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

A Single-Arm Phase 2 Study of First-Line Amivantamab, Lazertinib, Pemetrexed in EGFR-mutant NSCLC: AMIGO-1 (LACOG 0821) (IASLC-WCLC 2026) - P2 | "A one-group chi-square test (one-sided alpha = 0.10) had 80% power to detect improvement from 50% (historical osimertinib - standard therapy when AMIGO-1 was designed) to 65% with 49 pts. Toxicity may have limited overall benefit. These findings support further evaluation of AMI+L+ pemetrexed, especially in poor prognostic pts."

Clinical • P2 data • Febrile Neutropenia • Infectious Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pancreatitis • Solid Tumor • EGFR • TP53

Subcutaneous Amivantamab+Lazertinib With Supportive Care in EGFRm NSCLC: Longer Follow-Up From the Pragmatic COPERNICUS Study (IASLC-WCLC 2026) - P2 | "Introduction : Intravenous amivantamab plus lazertinib significantly prolonged overall survival versus osimertinib (HR, 0.75; P =0.005) in first-line common EGFR -mutant ( EGFR m) advanced NSCLC in MARIPOSA. Reductions were observed in ARRs, rash, VTE, and AE-associated amivantamab discontinuations, despite an older population than MARIPOSA. These results demonstrate that early supportive care and subcutaneous administration Q4W can improve patient experience of amivantamab plus lazertinib in a clinical practice setting, supporting its broad use as first-line therapy."

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

Improving prevention of moderate to severe dermatologic adverse events in EGFR-mutant advanced NSCLC treated with first-line (1L) subcutaneous (SC) amivantamab + lazertinib: First results from a new COCOON cohort (ESMO 2026) - No abstract available

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

SKIPPirr: Premedication to Reduce Amivantamab Associated Infusion Related Reactions (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2027 ➔ Sep 2027

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

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 completion date: Dec 2026 ➔ Dec 2027

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

Health-Related Quality of Life and Cost-Effectiveness of First-Line Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Monotherapy in Advanced EGFR-Mutated Non-small Cell Lung Cancer: A Systematic Review. (PubMed, Cureus) - "Afatinib and aumolertinib were considered cost-effective within the settings examined, whereas osimertinib, dacomitinib, and lazertinib exceeded the willingness-to-pay thresholds used in the respective analyses. In contrast, cost-effectiveness varied markedly across healthcare systems and appeared to be largely driven by drug acquisition costs and country-specific willingness-to-pay thresholds. The principal value distinction among first-line EGFR-TKIs may therefore lie less in global HRQoL and more in whether additional clinical benefit is considered affordable within the local healthcare setting."

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

RIT1 Mutated Metastatic Lung Adenocarcinoma - a Case Series (IASLC-WCLC 2026) - "He received Gamma Knife-Stereotactic Radiosurgery (GK-SRS) followed by pembrolizumab, but immune-related toxicities and new brain metastases prompted pembrolizumab discontinuation after six months. He remains alive on maintenance pemetrexed 24 months after diagnosis...She enrolled in the MARIPOSA clinical trial, lazertinib/placebo and osimertinib/placebo...She then commenced Atezolizumab-Bevacizumab-Carboplatin-Paclitaxel (ABCP). Following further pulmonary metastases and progression on docetaxel, she developed cauda equina, necessitating EBRT...She received erlotinib followed by osimertinib...Conclusions : This case series underscores the critical need for comprehensive molecular profiling, as RIT1 mutations may confer resistance across standard LUAD treatments. Prospective studies are required to validate the prognostic/predictive value of clinically relevant mutations in LUAD."

Clinical • IO biomarker • Metastases • Tumor mutational burden • Hepatocellular Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ARID1A • PIK3CA • RIT1 • TMB

Subcutaneous amivantamab plus lazertinib has shown long-term, clinically meaningful and durable antitumor efficacy for patients with previously untreated, EGFR-mutated, advanced…NSCLC, according to long-term findings from the PALOMA-2 trial presented in a poster at the 2026 World Conference on Lung Cancer (Cancer Therapy Advisor) - "The median follow-up was 33.1 months as of the July 2026 data cutoff. The median overall survival (OS) was not reached. The median OS rate was 83% at 24 months and 70% at 36 months....Data from cohorts 1, 5 and 6 were presented at WCLC 2026....The investigator-assessed median progression-free survival was 26.1 months. At 24 months, 56% of patients were progression-free, and at 36 months 37% were progression-free. The objective response rate was 90%. Twenty patients (9%) had complete responses and 171 (81%) patients had partial responses. The median duration of response among confirmed responders (n=163) was 25.6 months. At the data cutoff, 50% of patients had an ongoing response."

P2 data • Non Small Cell Lung Cancer

Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Primary results from the phase 3 MARIPOSA-2 study. (PubMed, Ann Oncol) - "Amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy improved progression-free survival and intracranial progression-free survival versus chemotherapy in a population with limited options after disease progression on osimertinib. Longer follow-up is needed for the modified amivantamab-lazertinib-chemotherapy regimen."

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

A phase 2b study of subcutaneous amivantamab with lazertinib as first-line treatment, or with chemotherapy as second-line treatment, for EGFR-mutated non-small cell lung cancer (NSCLC): COPERNICUS (AACR 2025) - P2 | "In Cohort 1, participants must not have received any prior systemic therapy and will receive SC amivantamab and oral lazertinib; in Cohort 2, participants must have had disease progression after EGFR-TKI monotherapy and will receive SC amivantamab and chemotherapy (carboplatin-pemetrexed). COPERNICUS aims to evaluate the efficacy and safety of SC amivantamab regimens using a pragmatic study design to enroll participants with diverse backgrounds and combine advancements in supportive care to prevent and proactively manage AEs."

Clinical • P2b data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

MARIPOSA-2: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure (clinicaltrials.gov) - P3 | N=776 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2027 ➔ Jul 2028

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

Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy in Relapsed/Refractory EGFR-mutant NSCLC (IASLC-WCLC 2022) - P1 | " The LACP (lazertinib, amivantamab, carboplatin, pemetrexed) cohort of the CHRYSALIS-2 study (NCT04077463) enrolled patients with EGFR-mutant NSCLC whose disease progressed on or after treatment with an EGFR TKI as last line of therapy (maximum of 3 prior lines)... Enrolled patients have received a median of 2 (range, 1-3) prior lines of therapy, including osimertinib (n=14), gefitinib (n=3), and afatinib (n=3)... Amivantamab in combination with lazertinib and chemotherapy yielded high overall response rates in patients who progressed on EGFR TKIs as prior line of therapy. The safety profile of the LACP regimen was consistent with the individual agents, with no evidence of new safety signals or additive toxicity."

Combination therapy • Fatigue • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • 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

Amivantamab plus chemotherapy (with or without lazertinib) vs chemotherapy in EGFR-mutated advanced NSCLC after progression on osimertinib: MARIPOSA-2, a phase III, global, randomized, controlled trial (ESMO 2023) - P3 | "Background Amivantamab (ami), an EGFR-MET bispecific antibody with immune cell-directing activity, plus carboplatin-pemetrexed (chemo) with and without lazertinib (laz), a CNS-penetrant, 3rd-gen EGFR TKI, have demonstrated antitumor activity in phase 1 studies. The impact of modifying the ami-laz-chemo regimen on safety and efficacy requires longer follow-up. Conclusions Ami-chemo and ami-laz-chemo improved PFS, ORR, and intracranial PFS vs chemo in EGFR-mutated advanced NSCLC after progression on osi and may represent a new standard of care."

