LY3076226 / Eli Lilly, AbbVie - LARVOL DELTA

[VIRTUAL] MODULE 3: New Directions in the Management of UBC (ASCO 2021) - "Available data from the Phase I/II CheckMate 032 trial of nivolumab alone or in combination with ipilimumab in the cohort of patients with advanced UBC Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies as first-line therapy for patients with unresectable locally advanced or metastatic UBC Design, eligibility criteria and key endpoints of the ongoing Phase III PROOF 302 trial of the oral FGFR inhibitor infigratinib as adjuvant therapy for patients with MIBC harboring susceptible FGFR3 alterations Published research findings and ongoing evaluations of other FGFR-targeted agents (eg, pemigatinib, rogaratinib, vofatamab, LY3076226, futibatinib) in UBC Clinical rationale for the ongoing evaluation of enfortumab vedotin in combination with an immune checkpoint inhibitor as neoadjuvant therapy for cisplatin-eligible patients with MIBC (KEYNOTE-B15/EV-304) Potential role of the antibody-drug..."

Immune Modulation • Inflammation • Oncology • FGFR3 • ICOS

A phase 1 study of LY3076226, a fibroblast growth factor receptor 3 (FGFR3) antibody-drug conjugate, in patients with advanced or metastatic cancer. (PubMed, Invest New Drugs) - P1 | "Dose escalation of LY3076226 beyond 5.0 mg/kg in patients with advanced tumors may be possible. The trial was registered on August 19, 2015 under identifier NCT02529553 with ClinicalTrials.gov."

Clinical • Journal • P1 data • Oncology • Solid Tumor • Urothelial Cancer • FGFR3

A Study of LY3076226 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: Eli Lilly and Company; N=37 ➔ 25

Clinical • Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

LY3076226, a novel anti-FGFR3 antibody drug conjugate exhibits potent and durable anti-tumor activity in tumor models harboring FGFR3 mutations or fusions (AACR 2019) - "LY3076226 was also efficacious after 4 weekly treatments at 5 mg/kg, resulting in tumor growth inhibition, tumor stasis or tumor regressions in bladder PDX models with G370C, S249C or R248C FGFR3 mutations, respectively. Additionally, LY3076226 exhibited superior efficacy compared to the naked IMC-D11 Ab or chKTI-ADC controls.These data support the conclusion that therapy with FGFR3 targeted antibody-drug conjugate LY3076226 may confer tumor control in patients that are FGFR3 positive and harbor FGFR3 mutations or fusion proteins."