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

Lazertinib in EGFR-Mutated NSCLC with CNS Metastases: Reinforcing the Role of Third-Generation TKIs through Pooled Analysis. (PubMed, Clin Lung Cancer) - No abstract available

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

Overall survival for amivantamab plus lazertinib vs osimertinib in Asian participants with first-line EGFR-mutant advanced NSCLC: MARIPOSA subgroup analysis (ESMO Asia 2025) - P3 | "Consistent with the overall population, ami+laz meaningfully reduced the risk of death vs osi among Asian pts with 1L EGFRm advanced NSCLC and is projected to provide an OS benefit of >12 mo. These results among Asian pts confirm the findings from the overall MARIPOSA population, establishing ami+laz as a new SoC."

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

Pragmatic trial in progress: Outcomes of enhanced AE prophylaxis in Chinese patients with EGFR-mutated advanced NSCLC receiving amivantamab-based regimens (AmiCARE) (ESMO Asia 2025) - "Cohort 1 (n=40): Ex19del / Ex21 L858R; 1L amivantamab + lazertinib + IRR, skin, and VTE prophylaxis Cohort 2 (n=42): Ex19del / Ex21 L858R; 2L amivantamab + chemo + IRR and skin prophylaxis Cohort 3 (n=40): EGFR Ex20ins; 1L amivantamab + chemo + IRR and skin prophylaxis The primary endpoint is the proportion of patients with improved or stable QoL (measured by EORTC QLQ-C30) at Month 3. Secondary endpoints include QoL at Month 6, incidence and severity of AEs, as well as exploratory efficacy outcomes such as objective response rate (ORR), progression-free survival (PFS), and time to treatment failure (TTF). Data will be collected via routine clinical documentation and patient-reported outcomes over a 12-month follow-up."

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

Lazertinib with or without chemotherapy in MRD positive, previously untreated EGFR-mutant, advanced NSCLC (CHAMELEON study) (ESMO Asia 2025) - P2 | "Assuming an MRD positivity rate of 70%, MRD-positive patients will be randomized to receive either escalated regimen (lazertinib plus platinum-based chemotherapy of pemetrexed 500mg/m2 plus carboplatin AUC5 (arm A, n=43) or continue lazertinib monotherapy (Arm B, n=43) while MRD negative patients will continue to receive lazertinib monotherapy (Arm C, n=37). Trial activation occurred on August 1, 2024. Results from this trial will provide evidence to the ongoing debate on the extent of benefit of chemotherapy to EGFR TKI monotherapy as well as define patient subgroups that will benefit most."

Metastases • Minimal residual disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Prophylactic management of dermatologic adverse events with amivantamab + lazertinib treatment in 1L EGFR-mutated NSCLC: COCOON asian subset analysis (ESMO Asia 2025) - P2 | "Among Asian pts, COCOON DM reduced DAEI incidence & severity by Wk 12. The uncomplicated prophylactic COCOON DM regimen enhances the risk-benefit profile of 1L ami + laz for Asian pts with EGFR-mutated NSCLC."

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

Response to the Letter to the Editor: "Lazertinib in EGFR-Mutated NSCLC with CNS Metastases: Reinforcing the Role of Third-Generation TKIs through Pooled Analysis". (PubMed, Clin Lung Cancer) - No abstract available

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

Amivantamab plus Lazertinib (MARIPOSA) (WLCC 2026) - No abstract available

Lung Cancer

RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) delivers statistically significant and clinically meaningful improvement in overall survival benefit for Asian patients with EGFR-mutated non-small cell lung cancer in the Phase 3 MARIPOSA study (PRNewswire) - "These results were presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Asia Congress 2025....Results from 501 participants who self-identified as Asian in the MARIPOSA trial, showed those treated with amivantamab plus lazertinib had a 26 percent lower risk of death compared with osimertinib....Median OS for the combination was not yet reached compared with 38.4 months for osimertinib (95 percent CI, 35.1-not reached). Survival projections suggest that amivantamab plus lazertinib could extend median OS to more than a year beyond that achieved with osimertinib. At three years, 61 percent of patients treated with the combination were alive compared with 53 percent of those receiving osimertinib."

