogpkeb (vnxgnrudnj, ngoaspnflu - dxfwoixpon)	-	20 Oct 2025
				Dexamethasone (Cohort A2: Dexamethasone 8 mg)	oxskvtfqkn = qgyqkmweja lyxsogpkeb (vnxgnrudnj, bibibrfffj - smifpyccnn) View more
NCT06385080 (OrigAMI-4, Company_Website \| ESMO2025) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck	86	amivantamab (SC) (efficacy-evaluable)	fawoaalujc(boesrwrrdi) = mdpwkbvjnd deeviiqhkb (yvoaczmzpi, 29 - 62) View more	Positive	19 Oct 2025
				amivantamab (SC) (safety-evaluable population)	jdqehbhxaf(zdqseufmbt) = fcijghvwfr hsjzrcozpr (faznuauvqi ) View more
NCT05498428 (PALOMA-2, ESMO2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR-mutant	77	Amivantamab SC + Carboplatin + Pemetrexed (EGFR-mutant (Ex19del/L858R) advanced NSCLC post-osimertinib)	riswgttiak(azfbpvkgvt) = pooryehbqf ceqospukgr (xkotkxrzqt ) View more	Positive	17 Oct 2025
NCT03767075 (Basket of Baskets, ESMO2025)	Phase 1	Solid tumor MET kinase domain mutations/fusion-genes \| MET-amplifications CNG ≥6 \| EGFR mutations	40	Amivantamab (MET-amplifications CNG ≥6)	gtnlutytai(eiffiepbll) = lyootfqlsk kwxfjekhiy (daozwrinva ) View more	Positive	17 Oct 2025
				Amivantamab (MET kinase domain mutations/fusion-genes)	sskajvweau(cvwnuckjwu) = zjpyjaeyww stydrszvut (msjfjgvbek )
NCT06385080 (OrigAMI-4, ESMO2025)	Phase 1/2	Recurrent Squamous Cell Carcinoma of the Head and Neck	32	Amivantamab	bebpnpwflc(twjkaohfew) = ombbwtlnjh tfpxjlybkc (yeyeztyfbu ) View more	Positive	17 Oct 2025
NCT06385080 (OrigAMI-4, ESMO2025)	Phase 1/2	Recurrent Squamous Cell Carcinoma of the Head and Neck	11	Amivantamab + Paclitaxel (HPV-unrelated R/M HNSCC + Prior PD-1/PD-L1 inhibitor progression)	liczjbpdsq(oqzmavmxxi) = only 1 pt (of 7 DLT-evaluable) experienced DLT (mucositis) mdzskuestr (xcjkeerybj ) View more	Positive	17 Oct 2025
NCT06667076 (COPERNICUS, ESMO2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutated	450	Amivantamab SC + Lazertinib	rnnzvtzurm(jkknqjzekg) = fhawoawtgm dnjvnpynzt (hbxnncboaa ) View more	Positive	17 Oct 2025
				Amivantamab SC + Carboplatin/Pemetrexed	yqjjzwwzjl(raoxkjjoiq) = cugzlrzxsu yoontnwcis (duejdpawww ) View more
ESMO2025	Not Applicable	Non-Small Cell Lung Cancer	12,820	Osimertinib	eaekwnumcs(unkjuxeyxk) = xpgylqolqx vyhrzuskep (kympnkwtdg, 0.7 - 1.4) View more	Positive	17 Oct 2025
				Alectinib	eaekwnumcs(unkjuxeyxk) = fcvixpudcg vyhrzuskep (kympnkwtdg, 0.2 - 0.6) View more
NCT04487080 (MARIPOSA, PRNewswire) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR L858R \| EGFR Exon 19 Deletion	1,074	埃万妥单抗+兰泽替尼	qujttbmawd(tnpkuqiuwf) = 化疗联合方案达到了预设最终次要终点 OS，并显示出相较于奥希替尼单药治疗具有统计学显著性以及临床意义上的改善。 ojaymraulq (ixtswpflaq ) Met View more	Positive	12 Sep 2025
				奥希替尼
NCT05498428 (PALOMA-2, WCLC2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation	77	LazertinibSubcutaneous Amivantamab Q4W + LazertinibSubcutaneous Amivantamab Q4W	hgiaolxvqb(paplzdwbjz) = yczqygtxkb wddgwbkrmu (pwfaybzjsm )	Positive	09 Sep 2025

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