RegulationAccelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (United States), Breakthrough Therapy (United States)

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

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

NCT06816992

/ RecruitingPhase 1

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

Start Date27 Feb 2025

Sponsor / Collaborator

Oric Pharmaceuticals, Inc.

[+1]

CTR20244582

/ RecruitingPhase 3

一项在左侧、不可切除或转移性KRAS/NRAS和BRAF野生型结直肠癌受试者中比较Amivantamab或西妥昔单抗与mFOLFOX6或FOLFIRI联合治疗作为一线治疗的随机、开放性、III期研究

[Translation] A randomized, open-label, phase III study comparing amivantamab or cetuximab in combination with mFOLFOX6 or FOLFIRI as first-line treatment in subjects with left-sided, unresectable or metastatic KRAS/NRAS and BRAF wild-type colorectal cancer

本研究的主要目的是在左侧、不可切除或转移性KRAS/NRAS和BRAF WT结直肠癌受试者中比较接受Amivantamab＋mFOLFOX6或FOLFIRI治疗与接受西妥昔单抗＋mFOLFOX6或FOLFIRI治疗的无进展生存期

[Translation]

The primary objective of this study was to compare progression-free survival between patients treated with amivantamab plus mFOLFOX6 or FOLFIRI and those treated with cetuximab plus mFOLFOX6 or FOLFIRI in patients with left-sided, unresectable or metastatic KRAS/NRAS and BRAF WT colorectal cancer.

Start Date16 Jan 2025

Sponsor / Collaborator

Johnson & Johnson (China) Investment Ltd.

[+4]

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

169

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 Apr 2025·CLINICAL ONCOLOGY

Comparing the Effectiveness and Safety of First-line Interventions in Patients With Advanced Epidermal Growth Factor Receptor-mutant Non-small Cell Lung Cancer, With Particular Focus on Brain Metastatic Status: A Systematic Review and Network Meta-analysis

Review

Author: Wang, T ; Mei, T ; Zhou, Q ; Xu, T

AIMS:

This network meta-analysis (NMA) aimed to identify the most effective first-line intervention (FLI) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), particularly in patients with varying brain metastasis (BM) status.

MATERIALS AND METHODS:

Data were collected from randomized controlled trials (RCTs) evaluating first-line EGFR-tyrosine kinase inhibitors (EGFR-TKIs), either alone or in combination, for EGFR-mutated advanced NSCLC (EMAN) patients. The sources included EMBASE, Web of Science, Cochrane Library, PubMed, and relevant conference abstracts from inception until December 2023.

RESULTS:

A total of 37 RCTs, encompassing 24 intervention options, were included in the NMA. Osimertinib combined with chemotherapy (CT) significantly improved progression-free survival (PFS) compared to aumolertinib (HR, 0.61; 95% CI, 0.40-0.93), furmonertinib (HR, 0.64; 95% CI, 0.41-0.98), lazertinib (HR, 0.64; 95% CI, 0.41-0.98), osimertinib alone (HR, 0.62; 95% CI, 0.48-0.80), osimertinib + bevacizumab (HR, 0.72; 95% CI, 0.51-1.00), befotertinib (HR, 0.57; 95% CI, 0.36-0.90), and zorifertinib (HR, 0.61; 95% CI, 0.39-0.93). Further, amivantamab + lazertinib showed slightly better PFS compared to aumolertinib, furmonertinib, zorifertinib, and osimertinib + bevacizumab (HR <1, but P >0.05). Regarding overall survival (OS), amivantamab + lazertinib demonstrated superior results relative to furmonertinib (HR, 0.54; 95% CI, 0.30-0.95) and befotertinib (HR, 0.43; 95% CI, 0.24-0.77). No significant OS differences were observed among osimertinib, osimertinib + bevacizumab, osimertinib + CT, lazertinib, and amivantamab + lazertinib. In BM patients, osimertinib + CT significantly enhanced PFS compared to osimertinib (HR, 0.47; 95% CI, 0.33-0.66), furmonertinib (HR, 0.44; 95% CI, 0.21-0.90), befotertinib (HR, 0.45; 95% CI, 0.21-1.00), and zorifertinib (HR, 0.47; 95% CI, 0.25-0.89). However, no noticeable PFS differences were observed between osimertinib + CT and amivantamab + lazertinib or aumolertinib. Lastly, osimertinib + CT and zorifertinib were associated with higher rates of all-grade adverse events (AEs) and grade ≥3 AEs, respectively.

