BEBT-109 / BeBetter Med - LARVOL DELTA

Phase Ib/II trials of BEBT-109 in advanced NSCLC with EGFR exon 20 insertion mutations (ESMO Asia 2025) - P2 | "BEBT-109 demonstrated favorable efficacy and manageable safety in ex20ins-positive NSCLC after platinum-based chemotherapy, with notable PFS improvements, supporting further clinical development."

EGFR exon 20 • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety outcomes of emerging EGFR‑TKIs for patients with non‑small cell lung cancer with EGFR exon 20 insertion mutations: A systematic review and meta‑analysis. (PubMed, Oncol Lett) - "Subgroup analysis revealed the following ORRs: 0.731 (95% CI, 0.560-0.901; I2=0%) for YK-029A; 0.608 (95% CI, 0.511-0.705; I2=0%) for sunvozertinib; 0.602 (95% CI, 0.440-0.764; I2=80.2%) for furmonertinib; 0.602 (95% CI, 0.486-0.718; I2=84.5%) for befotertinib; 0.566 (95% CI, 0.236-0.896; I2=96.3%) for amivantamab; 0.444 (95% CI, 0.215-0.674; I2=0%) for BEBT-109; and 0.256 (95% CI, 0.178-0.334; I2=75.0%) for poziotinib. In conclusion, the emerging EGFR-TKIs for NSCLC with EGFR exon 20 insertion have a promising treatment outcome with a manageable safety profile. However, further analysis is needed when more clinical data are released."

Journal • Retrospective data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: BeBetter Med Inc

EGFR exon 20 • Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: BeBetter Med Inc

EGFR exon 20 • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-in-human phase I study of BEBT-109 in previously treated EGFR exon 20 insertion-mutated advanced non-small cell lung cancer. (PubMed, Med) - "Preliminary findings showed that BEBT-109 had an acceptable safety profile and favorable antitumor activity in patients with refractory EGFR ex20ins-mutated aNSCLC."

EGFR exon 20 • Journal • Metastases • P1 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Antitumor Activity and Safety of BEBT-109, a Novel EGFR Inhibitor, in Previously Treated NSCLC (clinicaltrials.gov) - P1b | N=23 | Completed | Sponsor: Hunan Province Tumor Hospital

EGFR exon 20 • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor