Lazcluze (lazertinib) / Yuhan Corp, J&J, Oscotec - LARVOL DELTA

After entering the U.S. and Europe one after another last year, Leclaza was approved for sale in China this time, and Leclaza has all three major pharmaceutical markets in the world. (Maeil Business Newpaper) - "According to the industry on the 31st, China's National Drug Administration (NMPA) officially approved the sale of Leclaza the day before. Earlier, Janssen, which holds the global copyright of Leclaza, applied for permission from the Chinese authorities to use the combination therapy of Leclaza and its antibody treatment 'Rybrevant (component name: amivantamab)' in patients with advanced and recurrent non-small cell lung cancer with positive epithelial cell growth factor receptor (EGFR) mutation...With the approval, Yuhan will receive an additional $45 million (about 62.8 billion won) in milestones...Leclaza and Rybrevant combination therapy in the first half of this year amounted to $320 million (about 440 billion won). Compared to the first half of last year ($116 million), it has nearly tripled. The $252 million, or nearly 80% of total sales, came from the United States."

China approval • Launch non-US • Sales • Non Small Cell Lung Cancer

Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated non-small cell lung cancer: Patient satisfaction and resource utilization results from the PALOMA-3 study. (PubMed, Eur J Cancer) - "In PALOMA-3, subcutaneous amivantamab, which simplifies and shortens administration, reduces resource utilization, and enhances treatment experience, was a preferred option for patients who received amivantamab-lazertinib."

HEOR • Journal • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Venous Thromboembolism • EGFR

Predictive Value of Inflammatory Biomarkers in EGFR-Mutant NSCLC Treated with Lazertinib: An Interim Analysis of a Prospective Real-World Study (OREINT) (ESMO 2025) - No abstract available

Biomarker • Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Cost of adverse event (AE) management in first-line (1L) EGFR-mutated (EGFRm) advanced NSCLC treated with osimertinib + platinum-pemetrexed (osi + CTx) vs amivantamab + lazertinib (ami + laz) (ESMO 2025) - No abstract available

Adverse events • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

COPERNICUS: A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2029 ➔ Nov 2030

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks (Q4W) Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Redefining Tolerability: A Head-To-Head IPD Toxicity Comparison of Amivantamab+Lazertinib vs Osimertinib+Chemotherapy in EGFR-Mutant NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Head-to-Head • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Efficacy of Lazertinib in Treatment-Naive Patients for EGFR Mutated Non-Small Cell Lung Cancer With Brain Metastases (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

First-Line Lazertinib With or Without Local Ablative Radiotherapy in Oligo-Metastatic EGFR-Mutant NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Validation Analysis of MET Ihc as a Biomarker for Amivantamab-Lazertinib Response in Post-Osimertinib Egfr-Mutated NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2025.1 (ASCO.org) - "EGFR Exon 19 Deletion, Exon 21 L858R Substitution...First-Line Treatment Options Update: Recommendation 1.1.1 - Clinicians may offer osimertinib with platinum doublet chemotherapy or amivantamab plus lazertinib (Evidence quality: Moderate; Strength of recommendation: Weak); NRG1 Fusion...Second-Line Treatment Options Update: Recommendation 2.20 - Clinicians may offer zenocutuzumab (Evidence quality: Low; Strength of recommendation: Strong)"

Clinical guideline • Non Small Cell Lung Cancer

Enhanced vs Standard Dermatologic Management With Amivantamab-Lazertinib in EGFRm Advanced NSCLC: The COCOON Global RCT (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Johnson & Johnson Lifts Annual Forecast After Strong Cancer Drugs, Medtech Performance (Benzinga) - "The pharmaceutical giant reported sales of $23.74 billion, up 5.8% year over year and beating the consensus of $22.85 billion. Operational growth was 4.6%, and adjusted operational growth was 3%...Erleada (apalutamide), Rybrevant/Lazcluze in oncology...Cancer sales increased to $6.31 billion, up 24% (+22.3% operational)."

Sales • Hormone Sensitive Prostate Cancer • Non Small Cell Lung Cancer • Prostate Cancer

Comprehensive management strategies for amivantamab-induced toxicities and review of the literature. (PubMed, J Oncol Pharm Pract) - "While third-generation TKIs like osimertinib, lazertinib, and aumolertinib are effective, resistance often arises...Diarrhea is managed with hydration, loperamide, and dose interruption. Infusion-related reactions (IRRs) are treated symptomatically, with epinephrine in severe cases...Pneumonitis is managed by discontinuing amivantamab and using glucocorticoids.ConclusionsAmivantamab is effective for EGFR mutant NSCLC but can cause adverse effects. Understanding these effects and implementing management strategies can optimize outcomes, maintaining treatment efficacy."

