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 Date17 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

295

Literatures (Medical) associated with Amivantamab-VMJM

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

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

Article

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

OBJECTIVES:

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

METHODS:

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

RESULTS:

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

LIMITATIONS:

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

CONCLUSIONS:

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

01 Aug 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Immunotherapeutic strategies in HPV-positive and HPV-negative recurrent/metastatic oropharyngeal squamous cell carcinoma: From PD-1 blockade to EGFR-directed bispecifics and therapeutic HPV vaccines

Review

Author: Del Mastro, Lucia ; Gili, Riccardo ; Di Bello, Armando ; Caterino, Marianna ; Cassano, Alessandra ; Bassolino, Antonio ; Fasano, Morena ; Polidori, Sara ; Falcicchia, Renato ; Tortora, Giampaolo

Oropharyngeal squamous cell carcinoma (OPSCC) comprises two biologically distinct entities, HPV-positive and HPV-negative disease, which differ in etiology, immune microenvironment, molecular drivers, and clinical behavior. This narrative review summarizes current evidence on immunotherapeutic strategies in OPSCC, focusing on subtype-specific biological rationale and emerging treatment approaches. A literature search of PubMed/MEDLINE, Embase, Cochrane Library, ClinicalTrials.gov, and major oncology meeting abstracts was conducted for studies published from January 2000 to February 2026. PD-1/PD-L1 inhibitors represent the current standard of care in recurrent/metastatic disease, with HPV-positive tumors generally showing more favorable outcomes, likely reflecting a more inflamed and antigen-rich tumor microenvironment. However, HPV status remains primarily a prognostic rather than a validated predictive biomarker for checkpoint inhibitor benefit. In contrast, HPV-negative OPSCC is more frequently characterized by immune exclusion, EGFR dependence, hypoxia, and activation of MET/HGF and TGF-β pathways, supporting the development of EGFR-centered and bifunctional strategies to overcome resistance. Emerging agents such as ficerafusp alfa, petosemtamab, and amivantamab have demonstrated promising early clinical activity, particularly in biomarker-enriched or post-immunotherapy settings. In HPV-positive disease, therapeutic vaccines targeting E6/E7 oncoproteins have shown encouraging immunogenicity and preliminary antitumor activity, especially when combined with PD-1 blockade. Overall, the immunotherapeutic landscape of OPSCC is evolving toward a biomarker-driven framework integrating viral status, immune contexture and pathway activation to enable more precise and personalized treatment strategies.

01 Jun 2026·LUNG CANCER

Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer

Review

Author: Tseng, Jeng-Sen ; Li, Molly ; Simoes, Jairo ; Voon, Pei Jye ; Tanizaki, Junko ; Hasegawa, Kazuo ; Fernandez-Penas, Pablo ; Pavlakis, Nick ; Tan, Chris ; Parkinson, Nicole ; Kam, Julian ; Lu, Shun ; Dong, Xiao Rong ; Soo, Ross A ; Kim, Hye Ryun ; McGeachie, Marija ; Prabhash, Kumar

Amivantamab, an epidermal growth factor receptor (EGFR)-MET bispecific antibody, has demonstrated clinically meaningful benefits for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). Consistent with EGFR and MET inhibition, amivantamab-containing regimens are associated with adverse events (AEs) including dermatologic AEs, edema, hypoalbuminemia, venous thromboembolism (VTE), and infusion-related reactions (IRRs). Here we provide practical consensus guidelines developed by a steering committee of 12 clinicians and supported by a literature review of current clinical recommendations, in addition to interviews with representatives of 2 patient advocacy groups, on managing the safety profile of amivantamab-containing regimens for clinicians in the Asia-Pacific (APAC) region. Consensus clinical guidelines recommend prophylactic anticoagulants, minocycline/doxycycline, and moisturizers as key management of common AEs associated with amivantamab, with detailed guidance provided for reactive management across AE grades. Guidance was based on published supportive care strategies for amivantamab and previous evidence on managing EGFR and MET tyrosine kinase inhibitor-related AEs. Prophylactic strategies and reactive treatments were summarized for skin-related AEs, paronychia, mucositis, and stomatitis. Recommendations for preventing and treating MET-related AEs, VTEs, and IRRs were also provided. Multidisciplinary team involvement in early intervention and management of AEs was encouraged. Patient advocacy groups advised clinicians to clearly explain the rationale for prophylactic and reactive treatments and to educate patients on how to appropriately and most efficiently utilize daily supportive care. Appropriate strategies based on these guidelines are encouraged and achievable for APAC clinicians to improve patient care during treatment with amivantamab-containing regimens.