CONCLUSIONS:

In EMAN patients, osimertinib + CT and amivantamab + lazertinib were associated with optimal PFS and OS, respectively. Among BM patients, osimertinib + CT offered the best PFS benefits. These findings may assist in clinical decision-making and personalized care for EMAN and BM patients. The study is registered on PROSPERO (CRD42024506995).

28 Mar 2025·Journal of the National Comprehensive Cancer Network

HSR25-187: Meta-Analysis of Phase III Randomized Controlled Trials to Evaluate the Risk of Gastrointestinal Adverse Events in Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) Treated With Amivantamab

Article

Author: Aboaid, Hazem ; Schlesinger, Tal ; Thein, Kyaw Zin ; Hussain, Abbas ; Hattin, Riccesha ; Jones, Daniel Thomas ; Lambert-Swainston, Chalette ; Aharonian, Karl ; Srinivasmurthy, Ramaditya ; Schauer, Savannah ; Rahmani, Rodd ; Parto, Ryan ; Twells, Rory

244

News (Medical) associated with Amivantamab-VMJM

07 Apr 2025

·pipelinereview.com

European Commission approves subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer

Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation 1 European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study 1 BEERSE, Belgium I April 07, 2025 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT ® (amivantamab), in combination with LAZCLUZE ® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards. 1 This approval follows the recent presentation of final overall survival (OS) results from the Phase 3 MARIPOSA study ( NCT04487080 ), at the 2025 European Lung Cancer Congress (ELCC), showing statistically superior OS with intravenous (IV) amivantamab plus lazertinib versus osimertinib monotherapy in the first-line treatment of patients with advanced EGFR ex19del or L858R substitution mutated NSCLC (hazard ratio [HR], 0.75; 95 percent Confidence Interval [CI], 0.61-0.92; P<0.005). 2 “While great strides have been made in the treatment of EGFR-mutated non-small cell lung cancer, a critical need still exists for treatment approaches that are not only effective but also more convenient for patients, while optimising experience in the clinic,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy.* “The approval of subcutaneous amivantamab will have a meaningful impact on clinical practice, offering patients greater convenience and an improved treatment experience, without compromising on the well-established efficacy of intravenous amivantamab.” The EC approval is supported by positive results from the Phase 3 PALOMA-3 study ( NCT05388669 ), which evaluated non-inferiority of pharmacokinetics (PK) in addition to efficacy and safety of SC amivantamab (administered via manual injection) compared to IV amivantamab (the already approved route of administration), both in combination with lazertinib, in patients with EGFR-mutated advanced or metastatic NSCLC after disease progression on osimertinib and platinum-based chemotherapy. 1,3 The study demonstrated that SC amivantamab was non-inferior to IV amivantamab, meeting both co-primary PK endpoints as measured by amivantamab levels in the blood (C trough and area under the serum concentration time curve from Cycle 2 day 1 to 15). 1 At a median follow-up of 7 months, the overall response rate (a secondary endpoint) was 30 percent (95 percent confidence interval [CI], 24–37) in the SC arm and 33 percent (95 percent CI, 26–39) for IV (relative risk, 0.92; 95 percent CI, 0.70–1.23; P =0.001), meeting the non-inferiority criteria. 1 Administration time for SC amivantamab was approximately five minutes, and results showed a five-fold reduction in infusion-related reactions (IRRs) compared to IV administration. 1 These results were featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology . 1,4 “The approval of subcutaneous amivantamab represents a welcome improvement of the treatment experience for both patients living with EGFR-mutated advanced non-small cell lung cancer and the healthcare professionals who support them,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “This advancement presents an important opportunity to reduce the treatment burden, improve quality of life and give patients more time to focus on what truly matters to them.” The rate of IRRs for patients treated with SC amivantamab combined with lazertinib was shown to be approximately five-fold lower than that observed with the IV formulation (13 percent vs 66 percent, respectively). 