gefitinib / Generic mfg. - LARVOL DELTA

A Phase III Randomized Multicenter Trial of Adjuvant Gefitinib Plus Chemotherapy Versus Chemotherapy in EGFR-Mutant NSCLC (IASLC-WCLC 2026) - "Introduction : Approximately 30% of patients with surgically resected non-small cell lung cancer (NSCLC) experience recurrence. The benefit appeared greater in exon 19 deletion than in L858R disease, with manageable toxicity. In the era of adjuvant osimertinib, longer follow-up and further minimal residual disease (MRD) analyses are warranted to clarify the role of TKI- and/or chemotherapy-based adjuvant treatment."

Clinical • P3 data • Dermatitis • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Timosaponin AⅢ and Gefitinib Synergistically Inhibit NSCLC by Targeting RAGE/AKT/NF-κB/VEGF Pathway. (PubMed, Curr Cancer Drug Targets) - "This study not only provides sufficient preclinical in vitro and in vivo pharmacological evidence for the synergistic anti-tumor effect of Tim-AⅢ and GEF, but also clarifies its new mechanism of action through two pathways-EMT and angiogenesis. This provides theoretical support for the development of new combined drug regimens in clinical practice."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH1 • VIM

LENTIG-HCC: Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: First Affiliated Hospital of Wenzhou Medical University

New P2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Comprehensive Profiling of ac4C RNA Modification Identifies CERCAM in Cancer-Associated Fibroblasts as a Key Prognostic and Microenvironmental Regulator in Colorectal Cancer. (PubMed, Cancer Rep (Hoboken)) - "This study delineates the crucial role of ac4C modification in shaping the CRC microenvironment, identifies CERCAM as a CAF-specific driver of tumor progression, and provides a translational framework for ac4C-based prognostic prediction and personalized targeted therapy."

Biomarker • IO biomarker • Journal • Colorectal Cancer • Oncology • Solid Tumor • CAFs • CD14 • CD8 • LAG3 • SIRPA • TGFB1

Efficacy of EGFR-TKI Plus Antiangiogenics vs Anlotinib in EGFR-TKI-Resistant NSCLC. (IASLC-WCLC 2026) - "Treatments were: EGFR-TKI+anlotinib (n=30), EGFR-TKI+bevacizumab (n=29), or anlotinib monotherapy (n=21)...Preclinical studies used the gefitinib-resistant PC-9/GR cell line and a xenograft model...Conclusions : Continuing EGFR-TKI with an anti-angiogenic agent is more effective than anlotinib monotherapy for EGFR-TKI-resistant NSCLC. The synergistic effect is mainly achieved by simultaneously inhibiting multiple pathways, thereby inhibiting tumor cell proliferation and promoting tumor cell apoptosis."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • BCL2 • CASP3 • CCND1 • CDK4

Randomized Phase III Study of EGFR Tyrosine Kinase Inhibitor and Intercalated Platinum-doublet Chemotherapy for Non-small Cell Lung Cancer Harboring EGFR Mutation. (PubMed, Clin Cancer Res) - "The intercalation of cisplatin plus pemetrexed after the response to EGFR-TKI improved PFS but not OS compared with EGFR-TKI monotherapy as the first-line treatment for advanced NSqNSCLC harboring EGFR mutation."

Journal • P3 data • 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

Randomized phase 3 study of first-line AZD3759 (zorifertinib) versus gefitinib or erlotinib in EGFR-mutant (EGFRm+) non–small-cell lung cancer (NSCLC) with central nervous system (CNS) metastasis. (ASCO 2023) - P2/3 | "First-line AZD3759 demonstrated superior systemic and IC antitumor efficacy compared with first generation EGFR TKIs in pts with EGFRm+ NSCLC and CNS metastasis. Adverse events were as expected and manageable. IC antitumor activity."

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

Predicting Who Needs More Than TKI Monotherapy: A Machine Learning Risk Stratification Tool for Advanced EGFR-mutated NSCLC (IASLC-WCLC 2026) - "The training cohort (n=151) receiving 1st/2nd-generation TKIs (erlotinib, n=69; afatinib, n=65; gefitinib, n=17). The model, developed on 1st/2nd-generation TKI data, generalized to an osimertinib-treated cohort, supporting that predictors of poor response reflect aggressive tumor biology rather than generation-specific resistance. These findings suggest a generation-agnostic risk stratification framework that, if validated prospectively, could inform treatment escalation in the era of osimertinib as first-line standard of care."

Machine learning • Metastases • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CEACAM5 • EGFR

Facile and energy-efficient magnetic stirrer-assisted media milling enables drug-drug nano-cocrystals with synchronous and fast release. (PubMed, Int J Pharm) - "Gefitinib (GTB) and dasatinib (DAS) are two tyrosine kinase inhibitors with synergistic potential, but their poor and disparate solubility hinders fast and synchronous release in combination therapy. In vitro dissolution studies demonstrated that the nano-cocrystals integrated synchronous release and a high dissolution rate, achieving nearly 100% release of both drugs within 5 min. This work provides a facile, energy-efficient, and scalable platform for the development of compound formulations involving poorly water-soluble drugs."