358

News (Medical) associated with Amivantamab-VMJM

06 Jun 2026

·www.prnewswire.com

RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer

Median overall survival, a secondary endpoint, reached nearly 3.5 years with Johnson & Johnson's RYBREVANT® plus LAZCLUZE® in atypical EGFR-mutated disease Consistent responses observed across atypical EGFR mutation subgroups, including those historically associated with poorer outcomes ASCO 2026 results reinforce the significance of RYBREVANT®-based regimens for patients across EGFR mutations May 29, 2026 -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 1/1b CHRYSALIS-2 study evaluating intravenous RYBREVANT® (amivantamab-vmjw) in combination with LAZCLUZE® (lazertinib) in patients with advanced non-small cell lung cancer (NSCLC) with atypical epidermal growth factor receptor (EGFR) mutations. The analysis showed encouraging long-term outcomes with RYBREVANT® plus LAZCLUZE® in this difficult-to-treat population. Median overall survival, a secondary endpoint, was nearly 3.5 years.1 The primary endpoint of objective response rate was previously reported.2 These results add to the growing body of evidence demonstrating the potential of RYBREVANT® plus LAZCLUZE® to deliver durable survival outcomes across both common and atypical EGFR-mutated advanced NSCLC in the first-line setting. Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8501).1 Patients with atypical EGFR-mutated NSCLC tend to have poorer outcomes than those with common EGFR mutations (exon 19 deletions and L858R substitutions), and effective first-line treatment options remain limited.3,4 These mutations represent approximately 10-20 percent of all EGFR-mutated cases.5 Median overall survival with current standard of care single-agent therapies remains under two years, highlighting a significant unmet need for treatments that can deliver more durable benefit in this setting.6,7 RYBREVANT® is designed to dual target EGFR and mesenchymal-epithelial transition (MET), while engaging the immune system.8,9,10,11 These complementary mechanisms play a central role in tumor growth and treatment resistance and may help address the underlying drivers of disease. "For patients with non-small cell lung cancer harboring atypical EGFR-mutations, first-line treatment decisions are often clouded by uncertainty regarding the efficacy of currently available EGFR tyrosine kinase inhibitors," said Joel Neal,* M.D., Ph.D., principal investigator of the Phase 1/1b CHRYSALIS-2 study. "The responses we've seen in this trial suggest the potential for more durable disease control, and the overall survival data reinforce that picture. These long-term outcomes begin to change how we think about treatment options in managing this subtype of lung cancer." Neal is also a Professor of Medicine in the Division of Oncology at Stanford Medicine. "Disease progression and molecular resistance remain critical barriers in EGFR-mutated non-small cell lung cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "RYBREVANT-based combinations demonstrate the power of changing the biology by addressing multiple disease drivers from the start rather than relying on single-pathway strategies. With strong outcomes across all known EGFR mutations, this approach is raising the bar for what first-line treatment can achieve." In Cohort C of the CHRYSALIS-2 study, RYBREVANT® plus LAZCLUZE® was evaluated as a first-line treatment in patients with atypical EGFR-mutated advanced NSCLC, excluding EGFR exon 20 insertion mutations (n=49). The most common atypical EGFR mutations included G719X (55 percent), S768X (27 percent) and L861X (24 percent), with 35 percent of patients harboring multiple atypical mutations. The study previously reported an objective response rate of 57 percent (primary endpoint).1,2 Median overall survival with RYBREVANT® plus LAZCLUZE® reached nearly 3.5 years (41.0 months; 95 percent confidence interval [CI], 27.7-not estimable) at a median follow-up of 31.3 months. Overall survival rates were 55 percent at three years and 46 percent at four years.1 Consistent clinical activity was observed across atypical EGFR mutation subgroups, as well as across patient and disease characteristics such as central nervous system metastases and TP53 status. Patients were also able to remain on treatment long-term across mutation groups and baseline characteristics. Notably, 41 percent of patients remained on RYBREVANT® for two years or longer, further supporting the durable survival observed with this combination.1 The safety profile of RYBREVANT® plus LAZCLUZE® was consistent with previous reports, with no new safety signals observed with longer follow-up. Most adverse events were Grade 1 or 2. The most common treatment-emergent adverse events occurring in more than 30 percent of patients included paronychia (78 percent), rash (65 percent), hypoalbuminemia (61 percent) and infusion-related reactions (61 percent).1 RYBREVANT®-based regimens are approved for patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, including in the first-line setting.12 These results further define long-term outcomes with first-line RYBREVANT® plus LAZCLUZE® for patients with atypical