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

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

Efficacy and safety of distinct regimens for individuals with advanced EGFR-mutated non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitors: A systematic review and network meta-analysis. (ASCO 2025) - " 14 RCTs, involving 3177 participants and 8 treatment regimens (chemotherapy plus ivonescimab (PD-1/VEGF inhibitor) [CT+IVO]; CT+amivantamab+lazertinib [CT+AMI+LAZ], CT+immunotherapy+bevacizumab [CT+IO+BEV], CT+AMI, CT+BEV, CT+IO, CT, and IO), were included. Integrating the results of different clinical outcomes and subgroup analyses, we conclude that CT+IVO is the optimal treatment option with an acceptable safety profile for patients with advanced EGFR-mutated NSCLC who have progressed on TKIs. CT+AMI+LAZ and CT+AMI are alternative subsequent line options as well, with superior efficacy compared to immunotherapy-based or chemotherapy regimens, yet elevated toxicity profiles requiring vigilant management."

IO biomarker • Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Optimizing management of stage IV EGFR mutant non-small cell lung cancer in Asia: An expert opinion. (PubMed, Int J Cancer) - "The panel recommended careful selection of patients for osimertinib+chemotherapy or lazertinib+amivantamab based on safety and efficacy profile, patient age, and disease status. For lazertinib+amivantamab, measures to mitigate adverse events such as the use of pre-medication with steroids, prophylactic anticoagulants, and dose modification are recommended. For patients progressing on one of the combination regimens, experts recommended repeat NGS testing and continued treatment with chemotherapy."

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

Risk of pulmonary toxicities in patients with EGFR-mutant non-small cell lung cancer (NSCLC) treated with amivantamab: A systematic review and meta-analysis of phase 3 randomized controlled trials. (ASCO 2025) - "MARIPOSA tested amivantamab-lazertinib vs osimertinib vs lazertinib, while MARIPOSA-2 involved amivantamab-lazertinib-chemotherapy vs chemotherapy vs amivantamab-chemotherapy, and PAPILLON tested amivantamab-chemotherapy vs chemotherapy. This study revealed a higher risk of ILD and pneumonitis in patients with EGFR-mutant NSCLC treated with amivantamab combination regimens compared to chemotherapy alone. However, amivantamab has shown a similar safety profile to the standard treatment in terms of respiratory infections incidence. Prompt identification and providing the proper management and supportive care are crucial in managing those pulmonary toxicities, and ultimately, optimizing the patients' quality of life."

P3 data • Retrospective data • Review • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Effectiveness and safety of the amivantamab to lazertinib versus lazertinib alone in EGFR mutant metastatic non-small-cell lung cancer: Systematic review and meta-analysis. (ASCO 2025) - "The combination of amivantamab and lazertinib provides greater efficacy than monotherapy with lazertinib for EGFR mutant metastatic NSCLC, and the safety profile is acceptable. These findings support the integration of combination therapy into clinical practice, although further large-scale randomized trials are warranted."

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

Genomic predictive biomarkers of anti-EGFR resistance in EGFR-mutated non-small-cell lung cancer: Impact of classical mutations, comutations and secondary CNVs. (ASCO 2025) - "Our findings highlight the importance of secondary CNVs in NSCLC EGFR-mutated L858R. Tumors with Ex19del show a better prognosis in likely relation to a lower presence of CNVs, being tumors with less clonal heterogeneity. These results are essential in the selection of pts for the different standard therapies (Osimertinib, Osimertinib-chemotherapy or Amivantamab-Lazertinib) and the future clinical trials."

Biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDKN2A • EGFR • FGFR1 • KRAS • TP53

Thrombotic events and mortality associated with bispecific antibodies in lung cancer: A systematic review. (ASCO 2025) - "Amivantamab (EGFR + MET) and tarlatamab (Delta-like ligand 3 x CD3) were used in 80% and 20% of cases for advanced non–small cell lung cancer (NSCLC) and extensive stage small-cell lung cancer, respectively. Additional therapies included lazertinib (60%), carboplatin/pemetrexed (20%), and no therapy in (20%) cases... Thrombotic events and all-cause mortality are significant concerns in patients receiving bispecific antibodies in lung cancer. While these findings highlight the need for vigilance, further studies with larger cohorts and long-term follow-up are essential to better understand the safety profile."

Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Embolism • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • EGFR

Incidence of venous thromboembolism (VTE) events in patients with EGFR-mutant non-small cell lung cancer (NSCLC) treated with amivantamab: A systematic review and combined meta-analysis of phase 3 randomized controlled trials. (ASCO 2025) - "MARIPOSA tested amivantamab-lazertinib vs osimertinib vs lazertinib, while MARIPOSA-2 involved amivantamab-lazertinib-chemotherapy vs chemotherapy vs amivantamab-chemotherapy, and PAPILLON tested amivantamab-chemotherapy vs chemotherapy. This study showed increased risk of VTE events in patients with EGFR-mutant NSCLC treated with amivantamab-containing regimens compared to the standard arm. These findings highlight the importance of close monitoring for those events in order to early detect and provide the appropriate management. Further studies are needed to better understand this association between amivantamab and VTE."

P3 data • Retrospective data • Review • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Venous Thromboembolism • EGFR

Dermatologic prophylaxis and impact on patient-reported outcomes in first-line EGFR-mutant advanced NSCLC treated with amivantamab plus lazertinib: Results from the phase 2 COCOON trial. (ASCO 2025) - P2 | "COCOON DM included oral doxycycline/minocycline (100 mg BID Wks 1–12), clindamycin 1% lotion on scalp (QD Wks 13–52), chlorhexidine 4% to wash hands and feet QD, and non-comedogenic ceramide-based moisturizer to body and face QD. Among pts with EGFR-mutant advanced NSCLC, COCOON DM reduced the severity of dermatologic AEs and reduced the impact of those AEs on QoL compared to SoC DM."

Clinical • Metastases • P2 data • Patient reported outcomes • Dermatopathology • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Phase 2 cohort-2 trial in progress: Vabametkib plus lazertinib for patients with EGFR-mutant NSCLC who developed resistance to 1st-line, 3rd-gen-EGFR TKIs via C-Met dysregulation. (ASCO 2025) - P2 | "Recently, lazertinib, combined with amivantamab, has been approved as a potential first-line therapy for NSCLC. Key secondary endpoints include objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and duration of response (DOR). Additionally, safety and patient-reported outcome will be evaluated."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Neoadjuvant lazertinib with or without chemotherapy for patients with epidermal growth factor receptor (EGFR)-mutated resectable non-small cell lung cancer (NSCLC): NeoLazer trial. (ASCO 2025) - P2, P3 | "In resectable EGFR-mutated NSCLC, adjuvant osimertinib has been shown to significantly improve disease-free survival and overall survival...The trial will enroll approximately 160 patients, who will be randomized 1:1 to receive either lazertinib (240 mg once daily) with chemotherapy (pemetrexed 500 mg/m² and carboplatin AUC5 every 3 weeks) or lazertinib alone (240 mg once daily) for three cycles before surgical resection...Secondary endpoints include safety based on CTCAE 5.0, type of surgical resection (segmentectomy vs. lobectomy), pathologic complete response, objective response rate based on RECIST 1.1, event-free survival, disease-free survival, and overall survival. In addition, the trial incorporates exploratory analyses, including whole-genome sequencing of tumor tissue and monitoring the dynamics of minimal residual disease through serial blood sampling."