Journal

Randomized Trial of Tepotinib Plus Gefitinib Versus Chemotherapy in EGFR-Mutant NSCLC with EGFR Inhibitor Resistance Due to MET Amplification: INSIGHT Final Analysis. (PubMed, Clin Cancer Res) - "Final analysis of INSIGHT suggests improved PFS and OS with tepotinib plus gefitinib versus chemotherapy in a subgroup of patients with MET-amplified EGFR-mutant NSCLC, after progression on EGFR inhibitors."

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

A phase III study comparing EGFR tyrosine kinase inhibitor (EGFR-TKI) monotherapy and EGFR-TKI with inserted cisplatin (CDDP) plus pemetrexed (PEM) as a first-line treatment in patients (pts) with advanced non-squamous non–small-cell lung cancer (NSqNSCLC) harboring EGFR activating mutation (EGFR-NSqNSCLC): JCOG1404/WJOG8214L, AGAIN study. (ASCO 2023) - "In the standard arm (SA), gefitinib (GEF) or osimertinib (OSI) was administrated until disease progression. In patients with advanced EGFR-NSqNSCLC, the insertion of platinum-doublet chemotherapy after the initial response to EGFR-TKI could not prolong OS compared with EGFR-TKI, though that could prolong PFS. Clinical trial information: UMIN000020242."

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

The role of KIAA1467 in breast cancer: insights from pan-cancer and single-cell sequencing analysis. (PubMed, Transl Cancer Res) - "Furthermore, high KIAA1467 expression corresponded to higher estimated IC50 values of cisplatin, gefitinib, paclitaxel and gemcitabine, consistent with reduced chemosensitivity observed in vitro. KIAA1467 participates in remodeling an immunosuppressive TME, correlates with malignant progression and chemoresistance, and may serve as a promising candidate target to optimize ICB-based combination therapy for BRCA. These findings offer new perspectives for the clinical treatment and comprehensive management of BRCA."

Journal • Breast Cancer • Oncology • Solid Tumor • BRCA

Gefitinib plus chemotherapy versus gefitinib alone in untreated patients with EGFR-mutated non–small cell lung cancer and brain metastases (GAP Brain): An open-label, randomized, multicenter, phase 3 study. (ASCO 2022) - P3 | "The eligible patients were randomly assigned (1:1) to receive gefitinib alone or gefitinib plus pemetrexed-platinum chemotherapy until intracranial progressive diseases, unacceptable adverse, or any cause of death. Inuntreated EGFR mutated NSCLC patients with brain metastases, gefitinib plus chemotherapy significantly improved intracranial PFS, PFS and a tendency of OS than gefitinib alone, and could be the optional first-line treatment."

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

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

Real-World Analysis of Co-Mutation Patterns and Their Clinical Outcomes in EGFR-Mutated Lung Cancer From Western India (IASLC-WCLC 2026) - "First-line systemic therapy was administered in 92.0% (n=173) mainly EGFR-TKIs-based regimens: gefitinib (43%),osimertinib (39.4%) & afatinib(13.4%) either as monotherapy(n=89)or in combination with chemotherapy (n=47) with ORR of 72.6%. mOS was 32.8 months (95% CI: 28.7-36.8) for EGFR+TP53 compared to 15.4 months (95% CI: 12.8-18.1) for EGFR+ALK (p=0.046); 24.3 months (95% CI: 12.4-36.1) for EGFR+ROS (p=0.526); and 20.2 months (95% CI: NA-NA) for EGFR+MET (p=0.693). Conclusions : Concurrent co-mutations in EGFR-mutated lung cancer significantly influence clinical outcomes, highlighting the critical role of comprehensive genomic profiling in optimizing personalized therapeutic strategies in real-world settings."

Clinical • Clinical data • IO biomarker • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • PIK3CA • TP53

Therapeutic mRNA vaccines for lung cancer: reshaping the tumor microenvironment to enhance anti-tumor immunity. (PubMed, Front Immunol) - "Traditional treatments for lung cancer include surgery, radiotherapy, chemotherapy, and targeted therapies (such as Erlotinib, Gefitinib, and Crizotinib), as well as immunotherapy (such as Nivolumab and Pembrolizumab). Against this background, this review systematically evaluates the current status and prospects of mRNA vaccines in lung cancer treatment, with a focus on their progress in precisely modulating the tumor microenvironment, identifying novel tumor antigens, discovering immune biomarkers, and related clinical studies. Additionally, the review discusses the process optimization of lipid nanoparticle (LNP) delivery systems, aiming to provide theoretical support and practical guidance for the development of safe and effective therapeutic vaccine platforms for lung cancer."