EGFR mutations. Additional data being presented at ASCO 2026 in lung, head and neck, and colorectal cancers underscore the broader potential of RYBREVANT® across tumor types. CHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and pharmacokinetics of LAZCLUZE®, a third-generation EGFR-TKI, as monotherapy or in combinations with RYBREVANT®, a human bispecific EGFR and cMet antibody in participants with advanced NSCLC. The study enrolled 460 patients with advanced NSCLC.13 Cohort C of the ongoing CHRYSALIS-2 study evaluates patients with atypical EGFR-mutated advanced NSCLC, excluding exon 20 insertion and classical EGFR mutations, who are treatment-naïve or have received up to two prior lines of therapy. Patients received intravenous RYBREVANT® in combination with LAZCLUZE® administered orally once daily.13 Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.14,15 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.16 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17 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.14,15,18,19,20,21 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.22 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.23,24 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.25 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (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.26 RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly† or bi-weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. RYBREVANT® (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO™ across multiple markets. RYBERVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system. The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC. The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 27 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ || The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases. Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers. In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE® (marketed as LECLAZA in South Korea). LAZCLUZE® is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE® from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.28 The legal manufacturer for LAZCLUZE® is Janssen Biotech, Inc. and Yuhan Corporation.INDICATIONS 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. Source: Johnson & Johnson 1 Neal JW, et al. Overall survival of first-line amivantamab plus lazertinib in atypical EGFR-mutated advanced NSCLC: Updated results from the CHRYSALIS-2 study. Presented at: 2026 ASCO Annual Meeting; 2026; Chicago, IL. 2 Tomasini P, Wang Y, Li Y, et al. Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. J Clin Oncol. 2026;44(1):54-65. doi:10.1200/JCO-24-02835 3 Kim EY, Cho EN, Park HS, et al. Compound EGFR mutation is frequently detected with co-mutations of actionable genes and associated with poor clinical outcome in lung adenocarcinoma. Cancer Biol Ther. 2016;17(3):237-245. doi:10.1080/15384047.2016.1139235 4 Patil T, Mushtaq R, Marsh S, et al. Clinicopathologic characteristics, treatment outcomes, and acquired resistance patterns of atypical EGFR mutations and HER2 alterations in stage IV non-small-cell lung cancer. Clin Lung Cancer. 2020;21(3):e191-e204. doi:10.1016/j.cllc.2019.11.008 5 Fabrizio FP, Attili I, de Marinis F. Uncommon and Rare EGFR Mutations in Non-Small Cell Lung Cancer Patients with a Focus on Exon 20 Insertions and the Phase 3 PAPILLON Trial: The State of the Art. Cancers. 2024; 16(7):1331. https://doi.org/10.3390/cancers16071331 6 Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. doi:10.1016/S1470-2045(15)00026-1 7 GILOTRIF® (afatinib tablets), for oral use [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc.; 2022. 8 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833 9 Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071 10 Yun J, Lee SH, Kim SY, 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. doi:10.1158/2159-8290.CD-20-0116 11 Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6. 12 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 13 ClinicalTrials.gov. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed May 2026. 14 The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed May 2026. 15 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed May 2026. 16 Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18. 17 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 18 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 37:97-104. 19 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. 20 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. 21 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. 22 American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed May 2026. 23 Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site. 24 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. 25 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. 26 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. 27 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed May 2026. 28 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. 29 LAZCLUZE® Prescribing Information. Horsham, PA: Janssen Biotech, Inc. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalLicense out/inASCO

