Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (2025)
12 slides from Bayer's technical presentation, 2025
Slide 1: Updated Efficacy, Safety, and Genomic Data in Patients with TRK Fusion Lung Cancer Treated with Larotrectinib
UPDATED EFFICACY, SAFETY, AND GENOMIC DATA IN PATIENTS WITH TRK FUSION LUNG CANCER TREATED WITH LAROTRECTINIB Jessica J. Lin,1 Victor Moreno,2 Shivaani Kummar,3 Daniel S.W. Tan,4 Damian T. Rieke,5 Biswajit Dubashi,6 Kunhi Parambath Haresh,7 Domnita-Ileana Burcoveanu,8 Natascha Neu,9 Hong Zheng,10 Ku
Slide 2: Introduction and study design
Introduction and study design • NTRK gene fusions are oncogenic drivers in a variety of cancers, including lung Adult phase 1 Endpoints cancer.1 (NCT02122913) • Age ≥18 years n=1 Primary • ORR per IRC • Advanced solid tumors assessment • Larotrectinib is the first-in-class, highly 32 patients (RECIS
Slide 3: Baseline Characteristics in Patients with TRK Fusion Lung Cancer
Baseline Characteristics in Patients with TRK Fusion Lung Cancer N=32 N=32 Age, years, median (range) 55.5 (25–81) Prior therapies, n (%)§ Surgery 16 (50) Sex, n (%) Radiotherapy 15 (47) Female 19 (59) Systemic therapy in the metastatic/unresectable setting 31 (97) Male 13 (41) Immunotherapy 13 (41)
Slide 4: Efficacy: ORR, DoR, PFS, and OS
Efficacy: ORR, DoR, PFS, and OS • ORR was 69% (95% CI 50–84). DoR Total (N=22) PFS Total (N=32) Median DoR, months (95% CI) 34 (13–NE) Median PFS, months (95% CI) 22 (10–39) • The median time to response was 1.8 months 100 Median follow-up, months 37 100 Median follow-up, months 38 (range 1.5–7.3).
Slide 5: Biomarker analysis and treatment duration
Biomarker analysis and treatment duration Biomarkers† Baseline Post-baseline ctDNA Confirmed NTRK1 Overall treatment duration (months)†† fusion NTRK3 CTNNB1‡ Tissue Baseline NTRK1 NTRK2 NTRK3 NTRK1 NTRK2 NTRK3 sample GNAS GNAS NRAS NRAS KRAS TP53 TP53 CBL‡ ctDNA ctDNA NTRK gene fusion fusion Both ti
Slide 6: Biomarker analysis and treatment duration
Biomarker analysis and treatment duration Biomarkers† Baseline Post-baseline ctDNA Confirmed NTRK1 Overall treatment duration (months)†† fusion NTRK3 CTNNB1‡ Tissue Baseline NTRK1 NTRK2 NTRK3 NTRK1 NTRK2 NTRK3 sample GNAS GNAS NRAS NRAS KRAS TP53 TP53 CBL‡ ctDNA ctDNA NTRK gene fusion fusion Both ti
Slide 7: Biomarker analysis and treatment duration
Biomarker analysis and treatment duration Biomarkers† Baseline Post-baseline ctDNA Confirmed NTRK1 Overall treatment duration (months)†† fusion NTRK3 CTNNB1‡ Tissue Baseline NTRK1 NTRK2 NTRK3 NTRK1 NTRK2 NTRK3 sample GNAS GNAS NRAS NRAS KRAS TP53 TP53 CBL‡ ctDNA ctDNA NTRK gene fusion fusion Both ti
Slide 8: Biomarker analysis and treatment duration
Biomarker analysis and treatment duration Biomarkers† Baseline Post-baseline ctDNA Confirmed NTRK1 Overall treatment duration (months)†† fusion NTRK3 CTNNB1‡ Tissue Baseline NTRK1 NTRK2 NTRK3 NTRK1 NTRK2 NTRK3 sample GNAS GNAS NRAS NRAS KRAS TP53 TP53 CBL‡ ctDNA ctDNA NTRK gene fusion fusion Both ti
Slide 9: AEs in ≥20% of patients (N=32)
AEs in ≥20% of patients (N=32) All AEs TRAEs (AEs related to larotrectinib) Total 100.0 62.5 31.3 93.8 SAE Dose modifications 50.0 50.0 31.3 12.5 9.4 18.8 • TRAEs were predominantly Discontinuation Myalgia 43.8 3.1 3.1 3.1 3.1 28.1 Grade 1/2. ALT increased 40.6 6.3 6.3 40.6 AST increased Constipatio
Slide 10: Conclusions
Conclusions • Larotrectinib continues to demonstrate rapid and durable responses, extended survival benefit, and a favorable safety profile in patients with advanced TRK fusion lung cancer. • These results support the wider adoption of NGS panels that incorporate NTRK gene fusion detection to detect
Slide 11: Acknowledgments
Acknowledgments • We thank all investigators involved in these studies. • We thank the patients and their families, many of whom travelled long distances to participate in these studies. • Medical writing assistance was provided by Charlotte Simpson, PhD and editorial assistance was provided by Meli
Slide 12: Lung and other thoracic cancers worldwide in the 21st century
RING LUNG AND OTHER THORACIC CANCERS WORLDWIDE IN THE 21ST CENTURY