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    DRUG:

    torvutatug samrotecan (AZD5335)

    i
    Other names: AZD5335, AZD-5335, AZD 5335
    Company:
    AstraZeneca
    Drug class:
    Topoisomerase I inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    2ms
    TREVI-OC-01: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P3, N=1100, Not yet recruiting, AstraZeneca
    New P3 trial • Platinum resistant
    |
    paclitaxel • pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • topotecan • torvutatug samrotecan (AZD5335)
    2ms
    Derivation of AZD5335, a novel FRα-targeted TOP1i-loaded ADC, for the treatment of FRα-expressing cancers. (PubMed, Clin Cancer Res)
    AZD5335 is a promising next-generation ADC capable of targeting ovarian cancers with both high and low FRα expression. AZD5335 demonstrates efficacy in overcoming Elahere-resistance and supports combined treatment strategies.
    Journal • PARP Biomarker
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Elahere (mirvetuximab soravtansine-gynx) • torvutatug samrotecan (AZD5335)
    1year
    FONTANA: Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=396, Recruiting, AstraZeneca | N=150 --> 396
    Enrollment change
    |
    Avastin (bevacizumab) • carboplatin • saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    over2years
    FONTANA: A phase I/IIa study of AZD5335 as monotherapy and in combination with anti-cancer agents in patients with solid tumours (ESMO 2023)
    The study will evaluate AZD5335 as monotherapy in patients with ovarian cancer or lung adenocarcinoma (Module 1), or AZD5335 in combination with AZD5305, a selective poly(ADP-ribose) polymerase 1 inhibitor, in patients with ovarian cancer (Module 2). Secondary objectives include assessment of objective response rate, duration of response, disease control rate, and progression-free survival by RECIST v1.1, and overall survival; characterising the pharmacokinetics of AZD5335 when given as monotherapy or in combination; and assessing immunogenicity. The study will be open to recruitment by 25 May 2023.
    Clinical • P1/2 data • Combination therapy
    |
    FOLR1 ( Folate receptor alpha )
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    over2years
    FONTANA: Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    over2years
    FONTANA: Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, AstraZeneca
    New P1/2 trial • Combination therapy
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    saruparib (AZD5305) • torvutatug samrotecan (AZD5335)
    over2years
    First disclosure of AZD5335, a TOP1i-ADC targeting low and high FRα-expressing ovarian cancer with superior preclinical activity vs FRα-MTI ADC (AACR 2023)
    Furthermore, AZD5335 demonstrated superior activity vs an FRα-MTI benchmark ADC with respect to anti-tumor activity and duration of response in two PDX models with low-to-medium FRα expression at equal or higher drug doses (e.g., in OV0857-CIS: 96% TGI vs 24% TGI at 5 mg/kg and 95% TGI vs 2% TGI at 2.5 mg/kg of a single IV dose AZD5335 and FRα-MTI, respectively). These data indicate that AZD5335 is a promising therapeutic candidate for the treatment of ovarian cancers across the spectrum of FRα-expression.
    Preclinical • Late-breaking abstract
    |
    FOLR1 ( Folate receptor alpha ) • GPI (Glucose-6-Phosphate Isomerase)
    |
    FOLR1 expression
    |
    torvutatug samrotecan (AZD5335)