Geller JI, Pressey JG, Smith MA, Kudgus RA, Cajaiba M, Reid JM, Hall D, Barkauskas DA, Voss SD, Cho SY, Berg SL, Dome JS, Fox E, Weigel BJ. ADVL1522: A phase 2 study of lorvotuzumab mertansine (IMGN901) in children with relapsed or refractory wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor, or synovial sarcoma-A Children’s Oncology Group study. Cancer. 2020 Dec 15;126(24):5303-5310. doi: 10.1002/cncr.33195. Epub 2020 Sep 11. PubMed PMID: 32914879; PubMed Central PMCID: PMC7732143.
Study ID Citation
Abstract
Lorvotuzumab mertansine (IMGN901; LM) is an antibody-drug conjugate, linking an anti-mitotic agent (DM1) to an anti-CD56 antibody (lorvotuzumab). Preclinical efficacy is noted in Wilms tumor (WT), rhabdomyosarcoma (RMS), and neuroblastoma (NBL). Synovial sarcoma (SS), MPNST and pleuropulmonary blastoma (PPB) also express CD56. A phase 2 trial of LM was conducted to assess efficacy, the RP2D and toxicities. Eligible patients had relapsed after or progressed on standard therapy for their tumor type. LM (110 mg/m2/dose) was administered at the adult recommended phase 2 dose (RP2D) intravenously on days (d) 1 and 8 of 21 d cycles. Dexamethasone pre-medication was used. Pharmacokinetics (PK) samples, peripheral blood CD56-positive cell counts, and tumor CD56 expression were assessed.