^
    9ms
    ctDNA analysis of SAF-189s efficacy in ALK+ advanced non-small cell lung cancer (NSCLC) (ESMO 2023)
    Gene co-occurrence survival analysis showed that mPFS of pts harboring FAT3/FAT4 mutations were significantly shorter than those without FAT3/FAT4 mutations (8.9 mo vs 16.5 mo, p=0.012). Conclusions Clinical utility of ctDNA was demonstrated, not only at baseline by identifying fusion types and subgroups of ALK+ NSCLC pts that may benefit more from SAF-189s, but also at progression by tracking ALK-resistant mutations.
    Clinical • Circulating tumor DNA • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • EML4 (EMAP Like 4) • FAT3 (FAT Atypical Cadherin 3) • FAT4 (FAT Atypical Cadherin 4)
    |
    TP53 mutation • ALK positive • ALK rearrangement • ALK fusion • ALK mutation • ROS1 fusion • ROS1 positive • ALK G1202R • EML4-ALK G1202R • FAT4 mutation • ALK-ROS1 fusion • FAT3 mutation
    |
    VENTANA ALK (D5F3) CDx Assay
    |
    foritinib (SAF-189)
    over1year
    A phase II study of SAF-189s in patients with advanced ROS1 fusion-positive non-small cell lung cancer (ESMO Asia 2022)
    Conclusions These findings demonstrate the promising clinical activity and a tolerable toxicity profile of SAF-189s in pts with advanced ROS1+ NSCLC, with or without crizotinib treatment. Clinical trial identification NCT04237805.
    Clinical • P2 data
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ROS1 fusion • ROS1 positive
    |
    Xalkori (crizotinib) • foritinib (SAF-189)
    almost2years
    SAF-189s in advanced, ALK-positive, non–small cell lung cancer: Results from a first-in-human phase 1/2, multicenter study. (ASCO 2022)
    SAF-189s showed clinical antitumor activity and was well tolerated in patients with advanced, ALK+ NSCLC, including those with brain metastases and pretreated with crizotinib. SAF-189s represents a promising, next-generation, targeted therapy for patients with ALK+ NSCLC.
    Clinical • P1/2 data
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive
    |
    Xalkori (crizotinib) • foritinib (SAF-189)
    almost3years
    A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Shanghai Fosun Pharmaceutical Development Co, Ltd. | Trial completion date: Jun 2023 --> Mar 2026 | Trial primary completion date: Jun 2022 --> Dec 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ROS1 positive
    |
    foritinib (SAF-189)