Biomarker • IO biomarker • Journal • Review • Infectious Disease • Lung Cancer • Novel Coronavirus Disease • Oncology • Solid Tumor

Phase Ib/II Trial of BRAF and EGFR inhibition in BRAFV600E metastatic colorectal cancer and other cancers: EVICT (Erlotinib and Vemurafenib In Combination Trial). (PubMed, Clin Cancer Res) - "The EVICT study demonstrated a safe and novel combination of two oral inhibitors targeting BRAF and EGFR. The dynamic assessment of serial ctDNA was a useful measure of underlying genomic changes in response to this combination and in undertsnidng potential mechanisms of resistance."

Journal • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS • MAP2K1 • MET • NRAS

Closing the Age Gap: Real-World Effectiveness and Tolerability of First-Line EGFR-TKIs in Elderly Patients With Advanced NSCLC (IASLC-WCLC 2026) - "First-line EGFR-TKIs included afatinib (62.5%), osimertinib (15.6%), gefitinib (15.6%), and erlotinib (6.3%). Outcomes in patients aged ≥70 years were comparable, supporting the use of EGFR-TKIs in carefully selected older patients. Toxicities were common but manageable, with a notable proportion requiring dose modification."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Gastrointestinal Disorder • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Solid Tumor

EGFR-TKIs plus Stereotactic Body Radiation Therapy (SBRT) for Stage IV Non-small Cell Lung Cancer (NSCLC): a prospective, multicenter, randomized, controlled phase II study. (PubMed, Radiother Oncol) - P2 | "The addition of SBRT significantly delayed the onset of acquired resistance to EGFR-TKIs and prolonged the PFS and OS of patients. Radiotherapy of the primary lesion alone might be superior to metastatic sites. Further confirmatory studies are needed to confirm our findings."

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

Osimertinib vs. 1st/2nd-Generation EGFR-TKIs as First-Line Therapy for Non-Small Cell Lung Cancer: A Real-World Study in HK (IASLC-WCLC 2026) - "Inverse probability of treatment weighting (IPTW) was applied to balance confounders between Osimertinib users and earlier generation EGFR-TKIs (gefitinib, erlotinib, afatinib) users. Cox regression analysis also revealed that patients treated with Osimertinib had significantly lower mortality risk in both the full cohort and case review subcohort. Conclusions : Osimertinib showed superior clinical benefits as first-line treatment for advanced EGFR-mutated NSCLC compared with earlier generations of EGFR-TKIs regardless of history of brain metastasis status, with longer progression free duration."

Clinical • Real-world • Real-world evidence • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. (PubMed, N Engl J Med) - P3; "Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125.)."

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

RELAY+: Final Overall Survival With Ramucirumab Plus Gefitinib in Patients With Untreated EGFR-Mutated Metastatic NSCLC. (PubMed, JTO Clin Res Rep) - "Patients received RAM (10 mg/kg every 2 wk) plus GEF (250 mg once daily) until disease progression (period 1); patients with disease progression who acquired a T790M mutation received RAM plus osimertinib (80 mg once daily) (period 2). Treatment-emergent T790M rate post progression was 81.3%. RELAY+ revealed a favorable benefit-risk profile for RAM plus GEF in East Asian patients with untreated EGFR-mutated metastatic NSCLC, supporting RAM plus GEF as an alternative first-line treatment option, particularly in those with an L858R mutation."

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

OS Update of the Efficacy and Safety That Radioactive Seed Implantation Combined With EGFR-TKI in the First-Line Treatment of EGFR Mutation NSCLC. (IASLC-WCLC 2026) - "Introduction : Representative EGFR-TKIs, such as gefitinib, afatinib, and osimertinib, have become the first-line standard treatment for patients with classical EGFR mutations (exon 19 deletions and exon 21 L858R) non-small cell lung cancer, with Progression-Free Survival (PFS) ranging from 10 to 20 months. The updated DOR is 21.6 (95% CI,14.5-39.7) months.The safety profile remained consistent, with no additional safety signals observed. Conclusions : EGFR-TKI therapy combined with RSI confers a significant PFS benefit and merits further prospective investigation."

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

Factors Associated With One-Year Survival in EGFR-Mutant Lung Adenocarcinoma on EGFR-TKI (IASLC-WCLC 2026) - "The most frequently used EGFR-TKI was gefitinib (50.0%), followed by erlotinib (31.3%), afatinib (15.6%), and osimertinib (3.1%). Conclusions : One-year overall survival in patients with EGFR-mutant lung adenocarcinoma receiving EGFR-TKI at a tertiary hospital in Indonesia was relatively favorable, with a mean survival of 10.92 months. These findings provide important local data on survival outcomes in patients with EGFR-mutant lung adenocarcinoma treated with EGFR-TKI and may support future larger studies in the Indonesian population."

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