Gilotrif (afatinib) / Boehringer Ingelheim - LARVOL DELTA

Haematological toxicities with targeted drugs in tumors: A systematic review and network meta-analysis of randomized controlled trials (ASH 2025) - "1 patient treated with sorafenib plus chemotherapy was reported to have died as a result of pancytopenia and 1 patient treated with chemotherapy (gemcitabine plus cisplatin) died due to anemia. Our study confirmed that chemotherapy with or without a placebo, one targeted drug with chemotherapy was associated with more severe hematologic toxicities compared with the use of one targeted drug, tepotinib plus gefitinib, tivantinib plus erlotinib. In the targeted drug monotherapy category, for the primary outcome, we found that alectinib and gefitinib had a higher risk of all-grade (grade 1-5) and severe-grade (grade 3-5) anemia, respectively...Ganitumab plus chemotherapy had the highest risk of grade 1-5 anemia and thrombocytopenia. Afatinib plus chemotherapy had the highest risk of grade 3-5 anemia and thrombocytopenia. Ramucirumab plus chemotherapy had the highest risk of grade 1-5 and 3-5 neutropenia. Veliparib plus chemotherapy had the highest risk of grade 1-5 and 3-5..."

Retrospective data • Review • Febrile Neutropenia • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia

Afatinib boosts CAR-T cell antitumor therapeutic efficacy via metabolism and fate reprogramming (ASH 2025) - "Based on it, we finallyidentified the antitumor efficacy of AFA-pretreatment CAR-T compared with negative-control CAR-T. We identified that AFA blocked the T-cell receptor (TCR) and phosphoinositide 3-kinase-proteinkinase B-mechanistic target of rapamycin signaling pathways, induced metabolic reprogramming andmodulated T-cell differentiation. Our study systematically demonstrated that AFA pretreatment effectively enhanced CAR-Tcells antitumor performance, which presents a novel optimization strategy for potent and durable CAR-Tcell therapy."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Leukemia • Oncology • SELL

EGFR exon 19 duplications/insertions, rare but potential therapeutic targets for NSCLC: A real-world study and pooled analysis of case series (ESMO Asia 2025) - "Stratified by treatment, mPFS1 was 15.5 months with erlotinib (IQR: 9.4-20.0), 12.3 months with afatinib (IQR 7.8-14.3), 7.8 months with osimertinib (IQR 5.6-9.4), 10.9 months with icotinib (IQR 5.9-12.6), 5.3 months with gefitinib (IQR 4.7-9.2), and 6.0 months with immuno/chemotherapy (IQR 3.9-9.0). E19dup/ins are exceedingly rare EGFR genomic alterations with 4 variants reported to date. There is a potential PFS benefit with the use of erlotinib over immuno/chemotherapy as first-line treatment for these mutations. Further data are required to confirm the role of erlotinib in this setting."

Real-world • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

An observational study of afatinib 30mg daily in patients with advanced non-small cell lung cancer (NSCLC) harbouring common EGFR mutations (ESMO Asia 2025) - P | "First line afatinib at 30mg once daily was well-tolerated. Despite early termination of the study, afatinib 30mg daily had a similar efficacy to standard dose afatinib with a 6-month PFS rate of 93.2%."

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

Analysis of the efficacy and safety of radioactive seed Implantation combined with EGFR-TKI in the first-line treatment of classical EGFR mutation NSCLC (ESMO Asia 2025) - "Background: 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 PFS ranging from 10 to 20 months...PFS has not yet reached for those receiving 2nd agents (only two patients, both treated with dacomitinib, still in follow-up currently), and 39.9m for those receiving 3rd agents. EGFR-TKI therapy combined with RSI confers a significant PFS benefit and merits further prospective investigation."

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

Cancer therapy-related cardiac dysfunction associated with EGFR-TKIs in advanced EGFR-mutant non-small cell lung cancer: A single-center prospective observational study (ESMO Asia 2025) - "Global longitudinal strain (GLS), tricuspid regurgitation peak gradient (TRPG), E/e′ ratio, Troponin-T and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP), were also analyzed using generalized estimating equations. Among 100 patients included in this study (median age 64; 39.0% male, 61.0% female; 72.0% non-smokers), 66.0% patients received osimertinib, 16.0% received erlotinib, 13.0% received afatinib, and 5.0% received dacomitinib. Our study demonstrates the incidence of CTRCD in patients with advanced or recurrent EGFR-mutant NSCLC receiving EGFR-TKI treatment, and compares the effect between osimertinib and first or second generation TKIs. Increased E/e′ ratio was found in osimertinib group, indicating increased diastolic dysfunction. These findings highlight the importance of clinical monitoring of cardiac function in patients receiving TKIs, particularly in those treated with osimertinib."