1 The majority of IRRs were grades 1 and 2, with one patient experiencing a grade 3 IRR in the SC arm. 1 Preventive blood thinning (prophylactic anticoagulation) was used in most patients in the PALOMA-3 study. 1 Patients receiving prophylactic anticoagulation had lower rates of venous thromboembolic events (VTEs) (10 percent) than those who did not receive prophylaxis (21 percent). 1 Furthermore, VTE incidence was numerically lower in the SC arm vs the IV arm (9 percent vs 14 percent) regardless of anticoagulation status. 1 Severe bleeding risk (grade 3 to 4) was low among patients receiving anticoagulants in both the SC (2 percent) and IV (0.6 percent) arms. 1 Otherwise, the overall safety profile of SC amivantamab is consistent with the known profile of IV administration. 1 The most common all-grade adverse events of any cause that occurred for SC amivantamab compared to IV, were paronychia (54 percent vs 51 percent), hypoalbuminaemia (47 percent vs 37 percent) and rash (46 percent vs 43 percent), respectively. 1 “At Johnson & Johnson, we are dedicated to patient-centered innovation in our mission to address the critical unmet needs in lung cancer treatment and care,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “Our ongoing focus on advancing the clinical development programme for amivantamab reflects our confidence in its potential to become a standard of care for EGFR-and MET-driven lung cancer.” #ENDS# About Amivantamab Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system. 5,6,7,8 The European Commission (EC) has approved amivantamab in the following indications: 8 Intravenous amivantamab: Subcutaneous amivantamab: The recommended dose regimen for SC amivantamab for these indications is 1600 mg (2240 mg for body weight ≥80kg) administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards (Q2W). 8 When given in combination with lazertinib, it is recommended to administer SC amivantamab any time after lazertinib when given on the same day. 8 Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE ® drug delivery technology. 1 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics . 8 ▼ In line with EMA regulations for new medicines, amivantamab is subject to additional monitoring. About Lazertinib In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. 9 An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023. 9 In January 2025, the European Commission EC approved a marketing authorisation for lazertinib, in combination with amivantamab, for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations. 10 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using lazertinib, please refer to the Summary of Product Characteristics . 11 ▼ In line with EMA regulations for new medicines, lazertinib is subject to additional monitoring. About PALOMA-3 PALOMA-3 ( NCT05388669 ), which enrolled 418 patients, is a randomised, open-label Phase 3 study evaluating the non-inferiority of pharmacokinetics (PK), efficacy and safety of subcutaneous amivantamab (administered via manual injection) combined with lazertinib compared to IV amivantamab and lazertinib in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and platinum-based chemotherapy. 1 The co-primary PK endpoints of the study were trough concentration (C trough on Cycle [C] 2 Day [D] 1 or C4D1) and C2 area under the curve (AUCD1-D15). 1 Key secondary endpoints were objective response rate (ORR) and progression-free survival (PFS). 1 Overall survival was a predefined exploratory endpoint. 1 Prophylactic anticoagulation was recommended for the first four months of treatment. 1 About Non-Small Cell Lung Cancer In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022. 12 NSCLC accounts for 85 percent of all lung cancer cases. 