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

Overall survival of first-line amivantamab plus lazertinib in atypical EGFR-mutated advanced non-small cell lung cancer (NSCLC): Updated results from the CHRYSALIS-2 study. (ASCO 2026) - P1 | "Afatinib, approved for atypical EGFR-mutated NSCLC, showed a median overall survival (OS) of 19.4 months among 38 participants (pts) with atypical EGFR-mutations globally (Yang Lancet Oncol 2015)...In MARIPOSA, first-line (1L) ami plus lazertinib (ami-laz) significantly prolonged OS vs osimertinib (HR, 0.75; P=0.005) in cEGFR-mutated NSCLC... 1L treatment of atypical EGFR-mutated advanced NSCLC with ami-laz resulted in a clinically meaningful median OS of nearly 3.5 years. Many pts were able to stay on 1L treatment long term, with 20% still ongoing. Ami-laz has now shown substantial survival benefit in both 1L cEGFR- and atypical EGFR-mutated disease."

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

Second versusThird-Generation EGFR-TKIs as Frontline Treatment for EGFR-Mutant NSCLC: Interim Results From Korean EGFR Registry (IASLC-WCLC 2026) - "Among 1,954 total enrolled patients, we analyzed 1,198 patients with metastatic or recurrent disease treated with either 2G (n=701; afatinib [n=597] or dacomitinib [n=104]) or 3G TKIs (n=497; osimertinib [n=155] or lazertinib [n=342]) as frontline therapy. However, 3G EGFR-TKIs provide superior initial disease control (PFS and TTF) compared to 2G TKIs. Due to the relatively short follow-up period of the 3G group (16.9 months), more mature data are required to confirm long-term survival outcomes and the optimal treatment sequence in EGFR-mutant NSCLC."

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • PD-L1

Amivantamab, lazertinib and bevacizumab in EGFR-mutant advanced NSCLC with acquired resistance to 3rd generation EGFR-TKI: Final results from the phase II ETOP AMAZE-lung trial (ELCC 2025) - P2 | "Amivantamab (ami), an EGFR-MET bispecific antibody, is approved in combination with chemotherapy for EGFR-mutant NSCLC patients (pts) after progression on osimertinib (osi) based on the MARIPOSA-2 trial. Ami-laz-bev combination demonstrated durable antitumour activity and represents a promising chemo-sparing alternative after progression on osi. Safety was consistent with known toxicity profiles."

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

Pivotal topline data from the phase 1/2 TRIDENT-1 trial of repotrectinib in patients with ROS1+ advanced non-small cell lung cancer (NSCLC) (AACR-NCI-EORTC 2022) - P1/2 | "He played a monumental role in developing repotrectinib, lazertinib, amivantamab, and other targeted- and immuno-therapies, many of which were acknowledged for breakthrough therapy designation and FDA approval. Repotrectinib achieves durable activity, including intracranial responses, in TKI-naïve and TKI-pretreated patients with ROS1+ advanced NSCLC, and those with ROS1 G2032R. Repotrectinib safety is well characterized, manageable, and compatible with long-term use."

Clinical • Late-breaking abstract • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Comparative Efficacy of Subsequent Therapies After Progression on 3rd-Gen EGFR-TKIs: Systematic Review & IPD Meta-Analysis (IASLC-WCLC 2026) - "However, with theemergence of novel biomarker-guided and unguided strategies—including METamplification-guided osimertinib plus savolitinib, a PD-1/VEGFA bispecificantibody plus chemotherapy, an EGFR/c-Met bispecific antibody plus lazertinibplus chemotherapy, TROP2-ADC, and TROP2-ADC plus osimertinib—whether efficacydiffers by use of MET amplification as a predictive biomarker remains unknow. Conclusions : In head-to-head studies,MET-directed therapy showed a trend toward PFS improvement but does nottranslate into OS benefit. TROP2-ADC shows significant OS benefit and thehighest 12-month OS rate."

