On April 25, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that abstracts related to trials of the company’s lead therapeutic, vofatamab, have been accepted for presentation at the upcoming 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 31 to June 4, 2019 in Chicago, Illinois (Press release, Rainier Therapeutics, APR 25, 2019, View Source [SID1234535401]).

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"We are pleased to have abstracts related to our ongoing Phase 2 vofatamab trials accepted for a poster discussion and poster presentations at ASCO (Free ASCO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes a preliminary analysis of clinical activity in FIERCE-22 and an interim analysis in FIERCE-21."

Poster Discussion & Poster Presentation:

FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.

Abstract: 4511

Poster Discussion Session: Genitourinary (Nonprostate) Cancer
Date/Time: Monday, June 3, 2019, 4:30 PM – 6:00 PM,
Location: Hall D2

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #337
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM,
Location: Hall A

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

Poster Presentation:

Interim analysis of the FIERCE-21 phase 2 (P2) study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Abstract: 4547

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #373
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM
Location: Hall A

Presenter: Begona Mellado, MD, PhD, Hospital Clinic de Barcelona

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-21 and FIERCE-22.

FIERCE-21 is a Phase 2 trial evaluating vofatamab in combination with docetaxel and separately vofatamab as monotherapy in patients with locally advanced or metastatic bladder cancer with FGFR3 mutation/fusions who have relapsed after, or are refractory to, at least one prior line of chemotherapy.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

For additional information on FIERCE-21, please visit www.clinicaltrials.gov (NCT02401542) and for more information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).

Rainier Therapeutics also plans to study vofatamab in non-muscle invasive bladder cancer (NMIBC) – the FIERCE-23 trial.