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

A trispecific antibody targeting EGFR/cMET/VEGF-A demonstrates multiple mechanisms of action to inhibit wild-type and mutant NSCLC animal models. (PubMed, Front Oncol) - "TAVO412 demonstrated more potent antitumor activity than amivantamab and cetuximab in NSCLC xenograft models using cell lines with varying levels of mutant and wild-type EGFR and cMET. Moreover, TAVO412 in combination with osimertinib, lazertinib, docetaxel, and radiotherapy, resulted in complete and durable regression of NSCLC xenograft tumors. These findings highlight TAVO412 as a promising therapeutic agent with multiple mechanisms of action and strong potential for synergistic combinations in NSCLC treatment."

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

Blood-based biomarkers for predicting treatment response to immune checkpoint inhibitors after EGFR-TKI resistance (AACR 2025) - "First-line EGFR-TKIs included erlotinib (n=15), afatinib (n=9), and gefitinib (n=4). T790M mutations were identified in 11 patients, of whom 10 received osimertinib and 1 received lazertinib. ICIs included atezolizumab (n=15), pembrolizumab (n=5), and nivolumab (n=8)... Plasma samples collected after EGFR-TKI resistance can predict ICI responses in EGFR-mutant NSCLC. Post-resistance plasma biomarker levels may serve as a minimally invasive approach to guide therapeutic decisions in this challenging patient population."

Biomarker • Checkpoint inhibition • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • GZMH • IL4 • IL6 • PD-L1

Orally effective FDA-approved protein kinase targeted covalent inhibitors (TCIs): A 2025 update. (PubMed, Pharmacol Res) - "The clinical efficacy of ibrutinib, a Bruton tyrosine kinase blocker, in the treatment of mantle cell lymphoma following its 2013 approval helped to overcome a general bias against the development of irreversible drug inhibitors. Other approved targeted covalent inhibitors include acalabrutinib and zanubrutinib, which also block Bruton tyrosine kinase. Afatinib, dacomitinib, lazertinib, mobocertinib, and osimertinib inhibit members of the epidermal growth factor receptor family (ErbB1/2/3/4) and are used in the treatment of non-small cell lung cancers. Neratinib inhibits ErbB2 and is used in the management of ErbB2/HER2-positive breast cancer. Futibatinib blocks the fibroblast growth factor receptor family and is prescribed for the treatment of cholangiocarcinoma while ritlecitinib, which inhibits JAK3, is used in the management of alopecia areata. The eleven drugs considered in this review have a common mechanism of action involving the addition of a protein cysteine..."

FDA event • Journal • Review • Alopecia • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BTK • EGFR • FGFR

CHRYSALIS: Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=751 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jan 2024 ➔ Dec 2025

Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • MET

Navigating First-Line Treatment Options for Patients With Epidermal Growth Factor Receptor-Positive Non-Small Cell Lung Cancer. (PubMed, Am Soc Clin Oncol Educ Book) - "First-line regimens for patients with EGFR-positive NSCLC now include EGFR tyrosine kinase inhibitor monotherapy or combination therapy with osimertinib and chemotherapy or amivantamab and lazertinib. Importantly, there are subpopulations of patients who may benefit more from combination therapy, including those with TP53 comutations, high tumor burden, brain metastases, and/or detectable ctDNA. This review discusses current data and treatment approaches for the management of advanced/metastatic EGFR-mutant NSCLC, with a particular emphasis on the complexity of first-line management."

Journal • Review • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=390 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Oct 2025 ➔ Aug 2027

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

Yuhan Receives 20.7 Bil. Won Milestone Payment for LECLAZA Launch in Japan (Business Korea) - "Yuhan Corp. is set to receive a milestone payment of 20.7 billion won following the launch of its non-small cell lung cancer treatment LECLAZA in Japan. The company announced on May 30 that it will receive a milestone payment of $15 million (approximately 20.7 billion won) for achieving staged milestones of lazertinib (LECLAZA), which was licensed out to Janssen Biotech. This amount represents about 1% of Yuhan Corp.’s consolidated sales for the previous year....According to the contract, Yuhan Corp. will receive the milestone payment within 60 days. The company is also expected to receive royalties from future sales of LECLAZA....LECLAZA is expected to receive marketing authorization in China within this year. In this case, Yuhan Corp. will secure a milestone payment of $45 million. In Europe, the launch is anticipated in the third quarter. The company is set to receive a milestone payment of $30 million for the European launch."

