^
    3ms
    Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC (clinicaltrials.gov)
    P3, N=275, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P3 trial • Metastases
    |
    Xalkori (crizotinib) • foritinib (SAF-189)
    4ms
    Population pharmacokinetics and exposure-response analyses of SAF-189s in Chinese patients with ALK+/ROS1+ non-small cell lung cancer. (PubMed, Front Pharmacol)
    The 210-mg dose group had a significantly higher safety risk, while the 160-mg dose group was well-tolerated. Thus, 160 mg of SAF-189s once daily was selected as the recommended phase III dose for the ALK+/ROS1+ or ROS1+ NSCLC patients.
    PK/PD data • Journal
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    foritinib (SAF-189)
    4ms
    Foritinib in advanced ROS1-rearranged non-small-cell lung cancer in China: a multicentre, open-label, single-arm, phase 2 study. (PubMed, Lancet Respir Med)
    Foritinib showed systemic and intracranial antitumour activity and good tolerability in ROS1-inhibitor-naive patients with ROS1-rearranged NSCLC. Foritinib represents a promising treatment for these patients, especially in those with CNS metastases.
    P2 data • Journal • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    foritinib (SAF-189)
    over1year
    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)
    2years
    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)
    over2years
    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)
    over3years
    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)