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

Drug utilisation evaluation of oral anticancer therapy in a south indian cancer centre (ESMO Asia 2025) - "Among targeted therapies, Gefitinib, Osimertinib, Crizotinib, Afatinib, Lorlatinib, and Nilotinib demonstrated consumption of 30 DDDs per patient over 30 days. Lower consumptions were observed with Lenvatinib and Cabozantinib with 13.3 DDDs and 11.25 DDDs per patient respectively. In the hormonal therapy group, Letrozole, Tamoxifen, Bicalutamide, Anastrozole, Enzalutamide, and Exemestane were all prescribed in line with WHO standards (30 DDDs per patient), whereas Abiraterone exhibited lower consumption of 15 DDDs per patient. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Dose deviations occurred, though reasons were unclear and may relate to adverse effects, indication-specific or patient factors, or economic constraints. Further research is warranted..."

Oncology • Oral Cancer

Two Cases of Epidermal Growth Factor Receptor L861R Mutation-Positive Lung Adenocarcinoma Treated With Osimertinib and Afatinib. (PubMed, Cancer Rep (Hoboken)) - "Here, we present the first case showing the anti-tumor efficacy of afatinib and the second case showing the anti-tumor efficacy of osimertinib in a patient with EGFR L861R-positive lung adenocarcinoma. Despite their short treatment durations, afatinib and osimertinib may have potential clinical activity in patients with EGFR L861R-positive lung cancer."

Journal • Dermatology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • EGFR

Survival benefit of targeted therapy in EGFR-mutant NSCLC patients with leptomeningeal metastases (SNO 2025) - "The interventions included Afatinib, Erlotinib, Furmonertinib, Gefitinib, Osimertinib, and Rociletinib. This meta-analysis provides the first pooled survival estimate in EGFR-mutant NSCLC patients with LMD receiving targeted therapies. The findings suggest that modern EGFR TKIs may offer clinically meaningful survival benefits in this otherwise high-risk group. Prospective studies are needed to validate these results and to define optimal treatment strategies."

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

An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Precision Biotech Taiwan Corp.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Construction of a survival prognosis model for epithelial-mesenchymal transition-related genes in gastric cancer. (PubMed, Eur J Med Res) - "Our study provides a prognostic assessment tool for GC based on EMT-related genes and offers novel insights into understanding the roles of EMT in GC progression and treatment resistance. These findings may aid in the development of precision therapy strategies for GC."

Journal • Gastric Cancer • Oncology • Solid Tumor • NPR3 • OLFML2B

A targeted combination therapy achieves effective pancreatic cancer regression and prevents tumor resistance. (PubMed, Proc Natl Acad Sci U S A) - "Likewise, a combination of selective inhibitors of KRAS (RMC-6236/daraxonrasib), EGFR family (afatinib), and STAT3 (SD36) induced the complete regression of orthotopic PDAC tumors with no evidence of tumor resistance for over 200 d posttreatment...Of importance, this combination therapy was well tolerated. In sum, these results should guide the development of new clinical trials that may benefit PDAC patients."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • EGFR • KRAS • TP53

Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: Taichung Veterans General Hospital

New trial • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Inhibition of CDKs Enhances Efficacy of Anti-EGFR Therapy in Chordoma. (PubMed, Mol Cancer Ther) - "Importantly, co-treatments exhibited greater inhibition of tumor growth than single treatments in cell line- and patient-derived xenograft models. Taken together, our data revealed that THZ1 or TG02 enhanced in vitro and in vivo efficacy of afatinib, suggesting a potential novel combination therapeutic strategy for patients with chordoma."

