Tagrisso (osimertinib) / AstraZeneca - LARVOL DELTA

Osimertinib (osi) with or without chemotherapy (CTx) as first-line treatment in EGFR-mutant (EGFRm) advanced NSCLC with concurrent TP53 mutations (TOP study) (ELCC 2026) - P3 | "Patients were randomized 1:1 to receive osi + CTx (osi 80 mg QD + pemetrexed 500 mg/m 2 + carboplatin AUC5, Q3W for 4 cycles, followed by osi 80 mg QD + pemetrexed 500 mg/m 2 Q3W) or osi monotherapy (80 mg QD) until disease progression or intolerable toxicities. Legal entity responsible for the study Sun Yat-sen University Cancer Center. Funding AstraZeneca."

Clinical • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • TP53

Predictors of benefit from local consolidative therapy and patterns of failure for metastatic EGFR-mutant NSCLC: A secondary analysis of NorthStar, a phase II randomized clinical trial (ELCC 2026) - P1 | "Background The NorthStar trial demonstrated improved progression free survival (PFS) with local consolidative therapy (LCT; radiotherapy [RT] or surgery) added to Osimertinib (Osi) in metastatic EGFR-mutant NSCLC (25.4 vs 17.5 months [mo]; HR 0.66, 90% CI 0.50–0.87; p=0.025)...Clinical trial identification NCT04479306. Legal entity responsible for the study The authors."

Clinical • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • EGFR

Becotarug (JMT101) and osimertinib (Osi) in patients (pts) with platinum-pretreated EGFR exon 20 insertion-mutated (ex20ins) non-small cell lung cancer (NSCLC): Final overall survival (OS) and subgroup analyses from the BECOME phase II study (ELCC 2026) - P2 | "Legal entity responsible for the study Shanghai JMT-Bio Technology Co., Ltd. Funding Shanghai JMT-Bio Technology Co., Ltd."

Clinical • EGFR exon 20 • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Tiragolumab Plus Atezolizumab and Bevacizumab in Targeted Therapy-Refractory, Immune Checkpoint Blockade-Naive, Advanced EGFR-Mutated NSCLC (IASLC-TTLC 2026) - P2 | "One patient was started on osimertinib monotherapy following disease progression on docetaxel plus ramucirumab after progression on trial therapy and developed hepatic failure resulting in death (grade 5). Accrual was halted early following termination of tiragolumab development. Interim analysis demonstrated minimal clinical efficacy of dual ICB with VEGF inhibition in TT- refractory, ICB-naïve EGFRm NSCLC. These findings suggest this combination is unlikely to represent an effective therapeutic strategy in this population."

Checkpoint block • Checkpoint inhibition • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • TIGIT

Molecularly-informed prediction of treatment efficacy in the GENIE BPC NSCLC cohort using computational reasoning (AACR 2026) - "Here, we extend this analysis to the GENIE BPC NSCLC cohort to assess the broader clinical validity of DDA. From the GENIE BPC NSCLC cohort data available on Synapse, we included 1,078 patients with a single-sample genomic profile, available primary treatment data and survival outcomes (total 2,103 treatment lines, therapies included: afatinib, erlotinib, osimertinib, crizotinib, nivolumab, pembrolizumab, atezolizumab, bevacizumab+chemo, ramucirumab+chemo; and chemotherapy alone). Across a large, real-world NSCLC cohort, DDA effectively distinguished therapies with higher clinical efficacy based on the full molecular profile of each patient. These results reinforce the potential of DDA to enhance personalized treatment selection based on NGS diagnostics in precision oncology."

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

TAS3351 is a brain penetrable EGFR-TKI that overcomes T790M and C797S resistant mutations. (PubMed, Commun Med (Lond)) - "These findings indicate that TAS3351 is a promising therapeutic candidate for patients with NSCLC whose tumors have relapsed or are refractory to treatment due to the C797S and T790M mutations, and the brain metastases."

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

BECOME Study at ELCC 2026: Becotarug Plus Osimertinib Shows Survival Benefit in EGFR Exon 20 Insertion NSCLC (OncoDaily) - "The combination of becotarug and osimertinib demonstrated encouraging survival outcomes in this heavily pretreated population...Median overall survival reached 18.0 months, suggesting clinically meaningful benefit in a setting where treatment options are limited...Notably, patients with far-loop insertions demonstrated significantly improved overall survival compared with those with near-loop insertions, with a hazard ratio of 0.58 and a statistically significant difference. Median overall survival in this subgroup reached 25.6 months, compared with 15.6 months in patients with near-loop insertions....Median progression-free survival reached 14.5 months in ctDNA-negative patients, compared with 6.9 months in ctDNA-positive patients."

