^
    1m
    A Multicenter, Open-label, Randomized Phase III Clinical Trial: Evaluating the Efficacy and Safety of SAF-189s Assisted Therapy Compared to Platinum-based Chemotherapy in Fully Resected Patients with Stage II to IIIB ALK-positive or ROS1-positive NSCLC (ChiCTR2500109405)
    P3, N=210, Not yet recruiting, Shanghai Oriental Hospital; Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
    New P3 trial
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ROS1 positive
    |
    VENTANA ALK (D5F3) CDx Assay
    |
    cisplatin • pemetrexed • foritinib (SAF-189)
    4ms
    Pharmacokinetics, mass balance, and metabolism of [14C]SAF-189s, a potent anaplastic lymphoma kinase/c-ROS proto-oncogene 1 inhibitor in humans: Metabolism potentially affected by interaction of cytochrome P450 enzymes and intestinal microbiota. (PubMed, Drug Metab Dispos)
    The results demonstrated that SAF-189s and its metabolites were primarily excreted via feces, with metabolism likely mediated by both the cytochrome P450 system and gut microbiota. These findings provide essential pharmacokinetic and safety data, encourage further studies on drug interactions and dose adjustments, and support the involvement of gut microbiota, thereby guiding future research.
    PK/PD data • Journal
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    foritinib (SAF-189)
    10ms
    A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer (clinicaltrials.gov)
    P1, N=260, Recruiting, Wuhan Union Hospital, China | Active, not recruiting --> Recruiting | N=49 --> 260 | Trial completion date: Jul 2025 --> Jul 2026
    Enrollment open • Enrollment change • Trial completion date
    |
    Avastin (bevacizumab) • foritinib (SAF-189)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over2years
    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)
    3years
    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)
    over3years
    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)
    over4years
    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)