03 Jun 2026

·www.fiercepharma.com

As Akeso takes center stage at ASCO, China biotech industry cements its coming of age

Above the scientific discussions and deal talks at ASCO 2026, the dark cloud of geopolitics hovered over the Chicago convention center. In 2017, a little-known company called Nanjing Legend Biotech walked into the ASCO annual meeting at the 11th hour, dropped a 100% objective response rate for a cell therapy that would become Carvykti, and single-handedly put Chinese biotech on the global map. Nearly a decade later, taking the center stage at ASCO 2026, Akeso’s ivonescimab made history by offering the first-ever Chinese data set to command a coveted spot on the plenary session.“We see a lot of sophistication and skill in Chinese companies,” Marjorie Green, M.D., head of oncology global clinical development at Merck Research Laboratories, said in an interview.The maturity of the Chinese biopharma industry is evidenced by the deals it has signed. Through a potential $3.3 billion pact in 2024, Merck secured global rights to a PD-1xVEGF competitor to ivonescimab from China’s LaNova Medicines. The following year, LaNova was acquired by Sino Biopharm in the first full acquisition of an innovative Chinese biotech by a domestic large pharma on record, a milestone widely viewed as evidence of an increasingly mature ecosystem. At ASCO, ivonescimab’s landmark overall survival (OS) win against a PD-1 inhibitor in their respective combinations with chemotherapy in first-line squamous non-small cell lung cancer (NSCLC) was just one of numerous studies of Chinese assets that reshaped the conference’s narrative.In what Natalie Vokes, M.D., of the MD Anderson Cancer Center said “could well be a practice-changing study” if validated in a global trial, Kelun-Biotech’s TROP2 antibody-drug conjugate, sac-TMT, paired with Keytruda, slashed the risk of progression or death by 65% versus Keytruda alone in Chinese patients with previously untreated PD-L1-positive NSCLC. That drug, too, also has been swept into the Merck universe.Even though the study used Keytruda monotherapy as the comparator, Vokes noted on stage that the progression-free survival (PFS) efficacy of the sac-TMT combo compares favorably to historical data for Keytruda plus chemo."I go to bed and wake up with in my mind there are two things, China and AI," Pfizer CEO Albert Bourla said.Opening that same lung cancer session on May 29, Dizal Pharma showed that its small molecule tyrosine kinase inhibitor Zegfrovy improved PFS by 45% compared with chemo among first-line NSCLC patients with EGFR exon 20 insertion mutations, the exact field where Takeda had stumbled with Exkivity. Compared to Johnson & Johnson’s antibody Rybrevant, used alongside chemo, Zegfrovy offers “the advantage of a single oral agent administration,” John Heymach, M.D., chair of thoracic/head and neck medical oncology at MD Anderson, noted during his presentation.The third Chinese asset sharing the same stage, a next-generation RET inhibitor called lunbotinib, also hails from Kelun.“Over the last three years, especially in emerging fields like bispecifics and ADCs, China has become so essential, some are even saying that if a session doesn’t include presentations or data from China, it’s simply not worth attending,” Dajun Yang, M.D., Ph.D., CEO of Ascentage Pharma, said in an interview with Fierce. “In sectors like bispecifics, bispecific ADCs or protein degraders, up to a third of the studies presented are coming out of China.” The speed engineNew compounds are entering clinical trials in China at an unprecedented speed. In 2015, Ascentage secured five Investigational New Drug (IND) clearances from Chinese regulators across two molecules. At the time, that total IND number ranked third among Chinese biopharmas. Today, China sometimes clears 20 IND approvals in a single week, Yang noted.The sheer volume has caught attention across the Pacific. During a speech to FDA staffers on April 1, then-FDA head Marty Makary, M.D., flagged that China today has four times more phase 1 initiations than the U.S.Paradoxically, China’s IND review timeline is not as fast as the U.S. FDA, Yang observed. Instead, the pace of preclinical lab tests helps set China apart in the speed of the entire IND process. For its BTK degrader candidate APG-3288, Ascentage entered good laboratory practice (GLP) toxicology studies in April 2025 and received FDA IND clearance two days before Christmas—an eight-month process from an IND bid to a regulatory green light.If the GLP work had been done in the U.S., simply waiting in line to launch primate studies could have taken half a year on its own, Yang noted. At ASCO, Ascentage shared phase 1b updates of its olverembatinib, a China-approved third-generation BCR-ABL1 inhibitor and potential competitor to Novartis’ blockbuster Scemblix, in patients with lymphoid blast phase chronic myeloid leukemia (CML) or Ph+ B-cell precursor acute lymphoblastic leukemia, as well as in second-line chronic-phase CML.The drug is commercially partnered with Innovent Biologics in China, while Takeda holds an option to in-license the TKI through a potential $1.3 billion deal signed in 2024. Takeda’s ties with China have been deepening. More recently, the Japanese pharma paid none other than Innovent $1.2 billion upfront for rights to two oncology candidates. One of the programs, a potential first-in-class PD-1/IL-2 bispecific fusion protein called IBI363 (TAK-928), showcased phase 1 proof-of-concept lung cancer data at ASCO 2026. “We actually found that China biotechs currently are just a tremendous source, honestly, of innovation,” Takeda’s oncology R&D head, P.K. Morrow, M.D., told Fierce. “In the past, one might have looked at it as follow-on molecules, and that is completely untrue now.” ‘Their second step’With Takeda, Innovent will co-develop and co-commercialize IBI363. Until recently, this deal structure was not very common compared with early research collaborations, pure licensing arrangements or asset purchases between Chinese biotechs and large multinational pharmas. Similar collaboration terms can also be found in Bristol Myers Squibb’s $15.2 billion, broad partnership with Hengrui Pharma.On the eve of ASCO 2026, Innovent stole the limelight with its own massive multi-asset partnership with Pfizer, which also includes co-development and co-commercialization terms around four assets.“These are clear votes of confidence on the abilities of at least these specific companies—Hengrui and Innovent—to conduct development and generate assets at a similar level to that of their partner multinational pharmas,” Helen Chen, global sector co-head for healthcare and a Greater China managing partner of L.E.K. Consulting, told Fierce.Pfizer examined Innovent’s drug development track record and their discovery engine and was “very excited in what we saw about the quality,” Johanna Bendell, M.D., Pfizer’s chief development officer of oncology, said in an interview.Bendell’s boss is perhaps blunter. “I go to bed and wake up with in my mind there are two things: China and AI,” Pfizer CEO Albert Bourla said in a podcast aired May 20, before quickly adding, “and politics, unfortunately.”Despite the vote of confidence, Innovent CEO Michael Yu, Ph.D., acknowledges that Innovent’s internal capabilities are not yet strong enough to support a solo act on the global market. “That’s why we have to find a company that is willing to take this journey together with us,” Yu told Fierce.The four assets to be co-developed under the Pfizer pact also drew interest from other companies, enabling Innovent to press for the co-development terms, Yu said. For IBI363, Innovent even left higher bids on the table to choose Takeda because the partner, besides global oncology know-how, is willing to work under a co-development framework, he said.For his part, Bourla has already sensed that in deal talks with Chinese companies, Western players no longer hold an overwhelmingly dominant position. “They are focusing on early right now, because they can’t have global clinical development teams yet, and they don’t have commercial development teams yet,” he said during the podcast with Norges Bank Investment Management CEO Nicolai Tangen. “So I’m sure that on the early stage, they would be very quickly better and more productive than us within two years. Then it comes to, they need to transition to being able to take those molecules and bring them to the world alone rather than together with us. And I think that will be their second step.” A China data question? BMS had been a believer in Chinese innovation even before teaming up with Hengrui. At ASCO, the New Jersey pharma’s chief medical officer, Cristian Massacesi, M.D., touted the broad potential of a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), which the pharma giant bought from China’s Sichuan Biokin Pharmaceutical for $800 million upfront. In two phase 3 trials run by Biokin in China, the novel ADC bested chemo on both PFS and OS in patients with previously treated triple-negative breast cancer and esophageal cancer, separately. BMS has now started to conduct registrational studies of the asset globally.But amid the rounds of applause at ASCO and the stream of multibillion-dollar transactions, doubts and uncertainties linger. Despite a positive OS readout from Harmoni-6 that exceeded expectations, Akeso’s stock price first shot up, then dropped Monday as its findings’ translatability from China to a global population came into question.“It’s not necessarily a China question versus a non-China question,” Merck’s Green said. “It has to do with, when you do studies in more homogeneous settings or in smaller groups. There's similar questions to me about, how do things translate when you take it into a broader global study where you’ve got more heterogeneity of care?”Özlem Türeci, M.D., co-founder and chief medical officer of BioNTech, doesn’t think data reproducibility is a China question, either.“China's data is as good as data from any region. It’s also being adopted,” she said in an interview with Fierce. “The point is, if you want to have a global development program with global approvals and global launches, you have to conduct global studies. And that’s the reason why at some point regional studies or regional programs have to move into global and have to show that they can be globally confirmed.”BioNTech has its own rival to ivonescimab, the PD-L1xVEGF bispecific pumitamig, which it initially in-licensed, then fully acquired after buying out China’s Biotheus. BMS quickly signed on to the drug with a co-development and co-commercialization deal. At ASCO, the drug offered the first look at a global data set within the PD-(L)1xVEGF class in first-line NSCLC. Meanwhile, another Chinese asset could give BioNTech—which quickly ascended to global fame as a COVID vaccine maker—its first commercial oncology product. Licensed from China’s Duality Biologics, the HER2 ADC trastuzumab pamirtecan is moving toward an FDA filing after a positive readout in previously treated endometrial cancer. BioNTech got trastuzumab pamirtecan and another ADC from Duality for $170 million upfront in 2023, a time when Chinese biotechs were reeling from a pandemic crunch. Today, as asset quality rises, Chinese drug candidates may be harder to pocket for buyers despite their abundance. In the words of Evaluate analyst Mark Lansdell, China is “not a bargain basement anymore.” While the number of total cross-border licensing deals of Chinese biotech products increased by 120% from 2022 to 2025, the total upfront value jumped about 400%, from $1.1 billion in 2022 to $5.6 billion last year, according to Evaluate. The geopolitical shadowAbove the scientific discussions and deal talks, the dark cloud of geopolitics hovered over the Chicago convention center. Going forward, accessing China's biotech assets could become more difficult for U.S. companies as calls for restricting cross-border deals through the COINS Act grow louder. To some, the solution to maintaining the U.S.’ leadership in biotech is blocking China, along with any collaborations with the country. But others, like Pfizer’s Bourla, have pushed back on this mentality.“[The U.S.] should stop trying with all the heart and brains that they have to put 80% of their effort [on] how to slow down China,” Bourla said during the podcast. “Very big mistake. Because it’s a waste of resources and brain power because you will never slow them down. The genie is out of the bottle. We should put 80% of our focus and effort [on] how to become better than China.”From the U.S. biotech industry’s side, Bruce Booth, partner at Atlas Venture, echoed the sentiment in a June 2 blog post, framing China’s rise as “more opportunity than threat” and “a healthy forcing function to raise the game for everyone.” Still, beneath the big headlines, the friction was felt on the ground at ASCO.“China biotech presence in ASCO [this year] is not as many as the peak years in my memory,” observed Leon Tang, Ph.D., founder of the business development consultancy InScienceWeTrust BioAdvisory, pointing to rising travel costs and visa uncertainty as common concerns.Yet, the pioneers of the space remain undeterred. As more Chinese drugs vie to stage their own Carvykti moment, Frank Fan, M.D., Ph.D., the scientific mind behind the cell therapy’s breakthrough, returned to ASCO this year with a new proposal: an off-the-shelf CAR-T platform with potential for unprecedented production scalability without the need for gene editing. His new company, Wondercel Therapeutics, debuted early data from four patients with diffuse large B-cell lymphoma, showing early signs that its candidate can avoid premature clearance by the host immune system while achieving CAR-T expansion at levels similar to that of autologous CAR-T inside a patient’s body.For his new platform, Fan again hopes to deploy the same partnership model that built Legend—even if a COINS Act expansion would mean a deal with a U.S. company like Carvykti’s partner J&J would not be possible.“Even if obstacles do arise in the future, we still have Europe, Japan and other regions to partner with,” Fan said. “As long as we maintain innovation, and as long as international intellectual property laws remain intact, we remain confident.”Editor's note: Zoey Becker and Darren Incorvaia contributed reporting.