13 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined. 12 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. 13 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division. 13,14 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients. 15,16,17,18 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations. 19 The five-year survival rate for all patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment. 20,21,22,23,24,25,26 EGFR exon 20 insertion (ex20ins) mutations are the third most prevalent activating EGFR mutation. 27 Patients with EGFR ex20ins mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent. 21 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://innovativemedicine.jnj.com/emea/ . Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies. References 1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology . 2024;42(3):3593-3605. 2 Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line (1L) EGFR-mutant (EGFRm) Advanced NSCLC: Final Overall Survival (OS) from the Phase 3 MARIPOSA Study. 2025 European Lung Cancer Congress. March 26, 2025. 3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). https://clinicaltrials.gov/ct2/show/NCT05388669 . Accessed April 2025. 4 Leighl N, et al. Subcutaneous Amivantamab Plus Lazertinib Vs Intravenous Amivantamab Plus Lazertinib In EGFR-mutated, Advanced Non-small Cell Lung Cancer (NSCLC): PALOMA-3, A Phase 3, Global, Randomized, Controlled Trial. 2024 American Society of Clinical Oncology Annual Meeting. May 31, 2024. 5 Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res 2016;76(13)(suppl 27216193):3942-3953. 6 Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs . 2017;9(1):114-126. 7 Yun J, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov . 2020;10(8):1194-1209. 8 European Medicines Agency. Amivantamab Summary of Product Characteristics. January 2025. Available at: https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf . Accessed: April 2025. 9 Cho, BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR -mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217. 10 Innovativemedicine.jnj.com/EMEA. European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer . Accessed: April 2025 11 European Medicines Agency. Lazcluze. January 2025. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze . Accessed April 2025. 12 Global Cancer Observatory. Cancer Today. Available at: https://gco.iarc.fr/en . Accessed April 2025. 13 Zappa C, et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res . 2016;5(3):288–300. 14 Wee P, Wang Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers. 2017;9(5):52. 15 Pennell NA, et al. A phase II trial pf adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol . 2019;37(7);97-104. 16 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 17 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget . 2016;7(48):78985-78993. 18 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res . 2015;5(9):2892-2911. 19 American Lung Association. EGFR and Lung Cancer. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr . Accessed April 2025. 20 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol 2016 Apr;11(4):556-65. 21 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 22 Shao J et al. The number of brain metastases predicts the survival of non-small cell lung cancer patients with EGFRR mutation status. Cancer Rep (Hoboken). 2022;5(9): e1550. 23 Achrol A et al. Brain metastases. Nat Rev Dis Primers . 2019;17(5): 5. 24 Rangachari D et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer . 2015;88(1): 108-111. 25 Nieva J, et al. A real-world (rw) observational study of long-term survival (LTS) and treatment patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC). Ann Oncol . 2023;34, S774. 26 Girard N, Leighl NB, Ohe Y, et al. Mortality among EGFR-mutated advanced NSCLC patients after starting frontline osimertinib treatment: a real-world, US attrition analysis. Presented at: the European Lung Cancer Congress; March 29-April 1, 2023; Copenhagen, Denmark. Poster 19P. 27 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9. SOURCE: Johnson & Johnson