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

Subcutaneous amivantamab and lazertinib as first-line treatment in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Results from the phase 2 PALOMA-2 study. (ASCO 2024) - P2 | "IV ami + lazertinib (laz), a 3 rd -generation EGFR TKI, demonstrated superior progression-free survival (PFS) in patients (pts) with treatment-naïve, advanced EGFR-mutated NSCLC vs osimertinib (Cho AnnOncol 2023). SC ami+laz showed a response rate similar to historic IV ami+laz in first-line EGFR-mutated NSCLC, with an improved safety profile that included significantly lower ARR rates. Further, prophylactic anticoagulation can be safely implemented and reduced incidence of VTE."

Clinical • Late-breaking abstract • Metastases • P2 data • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism • EGFR

BRAINTOX: uremic toxins in chemotherapy response in the brain (EANO 2026) - "Then, U87MG cells were co-treated with p-cresyl sulfate or indoxyl sulfate and ten selected drugs in a drug screening platform (drugs: Temozolamide, Dacomitinib, Selinexor, Panobinostat, Ixazomib, AMG232, Bortezomib, Lazertinib, Temsirolimus, Carmilzomib). The uremic toxins p-cresyl sulfate and indoxyl sulfate were enriched in brain tumor tissue samples of IDH wt patients compared to IDH mut patients, validating the findings of the discovery cohort. IDH wt patients have higher levels of uremic toxins in the circulation compared to patients with IDH mutant adult-type diffuse gliomas and the toxins reach the tumor site. Further experiments shall elucidate the mechanism by which uremic toxins reach the tumor cells and whether they modulate drug responsiveness."

Brain Cancer • Diffuse Glioma • Glioblastoma • Glioma • Oncology • Solid Tumor

Real-World Characteristics and Treatment Patterns of EGFR-mutant Non-Small Cell Lung Cancer: Korean EGFR Registry (IASLC-WCLC 2026) - "Afatinib (38.3%) and lazertinib (32.5%) were the most frequently used agents, followed by osimertinib (12.7%), and gefitinib (9.7%), while chemotherapy alone was infrequently administered (1.0%). Conclusions : This prospective interim analysis of a large nationwide registry provides a comprehensive overview of real-world clinical characteristics, genomic profiles, and treatment patterns of EGFR-mutant NSCLC in Korea. These findings provide important context for future outcome-based and comparative effectiveness studies."

Clinical • IO biomarker • Real-world • Real-world evidence • Diabetes • Hypertension • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Amivantamab in combination with lazertinib in patients with atypical epidermal growth factor receptor (EGFR) mutations excluding exon 20 insertion mutations: Initial results from CHRYSALIS-2 (ESMO Asia 2022) - P1 | "Afatinib is the only EGFR tyrosine kinase inhibitor (TKI) approved to treat these mutations. No new safety signals or concerns were identified. Conclusions Among a patient population with few treatment options, amivantamab combined with lazertinib demonstrated encouraging anti-tumor activity in a majority of patients with a tolerable safety profile."

Clinical • Combination therapy • EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Operationalizing the PMMR Standardized Framework to Manage Patients on TKIs for Non-Small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2026) - "Firstly, TA AE data was collected (Osimertinib, Amivantamab-Lazertinib, Sunvozertinib, Crizotinib, Alectinib, Afatinib, Entrectinib, Selpercatinib, Lorlatinib) based on clinical trial data, regulatory drug labels, and provincial/national guidelines. Details, including barrier and facilitators, and recommendations on implementation will be presented at the conference. Conclusions : To further enhance adherence and treatment efficacy, future directions include: (i) integrating a grading criterion for nurses in the EMR while using the scripts to enhance assessment and (ii) creating a remote monitoring application that leverages PMMR."

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

Subcutaneous versus Intravenous Amivantamab, both in Combination with Lazertinib, in Refractory EGFR-mutated NSCLC: Primary Results from the Phase 3 PALOMA-3 Study. (PubMed, J Clin Oncol) - "Subcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced infusion-related reactions, increased convenience, and prolonged survival."

Combination therapy • Journal • P3 data • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism • EGFR