02 Jun 2026

·www.biospace.com

Lantern Pharma Reports HARMONIC™ Data Showing LP-300 Progression-Free Survival Benefit Deepens with Treatment Duration in EGFR Exon 21 L858R Lung Cancer

Exon 21 L858R NSCLC Mutated Patients Treated Through Up to Six Cycles Reached 8.9-Month Median PFS; Durable Responses Beyond Two Years; and a Consistently Clean Safety Profile. PFS benefit deepens with treatment duration : L858R patients treated through up to six cycles of LP-300 reached an 8.9-month median PFS, versus 8.4 months overall (n=15) – future patients will be eligible to receive up to 8 doses of LP-300. Durable, deep responses : tumor reduction in over 70% of evaluable L858R patients, responses beyond two years, and a 77% clinical benefit rate. Clean, treatment-enabling safety : no clinically meaningful toxicity beyond chemotherapy, comparing favorably with amivantamab plus chemotherapy on a cross-trial basis. Partnering and KOL discussions ongoing during ASCO 2026 : updated data and slides filed today on Form 8-K and are in use for partnering and clinical discussions during ASCO 2026 in Chicago. DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, today reported clinical data and updates in the form of a presentation from its ongoing Phase 2 HARMONIC™ trial (NCT05456256) evaluating LP-300 in combination with carboplatin and pemetrexed in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer (NSCLC) who have progressed following TKI-based therapy. The emerging dataset (data cutoff May 11, 2026) reveals a coherent pattern: the progression-free survival benefit of LP-300 deepens with treatment duration, and the signal is most pronounced in the L858R subgroup — a molecularly defined population with a poor prognosis and limited options following frontline TKI therapy. The Company has furnished the presentation and slides as an exhibit to a Current Report on Form 8-K filed today , and is using the updated data and slides for partnering and clinical discussions during ASCO 2026 in Chicago. “What we are seeing is an early signal that strengthens the longer the biomarker specific patients remain on therapy, and very importantly no notable changes in the exceptionally clean safety and tolerability pro LP-300,” said Panna Sharma, CEO & President of Lantern Pharma. “These patient observations and clinical benefit patterns provide the rationale behind the recently FDA-cleared protocol amendment extending LP-300 dosing from a maximum of six to eight cycles, and reinforces the Company’s focus on the highly undermet need for the L858R patient subgroup – which is about 40% of EGFR mutated patients globally.” A Deepening Signal: Benefit Concentrates with Treatment Duration A key finding and early observation emerging from HARMONIC™ is the relationship between treatment duration and depth of benefit. Patients who received up to six cycles of LP-300 derived greater progression-free survival benefit than those treated for fewer cycles, and within the L858R subgroup this duration effect was most evident — a median PFS of 8.9 months in patients treated through up to six cycles, against 8.4 months in the overall L858R cohort (n=15). The L858R subgroup also corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89) favoring L858R. The directional trend toward longer PFS with additional cycles provides the basis for extending treatment duration to eight cycles. Depth and Durability of Response Beyond the duration relationship, the data point to durable disease control in the L858R population. More than 70% of evaluable L858R patients experienced a reduction in target-lesion size — including a complete response and multiple partial responses among the deepest responders — and durable responses were sustained beyond two years in select patients. The L858R cohort showed a 77% clinical benefit rate, consistent with the depth and durability observed across the response data. 8.9 mo Median PFS — L858R, up to 6 cycles >70% Evaluable L858R patients with tumor reduction 2+ yrs Durable responses in select L858R patients 77% Clinical benefit rate — L858R cohort In a multivariable Cox proportional-hazards analysis, L858R remained significantly and independently associated with PFS benefit after adjustment for race and gender (hazard ratio 0.36; 95% CI 0.15–0.90; p=0.028), with the association persisting when adjusting for TP53 mutation status. These analyses are exploratory and based on a small cohort; they are intended to characterize the emerging signal and inform the enriched study design – which Lantern is pursuing going forward – rather than to establish efficacy. A Consistently Clean Safety Pro Extended Treatment Critically, the deepening efficacy signal is accompanied by a tolerability pro supports longer treatment durations. Across patients treated with LP-300 plus chemotherapy (N=31), LP-300 added no clinically meaningful toxicity beyond the carboplatin/pemetrexed backbone. On a cross-trial basis — provided for context only and not a head-to-head comparison — LP-300 plus chemotherapy compared favorably with the FDA-approved amivantamab-plus-chemotherapy regimen reported in the Phase 3 MARIPOSA-2 study (Passaro A, et al. Ann Oncol 2024), particularly on the administration-burden and dermatologic toxicities that most limit sustained treatment in heavily pre-treated patients: Adverse Event (any grade unless noted) LP-300 + Chemo (N=31) Amivantamab + Chemo (N=130)¹ Treatment-related serious adverse event 3% 23% TEAE leading to dose delay (any study drug) 19% 65% TEAE leading to drug discontinuation 6% 18% Infusion-related reaction (TRAE) 7% 58% Rash (TRAE) 7% 43% Paronychia (TRAE) 0% 36% Stomatitis (TRAE) 0% 31% ¹ Cross-trial comparison; not a head-to-head study. Amivantamab + chemotherapy data from Passaro A, et al. Annals of Oncology 2024;35(1):77–90 (MARIPOSA-2). LP-300 + chemotherapy data are