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• W3088075463 abstract "Checkpoint inhibitors (CPI) are standard therapy for pts with mUC following progression on PLT-based chemotherapy with response rates of 13–29% and limited complete responses. SG is a novel antibody-drug conjugate (ADC) comprised of a humanized monoclonal anti–Trop-2 antibody coupled to SN-38 via a unique hydrolyzable linker. Trop-2 is an epithelial cell surface antigen differentially expressed in malignant vs normal tissues, especially in UC. The phase 1/2 IMMU-132-01 trial reported an ORR of 31% with SG alone in pts with mUC, while interim data from the phase 2 TROPHY-U-01 trial cohort 1 (n=35 pts with heavily pretreated mUC who progressed on PLT, CPI) confirmed those results (ORR 29%).SG toxicity was manageable with notable AEs of neutropenia and diarrhea. An ADC with CPI showed high ORR in pts with previously untreated mUC; we hypothesize that SG with CPI may significantly benefit pts with PLT-refractory mUC. TROPHY-U-01 (NCT03547973) is a multi-cohort, open-label, global phase 2 trial. Cohort 3 will enroll up to 61 CPI-naïve pts with progression/recurrence after PLT-based therapy. Key inclusion criteria: ECOG PS 0 or 1, creatinine clearance ≥30 mL/min, adequate organ function. Key exclusion criteria for cohort 3: active autoimmune disease, history of interstitial lung disease. Three SG doses may be tested in combination with Pembro 200 mg in a 10-pt safety cohort lead-in to determine the recommended phase 2 dose (RP2D). A Simon 2-stage design will be conducted after RP2D identification. Stage 1 contains 21 pts (including 10 pts in the safety lead-in treated with RP2D) and up to 41 pts enrolled at the RP2D, if target clinical activity is noted at stage 1. Pts will first receive SG on days 1 and 8 with Pembro 200 mg only on day 1 of a 21-day cycle until unacceptable toxicity or disease progression. Primary objective is ORR by central review using RECIST 1.1. Secondary objectives are safety/tolerability, DOR, CBR, PFS per investigator and central review by RECIST 1.1, and investigator review by iRECIST criteria. Enrollment began in March 2020 and will continue across ∼40 sites in the USA and France. NCT03547973. Immunomedics, Inc. Immunomedics, Inc." @default.
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• W3088075463 date "2020-09-01" @default.
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• W3088075463 title "796TiP TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy" @default.
• W3088075463 doi "https://doi.org/10.1016/j.annonc.2020.08.2067" @default.
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