Journal • Review • Cardiovascular • Dental Disorders • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pruritus • Solid Tumor • Stomatitis • MET

J&J and Yuhan push challenger to AZ’s Tagrisso in Korea with next-phase Rybrevant combo (Korea Biomedical Review) - "Yuhan Corp. is wrapping up its chemo-free phase 2 lung cancer trial just as Johnson & Johnson pushes for reimbursement of Rybrevant in Korea -- doubling down on a combo that has already shown an overall survival edge over AstraZeneca’s Tagrisso (osimertinib)....The AMAZE-lung study, backed by J&J and run through the European Thoracic Oncology Platform, pairs Yuhan's Leclaza (lazertinib) with Rybrevant (amivantamab) and Pfizer’s Zirabev, a biosimilar to Roche’s Avastin (bevacizumab)...According to an updated entry on ClinicalTrials.gov as of July 1, enrollment is now closed across 18 sites in Europe, and the trial has shifted into follow-up....After notching a regulatory nod in January for the Leclaza-Rybrevant combo, J&J has now filed for reimbursement, a spokesperson for Korea’s Health Insurance Review and Assessment Service (HIRA) confirmed to Korea Biomedical Review....That filing rides on the back of MARIPOSA trial data..."

Enrollment closed • Non Small Cell Lung Cancer

CARDIAC AND VASCULAR TOXICITY OF AMIVANTAMAB IN NON-SMALL CELL LUNG CANCER (NSCLC): A SYSTEMATIC REVIEW. (PubMed, Crit Rev Oncol Hematol) - "Pulmonary embolism and venous thromboembolism are the most common cardiovascular toxicities reported for amivantamab, and their risk increases when combined with lazertinib. These results indicate that amivantamab may be cardiotoxic, especially when combined with lazertininb, and cardioprotection should be considered in patients under amivantamab treatment."

Clinical • Journal • Review • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

Lazertinib Versus Osimertinib in Previously Untreated EGFR-mutant Advanced NSCLC: A Randomized, Double-blind, Exploratory Analysis From MARIPOSA. (PubMed, J Thorac Oncol) - "Lazertinib showed comparable efficacy and safety to osimertinib, including in predefined subgroups."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Mitigation and Management of Adverse Events Associated With Amivantamab Therapy. (PubMed, Oncologist) - "Intravenous amivantamab is approved and recommended by treatment guidelines as a first-line treatment (1L) in combination with lazertinib, as a second-line treatment (2L) in combination with chemotherapy in adults with advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as 2L monotherapy or 1L in combination with chemotherapy in adults with advanced or metastatic NSCLC with exon 20 insertion-mutations. Recommendations are summarized from published guidelines and the authors' clinical experience for the prevention and management of adverse reactions associated with amivantamab. An understanding of the expected adverse events with amivantamab regimens, along with the range of prophylactic and management options available, may facilitate maintenance of ongoing treatment in patients deriving clinical benefit and improve patient quality of life on therapy."

Adverse events • Journal • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor

AMAZE-lung: Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: ETOP IBCSG Partners Foundation | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EFFICACY AND SAFETY OF AMIVANTAMAB PLUS LAZERTINIB VS OSIMERTINIB AND CHEMOTHERAPY IN EGFR-MUTANT NON-SMALL CELL LUNG CANCER: A SYSTEMATIC REVIEW AND META-ANALYSIS (CHEST 2025) - No abstract available

Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Recruiting | Trial completion date: Oct 2025 ➔ Apr 2027

Enrollment open • Trial completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • MET

PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=192 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • MET

Dermatologic Adverse Event Mitigation and Management Strategies with Amivantamab + Lazertinib Therapy for Advanced Non-Small Cell Lung Cancer: A Vodcast. (PubMed, Target Oncol) - "The MARIPOSA study assessed amivantamab + lazertinib versus osimertinib in previously untreated patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. While dermatologic AEs are common, effective proactive management strategies, as demonstrated in the COCOON study, can help reduce the incidence and severity of dermatologic AEs. Prioritizing education for healthcare providers and patients will facilitate timely identification and proactive and reactive management of these events, ultimately improving the treatment experience for patients undergoing therapy with amivantamab and lazertinib."

Adverse events • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Lazertinib as First-Line Treatment for EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). (PubMed, Hematol Oncol Stem Cell Ther) - "Lazertinib demonstrated a greater therapeutic benefit for patients with EGFR-mutated advanced NSCLC compared to first-generation EGFR-TKIs. Further research is needed to validate these findings."

Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Yuhan secures US patent for lung cancer drug lazertinib, blocking copycats (Korea Biomedical Review) - "Korea’s Yuhan Corp. is tightening its grip on U.S. rights to its homegrown EGFR inhibitor lazertinib, branded locally as Leclaza and overseas as Lazcluze, by securing a new formulation patent aimed at keeping generics at bay even after core exclusivity runs out. On June 3, the U.S. Patent and Trademark Office granted Patent No. 12,318,390 B2, covering an oral formulation of lazertinib for EGFR-mutant non-small cell lung cancer, designed to stabilize stomach absorption and reduce swings in drug levels tied to food intake or acidity."

Patent • Non Small Cell Lung Cancer