preliminary; HARMONIC™ data cutoff May 11, 2026. Competitive Context: Comparable Efficacy, Differentiated Tolerability Amivantamab plus chemotherapy is FDA-approved in the post-osimertinib setting and represents the current benchmark in this space, with a reported 9.7-month median PFS in L858R patients. LP-300’s emerging pro positioned not as a claim of superior anti-tumor efficacy, but as a comparable efficacy range with a substantially more favorable safety, tolerability, and administration profile — highly relevant in a heavily pre-treated population where tolerability drives real-world outcomes such as quality of life, reduced costs and reduced clinical burden. Regimen ORR mPFS Key Tolerability Profile LP-300 + Carboplatin + Pemetrexed (HARMONIC™ — L858R enriched) 43%* 8.4 mo* (6.2–NE) 8.9 mo** Grade 1–2 predominant; no new added toxicity vs. chemo; 3% serious TRAEs Amivantamab + Chemo (MARIPOSA-2) [FDA-approved, post-osimertinib] (L858R patients) 36% 9.7 mo (5.9–11.3) 23% serious TRAEs; 58% infusion reactions; 36% paronychia Carboplatin + Pemetrexed alone (historical standard of care) 27–36% 4.2–5.5 mo Standard chemotherapy toxicities *Preliminary data. ORR derived from the initial safety lead-in (n=7); HARMONIC™ mPFS from the L858R-enriched cohort (n=31, data cutoff May 11, 2026). **Patients who received up to six cycles. All comparisons are cross-trial and not head-to-head. NE = not estimable. Featured for Partnering and Clinical Discussions During ASCO 2026 The convergence of a duration-dependent efficacy signal with a clean, sustainable safety pro a clear strategic implication: patients can be treated longer, and longer treatment appears to deepen benefit. This relationship underpins the recently FDA-cleared amendment extending LP-300 dosing to eight cycles and the Company’s decision to concentrate enrollment on the L858R subgroup. Lantern Pharma has furnished the accompanying slides on Form 8-K and is using the updated dataset for partnering and clinical discussions during ASCO 2026 in Chicago, including potential global and regional licensing and co-development opportunities in never-smoker NSCLC. The Company expects to report additional data as the enriched L858R cohort matures. LP-300 Shaped & Supported By Lantern’s AI Platform For Drug Development Indication development and refinement for LP-300 were in part supported by early observations from prior trials and large scale differential gene expression and mutational analysis across NSCLC data sets. Panna Sharma commented, "Our LP-300 program reflects a data-driven, AI-powered approach to understanding how a previously overlooked molecule could meaningfully serve the needs of L858R NSCLC patients — a population that has consistently underperformed on existing therapies. The convergence of molecular modeling, high-resolution biology, and biomarker-driven patient selection is fundamentally changing what is possible for precision oncology drug developers, and we believe LP-300 is well positioned at that intersection." About the HARMONIC™ Trial HARMONIC™ (NCT05456256) is a Phase 2 clinical trial investigating LP-300 in combination with pemetrexed and carboplatin in never/non-smoker patients with advanced lung adenocarcinoma that has progressed following prior TKI therapy. The trial has enrolled in the United States, Taiwan, and Japan. Primary endpoints are progression-free survival and overall survival; secondary endpoints include objective response rate, duration of response, and clinical benefit rate. About LP-300 LP-300 is a small-molecule investigational agent with a multimodal mechanism of action, including receptor tyrosine kinase modulation and redox regulation. It has been administered to more than 1,000 individuals across prior clinical studies. LP-300 is being developed using insights from Lantern’s proprietary RADR® AI platform. LP-300 has not received marketing approval from the FDA or any other regulatory authority for any indication. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. Its proprietary RADR® platform leverages machine learning and large-scale genomic and clinical data to identify biomarker signatures and guide the development of targeted therapies for patients with significant unmet need. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; plans, objectives and expectations regarding the HARMONIC™ clinical trial; LP-300’s potential clinical activity and tolerability profile; our clinical development plans; expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others.. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and emerging or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that any clinical benefit observed to date relating to LP-300 may not be reproduced in the completed HARMONIC™ trial or in larger or confirmatory studies, (iv) the risk that clinical data referenced in this press release relating to the HARMONIC™ clinical trial are exploratory and preliminary, based on small patient cohorts, and may not be representative of outcomes in broader populations, (v) the risk that cross-trial comparisons are provided for context only and should not be interpreted as direct evidence of comparative safety or efficacy, (vi) the risk that our research and the research of our collaborators may not be successful, (vii) the risk that we may not be successful in licensing our product candidates or in completing potential partnerships and collaborations, (viii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (ix) the risk that no drug product based on our proprietary AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, and (x) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at or on the SEC's website at . Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Contacts Investor & Media Contact Investor & Media Relations Email: IR@lanternpharma.com Phone: (972) 277-1136