EGFR exon 20 • P2 data • Non Small Cell Lung Cancer

Profiling membrane antigen expression of select antibody-drug conjugate (ADC) targets in EGFR-altered non-small cell lung cancer treated with osimertinib (AACR 2026) - "In patients with EGFR-altered NSCLC, we identified high expression of ERBB2, MET, and TACSTD2 (TROP2) in both pre- and post-treated samples. This may provide rationale for use of these ADC targets in second-line therapy, such as seen in recent approvals for trastuzumab deruxtecan in ERBB2-mutated, telisotuzumab vedotin in c-MET over-expressing, and datopotamab deruxtecan in EGFR-altered NSCLC. Notably, high MET pre-treatment expression was associated with poor survival outcome and appeared to be associated with post-osimertinib resistance."

ADC • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3 • HER-2 • MET • NECTIN4 • TACSTD2

Identification of DXd sensitivity biomarkers and osimertinib induced datopotamab deruxtecan (Dato-DXd) internalization as potential mechanisms for enhanced activity of Dato-DXd in preclinical models of EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC) (ELCC 2026) - "Importantly, data also indicated the potential of osimertinib pre-treatment to enhance TROP2 expression and Dato-DXd internalization in EGFRm models.Conclusions These preclinical data support the notable clinical activity of Dato-DXd in EGFRm NSCLC and provide a potential mechanistic rationale for why EGFRm disease has broad inherent sensitivity to Dato-DXd. Further validation in clinical cohorts is warranted."

Preclinical • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ABCC1 • EGFR • TACSTD2

TROP2 normalised membrane ratio (NMR) assessed by quantitative continuous scoring (QCS): Association with clinical outcomes with datopotamab deruxtecan (Dato-DXd) ± osimertinib (osi) in EGFR-mutated (EGFRm) NSCLC (ELCC 2026) - P1, P2, P3 | "Data indicate that pts with EGFRm NSCLC derive benefit from Dato-DXd irrespective of TROP2 NMR status, suggesting limited value in pt selection for Dato-DXd therapy in this setting. Benefit of Dato-DXd in pts with EGFRm NSCLC is being tested in phase III studies (1st-line osi + Dato-DXd, TROPION-Lung14, NCT06350097; 2nd-line Dato-DXd ± osi, TROPION-Lung15; NCT06417814)."

Clinical • Clinical data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR-mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC). (ASCO 2025) - P3 | "Overall survival is a key secondary endpoint; other secondary endpoints include PFS by investigator, objective response rate, duration of response, PFS2, safety, pharmacokinetics and immunogenicity. Enrollment is ongoing."

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

Osimertinib (osi) + datopotamab deruxtecan (Dato-DXd) in patients (pts) with EGFR-mutated (EGFRm) advanced NSCLC (aNSCLC) whose disease progressed on first-line (1L) osi: ORCHARD (ELCC 2025) - P2 | "Osi + Dato-DXd showed promising efficacy and manageable safety in pts with EGFRm aNSCLC who progressed on 1L osi. There were no new safety signals. Considering the overall benefit/risk profile, 6 mg/kg should be the preferred Dato-DXd starting dose for combination with 80 mg osi."

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

Case Report: Rare Multidrug-Resistant Enterobacter Cloacae Complicated by Invasive Pulmonary Aspergillosis in an Elderly Patient with Advanced Lung Adenocarcinoma Treated with Osimertinib. (PubMed, Infect Drug Resist) - "We report a rare case of multidrug-resistant (MDR) Enterobacter cloacae pneumonia complicated by invasive pulmonary aspergillosis (IPA) in a 75-year-old male with lung adenocarcinoma who had been receiving osimertinib for 8 months. Prompt susceptibility-guided therapy with polymyxin B plus tigecycline (for MDR bacteria) and voriconazole (for aspergillosis) achieved complete resolution, highlighting the importance of rapid microbiological diagnosis and targeted antimicrobials in this vulnerable population."

Journal • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. (PubMed, N Engl J Med) - P3 | "Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.)."