Clinical ResultPhase 3ASCODrug ApprovalLicense out/in

07 Apr 2025

·www.prnewswire.com

European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE® drug delivery technology. "We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system." The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.1 1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and infusion related reactions and broadening the treatment options for the indications referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3

28 Mar 2025

·www.fiercepharma.com

Fierce Pharma Asia—Novo's triple G obesity bet; Merck's latest China deal; Hengrui, Elevar's 2nd FDA snub

Novo Nordisk's China obesity deal, Merck's cardiovascular licensing deal, and an FDA rejection for Hengrui and Elevar's PD-1 combo made our news this week. Novo Nordisk snapped up an obesity asset from China's United Laboratories in a deal worth up to $2 billion. Merck & Co. got a lipoprotein(a) inhibitor from Jiangsu Hengrui Pharma for cardiovascular disease. Hengrui and Elevar Therapeutics' PD-1 liver cancer combination was again tripped up by manufacturing at the FDA.1. Novo Nordisk pens $2B deal for triple G agonist tied to 15% weight loss at 12 weeksNovo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion. The candidate, coded UBT251, would be a direct competitor to Eli Lilly’s retatrutide. In a phase 1b trial, weekly UBT251 at the highest subcutaneous dose of 6 mg led to an average 15.1% weight loss from baseline after 12 weeks.2. Merck & Co. pens $200M upfront deal for Hengrui's midstage heart disease medIn another China deal potentially worth up to $2 billion, Merck & Co. is paying $200 million upfront for a phase 2 lipoprotein(a) inhibitor from Hengrui Pharma. Elevated Lp(a) in the blood, as a risk factor for cardiovascular disease, has become an increasingly popular target. Lilly has a clinical candidate called muvalaplin, and AstraZeneca last year licensed a preclinical one from China’s CSPC Pharma.3. FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—againIn a piece of bad news for Hengrui, the FDA has once again rejected its Elevar Therapeutics-partnered combination of the PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib. Like the first rejection last year, the FDA this time also raised problems with Hengrui’s camrelizumab manufacturing facility in China.4. AbbVie takes Genmab to court, accusing partner of being 'willfully blind' to ADC trade secret theftAbbVie has sued Genmab over the Danish company’s $1.8 billion acquisition of Sino-American biotech ProfoundBio last year. The Illinois pharma alleged that Genmab was “intentionally and willfully blind” to Profound’s alleged theft of its antibody-drug conjugate trade secrets. Genmab said it “categorically refutes allegations and will vigorously defend the company.”5. J&J combo signals new era in EGFR lung cancer with survival win against AstraZeneca's TagrissoJohnson & Johnson’s Rybrevant and its Yuhan-partnered Lazcluze significantly reduced the risk of death by 25% versus AstraZeneca’s Tagrisso in first-line EGFR-mutated non-small cell lung cancer, according to a high-stakes readout from the phase 3 Mariposa trial. J&J believes the overall survival win sets the combo up to be the new standard of care. But the high-maintenance nature of the regimen poses a challenge.6. Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO surveyTrump again threatens tariffs on pharmaceuticals in 'not too distant' futurePresident Donald Trump said his administration will announce tariffs on pharmaceuticals “in the not too distant” future. But in a recent survey conducted by the Biotechnology Innovation Organization, a large proportion of biopharma companies polled said tariffs on EU, Canada or China will drive up manufacturing costs. Many respondents also fear that tariffs could disrupt R&D and regulatory plans.7. FDA calls out 'particularly concerning' claims on HCP site for Taiho's LytgobiThe FDA has taken issue with Taiho Oncology’s doctor-facing web page for the cholangiocarcinoma drug Lytgobi. The agency raised concerns that some descriptions of the drug’s overall survival and progression-free survival data from a single-arm phase 2 study were misleading. The agency is giving the firm 15 working days to submit a written response.8. Eisai lays out road map to blockbuster sales projections for Leqembi's 'milestone' 2027 year9. Contractors WuXi Bio, WuXi XDC eye continued growth after logging solid performances in 202410. Gavi terminates COVID vaccine deal with Clover, demands $224M repayment11. Ascletis slashes funding for former core programs in pivot to obesity12. ImmuneOnco axes CD47 bispecific as pipeline prioritization pressures hit Chinese biotech13. India's Aspen Biopharma Labs hit with FDA warning letter citing infrastructure, contamination and records problems14. Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO15. Bharat Biotech enters cell and gene therapy market with $75M production investment: reports16. Bayer gains Puhe’s cancer drug candidate in another China deal (release)17. Kaken agrees to $180M deal to develop Alumis' lead TYK2 inhibitor in Japan

VaccinePhase 2Phase 1Clinical ResultPhase 3

100 Deals associated with Amivantamab-VMJM

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KEGG	Wiki	ATC	Drug Bank
-	Amivantamab-VMJM	L01	-

R&D Status

Approved

10 top approved records.