China approval • Financing • Launch Europe • Non Small Cell Lung Cancer

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Abion Inc | N=40 ➔ 178 | Trial completion date: Aug 2025 ➔ Feb 2029 | Trial primary completion date: Apr 2025 ➔ Feb 2029

Enrollment change • Trial completion date • Trial primary completion date • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • MET

Cost Comparison of Osimertinib Plus Chemotherapy Versus Amivantamab Plus Lazertinib for the First-Line Treatment of Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC (ISPOR 2025) - "From a US payer perspective,osimertinib plus chemotherapy is associated with significantly lower overallcosts compared to amivantamab plus lazertinib for the treatment of patientswith EGFRm locally advanced or metastatic NSCLC."

Clinical • HEOR • Metastases • Reimbursement • US reimbursement • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Analytical Approaches to Estimate Medication Persistence From Electronic Health Record Data: A Study of Tyrosine Kinase Inhibitors in Patients With Epidermal Growth Factor Receptor-Positive Advanced Non-Small Cell Lung Cancer (ISPOR 2025) - "This study compared approaches for estimating the persistence of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI), including erlotinib, gefitinib, dacomitinib, afatinib, osimertinib, and lazertinib, among patients with EGFR-positive advanced non-small cell lung cancer (advNSCLC). The non-TTE approach estimated higher EGFR TKI persistence than the TTE approach at all timepoints. The TTE approach accounts for censoring and estimates cumulative persistence, whereas the non-TTE approach provides a point-in-time snapshot. The TTE approach may also provide insights into other real-world outcomes, such as real-world treatment duration."

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

Cost-effectiveness analyses of amivantamab plus lazertinib and lazertinib versus osimertinib in non-small cell lung cancer with EGFR mutations. (PubMed, Front Pharmacol) - P3 | "The substantial drug acquisition costs are the primary contributors to the unfavorable economic profiles of these treatments. Hence, future clinical implementations should carefully weigh the considerable therapeutic benefits against the significant financial burdens to achieve an optimal risk-benefit equilibrium."

HEOR • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Amivantamab with lazertinib - stage IV non-small cell lung cancer with EGFR exon 19 deletion or L858R mutation (PubMed, Bull Cancer) - No abstract available

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

Lazertinib: a novel EGFR-TKI therapy for non-small cell lung cancer. (PubMed, Expert Opin Drug Metab Toxicol) - "Preclinical studies demonstrated its superior selectivity for mutant EGFR and blood-brain barrier penetration compared to osimertinib. Clinical trials highlight its efficacy as monotherapy and in combination with amivantamab, showing improved progression-free survival and response duration in patients with advanced NSCLC...However, emerging resistance mutations, such as C797S, underscore the need for continued innovation, including combination therapies and fourth-generation TKIs. Future research must address these challenges to optimize treatment outcomes for NSCLC patients."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

J&J launches Yuhan-partnered lung cancer combo in Japan as AstraZeneca secures Tagrisso expansion (Korea Biomedical Review) - "On Wednesday, J&J said it launched the combination of Rybrevant (amivantamab) and Yuhan's Lazcluze (lazertinib, marketed as Leclaza in Korea) for the first-line treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations....Japan’s reimbursement agency has priced the tablets at 4,403.30 yen ($30.75) for the 80 mg version and 12,354.70 yen ($86.29) for 240 mg....On Monday, the British-Swedish pharma said Japan had approved 40 and 80 mg tablets of Tagrisso (osimertinib) for maintenance use in unresectable, locally advanced EGFR-mutant NSCLC following definitive chemoradiotherapy -- a label expansion backed by phase 3 LAURA data."

Launch Japan • Pricing • Non Small Cell Lung Cancer