Clinical ResultPhase 2Phase 3

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	Janssen-Cilag International NV	26 Jan 2024
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
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


NCT05379595 (OrigAMI‑1, ASCO2026)	Phase 1/2	RAS/BRAF Wild Type Colorectal Cancer RAS/BRAF wild-type	73	Amivantamab (CMS2)	iwibttsdbh(sfuoxkzijv) = tnblporzrt lhpmozvxhq (kncbgawzch ) View more	Positive	29 May 2026
				Amivantamab (CMS4)	iwibttsdbh(sfuoxkzijv) = tzeznbopbq lhpmozvxhq (kncbgawzch ) View more
WJOG17323L (ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutations	70	Amivantamab + lazertinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	fcopeqqswz(fuxinbwusx) = wsgemusynq uwbtojuewk (cxrunizogm ) View more	Positive	29 May 2026
				Afatinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	fcopeqqswz(fuxinbwusx) = bwvtzffwsh uwbtojuewk (cxrunizogm ) View more
NCT06667076 (COPERNICUS, ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutated	190	SC amivantamab + lazertinib	ypgafbkcld(jexrypeutw) = gecfjrrkrz prgzjkjiik (rersffvtot ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer Second line EGFR-mutant	4,909	Platinum-pemetrexed chemotherapy (Chemo)	rngxuqogdh(uscwcansrp): HR = 1.92 View more	Positive	29 May 2026
				immunotherapy +Chemo (IC)
ASCO2026	Not Applicable	-	15	oral doxycyclinetopical clindamycinl corticosteroids + oral doxycyclinetopical clindamycin + oral doxycyclinetopical clindamycin	iknuzjreur(dknwszqjib) = vigxtakjes aqunyixloz (lzregvujns ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	EGFR positive non-small cell lung cancer Second line	22	Amivantamab monotherapy	xhsnotdvdh(qmaxclogrh) = oaunohfkee ltfffejcpg (cyiajyuziv, 36.1 - 80.9) View more	Positive	29 May 2026
				Amivantamab monotherapy (classical EGFR)	xhsnotdvdh(qmaxclogrh) = tyauaxjgma ltfffejcpg (cyiajyuziv ) View more
NCT04077463 (CHRYSALIS-2, ASCO2026)	Phase 1	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutations	49	Amivantamab plus lazertinib	zzkneozlih(gxdevtcmdk) = vbjkfsfzis rvuuflnqmv (ffaggngxgz, 27.7 - NE) View more	Positive	29 May 2026
NCT06385080 (OrigAMI-4, ASCO2026)	Phase 1/2	Recurrent Squamous Cell Carcinoma of the Head and Neck	102	Amivantamab	smspezhkcz(ikbhwjknik) = zcnlfghbyq mthbabucxg (npfnriuzcs, 37 - 57) View more	Positive	29 May 2026
NCT05074940 (Phase 2 clinical trial, CTgov)	Phase 2	Adenoid Cystic Carcinoma \| Salivary Gland Neoplasms	21	Amivantamab	kavwtippbo = xlyeybzsef uxnzbdehea (urcdahpzmt, awouvpjklv - sioxalldrf) View more	-	08 May 2026
NCT06662786 (OrigAMI-2, AACR2026)	Phase 3	RAS/BRAF Wild Type Colorectal Cancer First line RAS/BRAF WT	1,000	Amivantamab + FOLFOX/FOLFIRI	gnxrohnxrw(fwaqpabqpm) = qchfynfzue fqoehwnqrq (qftxuodacw )	Positive	21 Apr 2026
				Cetuximab + FOLFOX/FOLFIRI	erkfhmvoxg(asrujpzmvb) = ajbfkblzvp kprphropbh (ukgsznzmla ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis