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

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

Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial. (PubMed, J Thorac Oncol) - P2 | "An uncomplicated, widely available, prophylactic regimen (COCOON DM) reduced the incidence of DAEIs with amivantamab-lazertinib and the impact of symptoms on QoL."

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

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

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

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

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 (ELCC 2025) - P2 | "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 • Oncology • Solid Tumor • EGFR

Lazertinib for patients with NSCLC harboring uncommon EGFR mutations: A phase II multi-center trial. (PubMed, J Thorac Oncol) - "Lazertinib demonstrated promising efficacy and a manageable safety profile in NSCLC patients with uncommon EGFR mutations, particularly for G719X, S768I, and L861Q subtypes. These results suggest lazertinib could be an effective treatment option for this heterogeneous patient population with limited therapeutic alternatives."

Journal • P2 data • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • EGFR

PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC (IASLC-WCLC 2025) - P2 | "In MARIPOSA (median follow-up, 22.0 months), intravenous amivantamab administered every 2 weeks (Q2W) plus lazertinib significantly prolonged progression-free survival (PFS) versus osimertinib (hazard ratio, 0.70; P <0.001). Conclusions : In participants with EGFR- mutated advanced NSCLC, first-line treatment with subcutaneous amivantamab Q4W plus lazertinib showed a response rate similar to historical intravenous amivantamab Q2W data with fewer ARRs; incidence of VTEs was low with prophylactic anticoagulation. The subcutaneous amivantamab Q4W regimen will potentially further improve patient convenience and overall treatment experience."

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

Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA (IASLC-WCLC 2025) - "In this updated analysis, significantly lower rates of EGFR and MET resistance alterations were seen in the amivantamab-lazertinib arm vs osimertinib. These findings further suggest that amivantamab-lazertinib, with its statistically significant and clinically meaningful survival benefit over osimertinib, is changing the underlying biology of EGFR -mutant disease."

Clinical • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. (PubMed, N Engl J Med) - P3 | "Amivantamab-lazertinib led to significantly longer overall survival among participants with previously untreated EGFR-mutated advanced NSCLC than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.)."

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

Validation Analysis of MET IHC as a Biomarker for Amivantamab-Lazertinib Response in Post-Osimertinib EGFR-Mutated NSCLC (IASLC-WCLC 2025) - P1 | "Nevertheless, amivantamab alone or with other agents is efficacious for advanced/metastatic NSCLC. Additional results will be reported at the meeting."

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

Poland Becomes Second Country After Germany to Cover Leclaza Under National Health Insurance (The Asia Business Daily) - "According to industry sources on March 23, Poland's Ministry of Health announced a new reimbursement drug list effective April 1, 2026, which includes Leclaza among the newly covered medicines. As a result of this announcement, Leclaza will be covered by national insurance starting next month. The reimbursement applies to first-line treatment for adult patients with non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletion or exon 21 substitution mutations. It also includes combination therapy with Janssen’s bispecific antibody treatment Rybrevant."

Reimbursement • Non Small Cell Lung Cancer

Decoding First-line strategies in EGFR-mutated NSCLC: A Computational Analysis of FLAURA2 vs. MARIPOSA (IASLC-TTLC 2025) - "Using the IPDfromKM method we found superior efficacy of osimertinibchemotherapy in comparison to amivantamab-lazertinib for patients with advanced EGFRm NSCLC, including high risk cohorts. As we await randomized studies to compare these strategies, here we demonstrate the potential of such computational analysis to aid in clinical decision making, especially in settings where multiple treatment options are currently approved. Figures: Not to be submitted with abstract, will include in poster."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Amivantamab plus lazertinib vs osimertinib in first-line (1L) EGFR-mutant (EGFRm) advanced NSCLC: Final overall survival (OS) from the phase III MARIPOSA study (ELCC 2025) - P3 | "Ami+laz is the first and only treatment to significantly reduce the risk of death vs osi in pts with 1L EGFRm advanced NSCLC. While the median has not yet been reached for ami+laz, it is expected to provide an OS benefit of at least 12 mo. These results further establish ami+laz as a new SoC in this population."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Consolidative lazertinib following chemoradiotherapy in unresectable stage III EGFR-mutated NSCLC: Preliminary results from the phase II PLATINUM trial (ELCC 2026) - P2 | "Background While durvalumab consolidation after concurrent chemoradiotherapy (CCRT) is the standard for unresectable stage III non-small cell lung cancer (NSCLC), its efficacy in the EGFR-mutated (EGFRm) subgroup remains suboptimal. Although the phase III LAURA trial recently established the role of osimertinib in this setting, evidence for other third-generation EGFR tyrosine kinase inhibitors is still evolving...Five deaths occurred, all of which were assessed as unrelated or unlikely to be related to lazertinib.Conclusions In this preliminary analysis, consolidative lazertinib demonstrated promising clinical activity with a manageable safety profile in patients with unresectable stage III EGFRm NSCLC. No new safety signals were observed, supporting the potential of lazertinib as a viable consolidation strategy in this population."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

LEPIDOPTERA: A prospective, multi-cohort, multi-country, observational study of clinical outcomes in patients with EGFR-mutant (EGFRm), advanced NSCLC treated with approved amivantamab (ami)-containing regimens in routine clinical practice (ELCC 2026) - P | "Data will be analysed from two patient cohorts who have received ≥1 dose of ami within an ami-containing regimen: (B) plus carboplatin and pemetrexed in patients who have progressed after prior therapy including an EGFR-TKI; (C) plus lazertinib as first-line treatment. Exploratory endpoints include RW clinical outcomes per disease/patient characteristics, ami dosing regimen/formulation (IV/SC), along with tt intracranial progression, and subsequent treatment patterns. Recruitment started in November 2025, and study completion is estimated for November 2031."

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

Clinical outcomes and molecular characterization of patients with uncommon EGFR-mutated NSCLC: A single-centre study (ELCC 2026) - "MPFS for osimertinib (osi) or lazertinib (lazer) monotherapy (n=27), osi + chemotherapy (n=4) and afatinib (n=3) were 10.0 mo (95% CI 6.2–30.3), 9.0 mo (95% CI 4.2–NR) and 16.7 mo (95% CI 12.9–NR), respectively. MPFS was not reached with amivantamab + lazer (n=3), chemotherapy ± immunotherapy (n=6) and zipalertinib (n=1). Progression occurred at 1.5 mo in one patient treated with sunvozertinib.Conclusions This real-world cohort provides broad clinical and molecular characterization of uncommon EGFR-mutated NSCLC and supports the need for dedicated prospective trials."

Clinical • Clinical data • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Real-world outcomes on first-line osimertinib in EGFR-mutant NSCLC: Analysis of prognostic factors influencing overall survival (ELCC 2026) - "Background Recently, two combination strategies—osimertinib plus chemotherapy and amivantamab plus lazertinib—have demonstrated improved efficacy compared with osimertinib alone. Baseline performance status remains the main determinant of OS. A favorable prognostic subgroup achieves prolonged survival with monotherapy, supporting its use as a low-toxicity option in selected patients."

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

Results from a global physician based survey on factors guiding treatment decision making in a changing first-line EGFRm advanced NSCLC landscape (ELCC 2026) - "In addition to osimertinib (osi), combination therapies of osi + platinum pemetrexed chemotherapy (osi + plat pem) and amivantamab + lazertinib (ami + laz) are available. The top 5 attributes guiding tx selection of an ideal 1L tx for EGFRm aNSCLC pts were overall survival (73%), progression free survival (60%), high response rates (37%), low incidence of serious/severe side effects (32%), and quality of life (31%).Conclusions Physicians are familiar with emerging txs for EGFRm aNSCLC and prioritize factors related to effectiveness and, secondarily, factors related to tolerability, and quality of life when considering an ideal tx. At the time of analysis, physicians anticipated using osimertinib based regimens most often in the 1L, but emerging OS data for txs may influence future decisions."

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

Estimated time toxicity associated with 1L use of 3rd gen EGFR TKI regiments in advanced non-small cell lung cancer in the European Union (ELCC 2026) - "The objective of this study was to estimate the time toxicity (TT) for patients associated with approved 1L treatments for EGFRm NSCLC over the first year of treatment in the European Union (EU).Methods This model estimates TT over the first year of treatment for osimertinib (osi), osimertinib + platinum pemetrexed chemotherapy (osi + plat pem), amivantamab + lazertinib (ami + laz) intravenous (IV), and ami + laz subcutaneous (SQ)...The largest difference between osi based regimens and ami + laz based regimens was prophylactic time with osi at 0 hours, osi + plat pem at 7 hours, and both ami + laz regimens at 219 hours. We estimate that SQ ami + laz will reduce drug administration time from 67 hours to 20 hours per year but will not impact prophylactic time.Conclusions It is important to consider time toxicity and overall treatment burden when discussing a patient's treatment goals, because our model estimates that there may be substantial differences in time..."

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

First-line subcutaneous amivantamab plus lazertinib in EGFR-mutated advanced NSCLC: Updated results from the PALOMA-2 study (ELCC 2026) - P2 | "In MARIPOSA, first-line (1L) IV ami plus lazertinib (ami-laz) demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS; HR, 0.75; P=0.005), with the median OS improvement projected to exceed 1 year vs osimertinib (Yang NEJM 2025)...Based on data maturity, pooled data (n=135) including additional pts who received 1L SC ami-laz from Cohort 6 may be presented at the meeting.Conclusions SC ami-laz as 1L tx of EGFR-mutated advanced NSCLC demonstrated long-term durable outcomes and a safety profile consistent with MARIPOSA. SC ami further improves the overall tx experience, allowing pts to remain on tx longer."

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

Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. (ASCO 2024) - P3 | "PALOMA-3 (NCT05388669) evaluated SC ami+laz vs IV ami+laz for pharmacokinetics (PK), efficacy, and safety among pts with EGFR Ex19del or L858R-mutated advanced NSCLC and disease progression on osimertinib and platinum-based chemotherapy. SC ami demonstrated noninferior PK and ORR compared to IV. Unexpectedly, DoR, PFS, and OS were longer in the SC arm vs IV, suggesting that the route of administration or formulation may affect outcomes. The safety profile was improved for SC ami, with lower IRR and VTE rates."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EGFR-TKI enhances anti-CD47 antibody-mediated macrophage phagocytosis in EGFR-mutant non-small cell lung cancer (AACR 2026) - "Lazertinib induces CD47 upregulation and synergizes with IMC-002 to enhance macrophage-mediated clearance of EGFR-mutant NSCLC cells. These findings provide a mechanistic rationale for clinical evaluation of EGFR-TKI and anti-CD47 combination strategies to improve therapeutic efficacy in EGFR-mutant lung cancer."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD47 • SIRPA • TGFB1

Impact of first-line (1L) amivantamab-lazertinib vs osimertinib on second-line (2L) progression-free survival (PFS) (AACR 2026) - "Abstract is embargoed at this time."

Clinical • Late-breaking abstract • Oncology

Intra-tumoral Porphyromonas gingivalis mediates osimertinib resistance in EGFR-mutant lung adenocarcinoma through gingipain-mediated IGF1R activation (AACR 2026) - "The equilibrium binding constants (Kd) for IGF1R binding to Kgp and RgpA were determined to quantify the strength of their non-covalent, reversible protein-protein interactions. Infection with Pg significantly decreased the sensitivity of multiple EGFR-mut LUAD to EGFR-TKIs including osimertinib and lazertinib in both human and mouse EGFR-mutant lung cancer cells through activation of the IGF1R pathway. Pg, commonly identified within LUAD tissues, induces EGFR-TKI resistance in EGFR-mut LUAD via Pg gingipain-dependent activation of IGF1R. Gingipains directly interact with IGF1R, revealing a new bacterium-tumor crosstalk mechanism that promotes drug resistance and suggesting potential therapeutic benefits of targeting bacterial enzymes or the IGF1R pathway. Additional studies on the effect of Pg on EGFR-TKI response in humans are needed."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CASP3 • EGFR • IGF1R