RG7444 / Roche - LARVOL DELTA

Q1 ‘11 conference call (Roche) - RG7444 anti-FGF 19 antibody

Oncology

A phase I dose-escalation study of MFGR1877S, a human monoclonal anti-fibroblast growth factor receptor 3 (FGFR3) antibody, in patients (pts) with advanced solid tumors (EORTC-NCI-AACR 2012) - Presentation time: Friday, Nov 09, 2012; P1, N=26; NCT01363024; The RP2D of MFGR1877S is 30mg/kg; MFGR1877S was well-tolerated with a favorable safety profile, and produced prolonged periods of disease stability in some pts

P1 data • Oncology

FIERCE 21: Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (clinicaltrials.gov) - P1/2; N=300; Active, not recruiting; Sponsor: Rainier Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

FIERCE-22: A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (clinicaltrials.gov) - P1b/2; N=74; Recruiting; Sponsor: Rainier Therapeutics; Trial completion date: Sep 2019 ➔ Sep 2022; Trial primary completion date: Dec 2018 ➔ Dec 2021

Clinical • Combination therapy • PD(L)-1 Biomarker • Trial completion date • Trial primary completion date

FIERCE 21: Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (clinicaltrials.gov) - P1/2; N=300; Recruiting; Sponsor: BioClin Therapeutics, Inc.; Phase classification: P1b/2 ➔ P1/2; Trial completion date: Dec 2019 ➔ Dec 2021; Trial primary completion date: Mar 2019 ➔ Mar 2021

Phase classification • Trial completion date • Trial primary completion date

FIERCE 21: A Phase 1b/2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (clinicaltrials.gov) - P1b/2; N=261; Recruiting; Sponsor: BioClin Therapeutics, Inc.; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Dec 2018 ➔ Mar 2019

Trial completion date • Trial primary completion date