Journal • Chordoma • Oncology • MCL1

A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2028 ➔ Sep 2028 | Initiation date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Apr 2027 ➔ Sep 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Reply to the Letter by Kataoka et al.: Evidence Supporting a Ventricular Origin in Afatinib-associated Arrhythmia. (PubMed, Intern Med) - No abstract available

Journal • Cardiovascular

Afatinib-associated pseudo-acute kidney injury. (PubMed, Clin Kidney J) - No abstract available

Journal • Acute Kidney Injury • Nephrology • Renal Disease

Computational profiling of flavonoids against key breast cancer targets: an in-silico exploration. (PubMed, In Silico Pharmacol) - "Comparative docking with five reference drugs (Alpelisib, Buparlisib, Lapatinib, Gefitinib, and Afatinib) identified nine flavonoids; Sphaerobioside, Avicularin, Nicotiflorin, Myricetin, Quercitrin, Rutin, Isoquercetin, Didymin, and Robinin as promising candidates with favorable binding affinities and stable receptor interactions...Collectively, these findings highlight the multitarget inhibitory potential of selected flavonoids and demonstrate how integrated computational profiling can accelerate the discovery and optimization of natural product-based anticancer agents. The online version contains supplementary material available at 10.1007/s40203-025-00489-0."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • EGFR • HER-2

Neoadjuvant Radiotherapy Plus Targeted Therapy and Immunotherapy vs. Targeted Therapy Plus Immunotherapy in Resectable HNSCC (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: West China Hospital | N=98 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pharmacogenomic Drug-Target Network Analysis Reveals Similarity Profiles Among FDA-Approved Cancer Drugs. (PubMed, Pharmaceutics) - "Well-established drug pairs, such as cytarabine-gemcitabine or afatinib-neratinib, exhibited high B-index and structural similarity values, validating the methodology. Additionally, the B-index provides an alternative to conventional chemical similarity metrics, which can facilitate the identification of new therapeutic relationships and inform new drug applications and repositioning. These findings pave the way for the proposal of novel oncology drug targets."

Biomarker • FDA event • Journal • Oncology

Novel FAK inhibitors suppress tumor growth and reverse EGFR-TKI resistance in non-small cell lung cancer. (PubMed, Cancer Drug Resist) - "Notably, these compounds were shown to resensitize resistant NSCLC cells to EGFR-TKIs, with 10k inhibiting tumor growth and enhancing Osimertinib efficacy in resistant xenografts. These findings not only uncover a pivotal mechanism of EGFR-TKI drug resistance but also highlight innovative, promising therapeutic options for patients with therapy-refractory disease."

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

Exon Mutations and D-Dimer Levels in EGFR-Mutant Lung Adenocarcinoma: Correlation With 1-Year Progression-Free Survival at Ahmad Yani Metro General Hospital, Indonesia (APSR 2025) - "One person was given oral TKI osimertinib, 16 people were given afatinib and 1 person was given erlotinib with median progression free survival (PFS) value of 25 months (osimertinib) versus 12.37 months (afatinib) versus 4 months (erlotinib). Conclusion : Osimertinib shows superior progression free survival (PFS) compared to other TKIs, and its early use in EGFR mutant adenocarcinoma may improve outcomes. Elevated D-dimer levels indicate shorter life expectancy, as they reflect increased coagulation and inflammation, leading to more complications and poorer prognosis.3."

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

Afatinib for a non-small cell lung cancer patient in hemodialysis: A case report and literature review. (PubMed, Cancer Chemother Pharmacol) - "Notably, no adverse events were observed, and the patient has maintained a partial response for over eight months. This case suggests that afatinib can be administered without major dose modification in HD patients, with PK data indicating minimal impact of dialysis and underscoring the importance of accumulating real-world evidence in this underrepresented population."

Journal • Review • Chronic Kidney Disease • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • EGFR

Novel Resistance Mechanisms to Second-Generation EGFR Tyrosine Kinase Inhibitor Afatinib and Associations With Genomic Features in NSCLC. (PubMed, Genes Chromosomes Cancer) - "The study identified multiple genomic characteristics associated with primary and secondary resistance to first-line afatinib treatment in EGFR- and ERBB2-positive subpopulations."

Journal • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDKN2A • EGFR • HER-2 • MET • NF1 • TMB

Tumor heterogeneity involving SCLC with a single exon deletion in RB1 and adenocarcinoma with EGFR-L718V mutation in EGFR-TKI-resistant lung cancer. (PubMed, Lung Cancer) - "Spatially distinct and simultaneous resistance mechanisms, namely, EGFR L718V mutation and SCLC transformation, contributed to osimertinib resistance. The detection of RB1 2.4 kb small deletion in RB1 gene highlights the importance of deep genomic profiling. Multi-site biopsy and molecular diagnostics are necessary to guide treatment decisions in EGFR-TKI-resistant NSCLC."

Heterogeneity • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • RB1 • TP53