Journal • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • EGFR

Efficacy of EGFR tyrosine kinase inhibitors in patients with non-small cell lung cancer with EGFR exon 19 insertions: clinical-genomic, preclinical analysis through LC-SCRUM-Asia (multi-institutional genomic screening registry). (PubMed, Lung Cancer) - "Our preclinical, structural, and clinical findings indicate 2nd-generation EGFR-TKIs are more effective for EGFRex19ins compared to other TKIs."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. (PubMed, Nat Med) - P3 | "MRD detection could potentially identify patients who may benefit from longer adjuvant osimertinib, although this requires clinical confirmation. ClinicalTrials.gov identifier: NCT02511106 ."

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

Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small-Cell Lung Cancer. (PubMed, J Clin Oncol) - "Neoadjuvant osimertinib with or without chemotherapy demonstrated statistically significant improvement in the MPR rate over chemotherapy alone in patients with resectable, EGFR-mutated, stage II-IIIB NSCLC."

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

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

Ultrasensitive MRD Improves Detection in Resectable Stage I NSCLC (IASLC-WCLC 2025) - P | "Both preoperative ctDNA and postoperative MRD were associated with a trend to shortened RFS, even though a significant fraction of MRD positive patients later received adjuvant chemotherapy or osimertinib (ongoing)...MRD detection was associated with RFS and provided clinically relevant lead times. These results support exploring ultrasensitive ctDNA MRD-guided treatment strategies in stage I NSCLC."

Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLC (IASLC-WCLC 2025) - P2 | "MET ctDNA NGS had high specificity but modest sensitivity for MET FISH10+ detection, with further reduced sensitivity when IHC90+ was also considered. Acquired resistance mutation profiles to savolitinib ± osimertinib included known on-target and suspected bypass signalling resistance mechanisms."

Biomarker • Clinical • Discordant • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • BRAF • EGFR • ERBB3 • MET

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

NorthStar: A phase II randomized study of osimertinib (OSI) with or without local consolidative therapy (LCT) for metastatic EGFR-mutant non-small cell lung cancer (NSCLC) (ESMO 2025) - P1 | "Conclusions The addition of local consolidative therapy to osimertinib significantly extends progression-free survival in patients with EGFR-mutant metastatic NSCLC, even in the setting of polymetastatic disease. These results support the integration of LCT into the treatment paradigm for appropriately selected patients receiving EGFR-targeted therapy and may inform future standards of care."

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

FLAURA2: Exploratory overall survival (OS) analysis in patients (pts) with poorer prognostic factors treated with osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) as first-line (1L) treatment (tx) for EGFR-mutated (EGFRm) advanced NSCLC (ESMO 2025) - P3 | "Conclusions A survival benefit favouring osi + CTx vs osi mono was consistently observed across each prognostic subgroup evaluated, reinforcing osi + CTx as a 1L standard of care in this setting. Table: LBA77 Osi + CTx Osi mono HR (95% CI) Events/pts, n mOS, mo (95% CI) Events/pts, n mOS, mo (95% CI) Baseline CNS mets Yes 71/116 40.9 (35.2, 46.6) 79/110 29.7 (25.6, 35.8) 0.72 (0.52, 0.99) No 73/163 NR (45.0, NC) 92/168 43.9 (37.8, 53.3) 0.77 (0.57, 1.05) EGFRm L858R 66/106 38.1 (33.4, 42.0) 74/107 32.4 (28.0, 37.6) 0.76 (0.55, 1.07) Ex19del 78/172 NR (47.2, NC) 95/169 43.0 (35.7, 51.9) 0.76 (0.56, 1.02) Plasma EGFRm Det 88/148 38.4 (33.2, 46.6) 114/161 32.5 (28.8, 35.8) 0.79 (0.60, 1.03) Undet 24/65 NR (50.8, NC) 21/48 NR (46.0, NC) 0.79 (0.44, 1.44) Tissue TP53 Altered 22/46 51.1 (35.0, NC) 25/40 43.1 (34.0, 50.1) 0.71 (0.40, 1.27) Wild type 11/33 NR (46.6, NC) 14/34 NR (41.3, NC) 0.70 (0.32, 1.54) NC, not calculable"

Biomarker • Clinical • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR • TP53

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

Osimertinib after definitive chemoradiotherapy in patients with unresectable stage III EGFR-mutated NSCLC: LAURA China cohort. (PubMed, Lung Cancer) - "Osimertinib after definitive CRT demonstrated PFS benefit over placebo and a manageable safety profile in the China cohort, consistent with findings in the global LAURA population. The results support the use of osimertinib after definitive CRT as the new standard of care, globally and in China, for patients with unresectable stage III EGFR-mutated NSCLC."

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