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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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
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	Shanghai Johnson & Johnson Pharmaceutical Ltd.	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Cilag AG	26 Jan 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	United States	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	China	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Japan	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Australia	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Belgium	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Brazil	Janssen Research & Development LLC	12 Dec 2024
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	France	Janssen Research & Development LLC	12 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06120140 (COCOON, ESMO_ELCC2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line Ex19del/L858R	200	amivantamab (Enhanced Dermatologic Management (COCOON DM))	ipmoyaateb(pbsunteatc) = htwfqskiwk exjctuafsg (ejcmvbxfdm ) View more	Positive	27 Mar 2025
				amivantamab (Standard of Care Dermatologic Management (SoC DM))	ipmoyaateb(pbsunteatc) = whnaiysqho exjctuafsg (ejcmvbxfdm ) View more
NCT04077463 (CHRYSALIS-2, ESMO_ELCC2025) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	49	Amivantamab plus Lazertinib	fvkkejzzsd(tlpeoiytty) = lhhfkzikza xtcfpszvrc (pyiancnejq ) View more	Positive	26 Mar 2025
				EGFR TKIs (Osimertinib, Afatinib)	fvkkejzzsd(tlpeoiytty) = uvdciciyrt xtcfpszvrc (pyiancnejq ) View more
NCT04487080 (MARIPOSA, ESMO_ELCC2025) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR L858R \| EGFR Exon 19 Deletion	-	Amivantamab plus Lazertinib	fhxavipdkl(yrucausdum) = gnvxabvhbi qbbnmmhxrk (ekrrbltpps, 42.9 - NE) View more	Positive	26 Mar 2025
				Osimertinib	fhxavipdkl(yrucausdum) = cxspxmccof qbbnmmhxrk (ekrrbltpps, 33.4 - 41.0) View more
ATLAS (ESMO_ELCC2025)	Not Applicable	EGFR Exon 20 insertion mutations	64	Amivantamab	immvhlfzoz(vnazfrgknu) = 53.1% with G33 in 7.8% ogtuuoazrb (kuuytoqrbe ) View more	Positive	26 Mar 2025
NCT05498428 (PALOMA-2, ESMO_ELCC2025)	Phase 2	Non-Small Cell Lung Cancer EGFRm \| MET-related	25	IV Amivantamab	unnjkcywtz(fkfzrxlght) = Most adverse events (AEs) were EGFR/MET-related and grade 1-2. Most common AEs were paronychia (44%; gr≥3: 4%), rash-related (40%; gr≥3: 12%), and hypoalbuminemia (40%; gr≥3: 4%). No ARRs were reported; 1 pt discontinued ami due to a treatment-related AE (interstitial lung disease) isecgfzcrr (fjzwpmjaaw ) View more	Positive	26 Mar 2025
				SC Amivantamab
NCT05379595 (OrigAMI-1, ASCO_GI2025) Manual	Phase 1/2	Metastatic Colorectal Carcinoma	30	Amivantamab monotherapy	nqbqtlnopu(pubivihkmr) = uuwefmtjwm urssvfszod (igrxpfmdtk, 56 - 93) View more	Positive	23 Jan 2025
				Amivantamab + FOLFOX or FOLFIRI	nqbqtlnopu(pubivihkmr) = ciullzmstx urssvfszod (igrxpfmdtk, 42 - 100) View more
NCT04487080 (MARIPOSA, Company_Website) Manual	Phase 3	Non-Small Cell Lung Cancer First line EGFR Exon 19 Deletion \| EGFR L858R	1,074	RYBREVANT+LAZCLUZE	qzrnyunblk(vauxxeodln) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. zxoyybibni (iszaycvsyv ) Met	Positive	07 Jan 2025
				osimertinib
NCT04077463 (CHRYSALIS-2, Pubmed) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR L858R \| EGFR Exon 19 Deletion	162	Amivantamab 1050 mg + Lazertinib 240 mg	djshstqhhv(abrmaclvwm) = egzbqzznzc sirinfgxvi (hldmfcpppo, 22 - 36) View more	Positive	02 Jan 2025
NCT02609776 (CHRYSALIS, ESMO_ASIA2024) Manual	Not Applicable	Non-Small Cell Lung Cancer EGFR Exon 20 Insertion	114	Amivantamab	naqzdfyfcv(aaykywkazd) = ugykvuvikv siqxvsthfj (ncakuzpobn ) View more	Positive	07 Dec 2024
				External control（Taiwan real-world setting）	naqzdfyfcv(aaykywkazd) = hytgahkxgg siqxvsthfj (ncakuzpobn ) View more
NCT05653427 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	18	Amivantamab	rmmyjgsnrp = beqwmejoab gdlubtubuz (girddhokkl, cgjxeyyvjo - xivkevfvwp) View more	-	30 Oct 2024

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