P3 data • Non Small Cell Lung Cancer

Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Myung-Ju Ahn | Trial completion date: Jul 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

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

Patient-derived glioblastoma organoids enable prediction of drug response and identification of therapeutic candidates in glioblastoma (SNO 2025) - "Temozolomide (TMZ) is the only approved first-line therapy, but frequent resistance limits its efficacy, highlighting the urgent need for alternative treatments...To explore alternative therapeutic options, we screened FDA-approved drugs and identified lazertinib, a third-generation EGFR inhibitor, as a promising candidate for GBM...Its efficacy was further validated in vivo using patient-derived organoid xenograft models, which demonstrated a marked decrease in tumor mitotic activity. These findings underscore the potential of GBO-DST as a robust platform for personalized drug screening, advancing patient-specific GBM treatment strategies."

Clinical • Brain Cancer • Glioblastoma • Solid Tumor • MGMT

Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. (PubMed, J Clin Oncol) - "In participants with atypical EGFR-mutated advanced NSCLC, amivantamab-lazertinib demonstrated clinically meaningful antitumor activity with no new safety signals."

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

According to IQVIA, a pharmaceutical market research firm, Tagrisso and Leclaza recorded sales of 65.2 billion won ($44.4 million) and 26.3 billion won respectively in the third quarter. (Korea Biomedical Review)

Sales • Non Small Cell Lung Cancer

First-line treatment in EGFR-mutated non-small cell lung cancer: brief report of an individual patient data comparison of phase 3 clinical trials. (PubMed, Lung Cancer) - "In the ITT population, we found no differences in OS between amivantamab-lazertinib and osimertinib-chemotherapy, despite a slightly higher PFS of the latter. Osimertinib-chemotherapy could be more effective in patients with CNS metastases, without liver metastases, and EGFR L858R mutation, however we could not compare OS in these subgroups. Due to the indirect nature of the comparison and the limitation of the methods our results are not definitive, but rather hypothesis-generating. Other factors must be considered in the choice of the treatment, including patient's characteristics, the safety profile of the combinations, and center's facilities and expertise."

Journal • P3 data • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Patient-derived glioblastoma organoids enable prediction of drug response and identification of therapeutic candidates in glioblastoma (WFNOS 2025) - "Temozolomide (TMZ) is the only approved first-line therapy, but frequent resistance limits its efficacy, highlighting the urgent need for alternative treatments...To explore alternative therapeutic options, we screened FDA-approved drugs and identified lazertinib, a third-generation EGFR inhibitor, as a promising candidate for GBM...Its efficacy was further validated in vivo using patient-derived organoid xenograft models, which demonstrated a marked decrease in tumor mitotic activity. These findings underscore the potential of GBO-DST as a robust platform for personalized drug screening, advancing patient-specific GBM treatment strategies."

Clinical • Brain Cancer • Glioblastoma • Glioma • Solid Tumor • MGMT

Oscotec moves to convert Genosco into 100% subsidiary to secure funding for drug trials (Chosun Biz) - "Drug developer Oscotec has begun work to make Genosco a 100% subsidiary. Genosco developed the lung cancer drug Leclaza, the first domestically developed anticancer drug to enter the U.S. market....Oscotec holds 59% equity in Genosco. Oscotec plans to secure funds through a third-party paid-in capital increase and buy the remaining 41% equity. It plans to newly issue and sell shares to specific external investors who are not existing shareholders."

Commercial • Non Small Cell Lung Cancer

Janssen Korea, the Korean pharmaceutical division of Johnson & Johnson (J&J), announced on November 10 that it will collaborate with Yuhan Corporation to co-promote the Rybrevant (amivantamab) + Leclaza (lazertinib) combination therapy in South Korea. (BioNews) - "The two companies signed an agreement on October 31, formalizing their partnership to co-promote the combination therapy....Under this new agreement, J&J will collaborate with Yuhan Corporation to co-promote the combination therapy in Korea....Johnson & Johnson will remain responsible for the distribution of Rybrevant, while Yuhan Corporation will oversee the distribution of Leclaza."

Licensing / partnership • Non Small Cell Lung Cancer

Assessing first-line treatment for advanced EGFR-mutated NSCLC in diverse clinicopathological subgroups: a systematic review and network meta-analysis. (PubMed, BMC Cancer) - "This NMA revealed that cases with EGFR-mutated NSCLC may benefit from different first-line treatment regimens according to their clinicopathological characteristics. On the whole, osimertinib plus CT and amivantamab plus lazertinib emerged as the most noticeable treatment modalities for such cases. (PROSPERO ID: CRD42024506995)."

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

Time toxicity in previously untreated metastatic or unresectable epidermal growth factor receptor-mutant non-small cell lung cancer: a clinical practice review. (PubMed, Transl Lung Cancer Res) - "Overall, the estimated time toxicity was 1.03 days for the osimertinib-only group (FLAURA), 3.635 days for the osimertinib plus chemotherapy group (FLAURA2), and 6.425 days for the amivantamab plus lazertinib group (MARIPOSA). Our findings highlight a significant increase in healthcare burden with combination strategies compared to osimertinib monotherapy, underscoring the need for further research to balance time toxicity with the benefits of survival associated with each regimen."

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

Efficacy and safety analysis of treatment in patients with EGFR-mutated advanced NSCLC who progressed on TKIs: a systematic review and meta-analysis. (PubMed, Front Immunol) - "In the network meta-analysis (NMA), amivantamab plus lazertinib plus chemotherapy (amiva-lazer-chemo) yielded the highest PFS (surface under the cumulative ranking curve [SUCRA]: 0.88; hazard ratio [HR] vs chemotherapy, 0.44; 95% CI, 0.32-0.61), followed by AK112 plus chemotherapy (SUCRA: 0.79; HR, 0.46; 95% CI, 0.32-0.67). Combination therapy with anti-angiogenic agents also represents a viable treatment strategy for this patient population. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024565403."

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

First-Line Third-Generation EGFR Tyrosine Kinase Inhibitor Monotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, MedComm (2020)) - "Osimertinib (HR, 0.90; 95% CrI, 0.83-0.99) and lazertinib (HR, 0.89; 95% CrI, 0.79-1.00) showed overall survival benefits over first-gen TKIs. Furmonertinib, aumolertinib, and osimertinib had lower rates of severe treatment-related adverse events (TRAEs), while befotertinib exhibited the highest risk of grade ≥3 TRAEs (RR, 3.96; 95% CrI, 2.35-7.17). This study is the first head-to-head comparison of third-gen EGFR-TKIs using a Bayesian network meta-analysis, offering critical insights into efficacy and safety. Our results support personalized selection of third-gen EGFR TKIs for patients with advanced EGFR-mutated NSCLC, particularly for subpopulations with CNS metastases or different mutation subtypes."

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

Phase II study of lazertinib and pemetrexed in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer with leptomeningeal metastases: the KCSG LU 21-01, LAZARUS study. (PubMed, Lung Cancer) - "Lazertinib plus pemetrexed demonstrated promising intracranial efficacy, OS benefits, and improved quality of life, highlighting its potential as a treatment option for EGFR-mutant NSCLC and LM, particularly in previously treated patients."

Journal • P2 data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • EGFR

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Non-Small Cell Lung Cancer, Version 1.2026. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

Optimizing lazertinib therapy through GSTM1 genotyping: a strategy to reduce excess drug exposure and potential toxicity. (PubMed, Cancer Chemother Pharmacol) - "Our findings support the feasibility of individualized lazertinib dosing based on GSTM1 status to reduce toxicity and healthcare costs without compromising effective exposure."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • GSTM1

In the 2026 version of the National Cancer Network (NCCN) guidelines for non-small cell lung cancer (NSCLC) released on the 6th...Lazcluze and Janssen’s "Rybrevant" combination therapy was officially listed as "the most recommended first-line treatment option (Preferred, Category 1)." (Maeil Business Newpaper) - "The update is interpreted as reflecting the positive results of the phase 3 clinical trial 'MARIPOSA'."

NCCN guideline • Non Small Cell Lung Cancer

Preventing Moderate to Severe Dermatologic Adverse Events in First-line EGFR-mutant Advanced NSCLC Treated with Amivantamab Plus Lazertinib: Early Success of the COCOON Trial (DGHO 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 & feet QD, & non-comedogenic ceramide-based moisturizer to body & face QD... With the simple, widely available, and easy to use COCOON DM regimen, ~2 out of every 3 pts did not experience any moderate to severe dermatologic AEs, and incidence of these skin AEs was reduced by 50% vs SoC DM. This regimen supported pts treatment with 1L ami + laz by reducing ami discontinuations due to AEs by ~50%."

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