Clovis Oncology Highlights Updated LuMIERE Phase 1 Data of Targeted Radiotherapy Candidate FAP-2286 at the 35th Annual EANM Congress

BOULDER, Colo.--(BUSINESS WIRE)--Oct 17, 2022--

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral presentation at the 35 th Annual European Association of Nuclear Medicine Congress (EANM) detailing updated Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study (NCT04939610) investigating the safety, pharmacokinetics, dosimetry, and preliminary anti-tumor activity of its targeted radiotherapy candidate, FAP-2286 labeled with lutetium-177 ( 177 Lu-FAP-2286). Overall, in eleven patients treated in the first three dose cohorts, 177 Lu-FAP-2286 demonstrated a manageable safety profile and encouraging evidence of anti-tumor activity, including previously reported confirmed partial response (PR) per RECIST in one patient and an additional patient with RECIST stable disease (SD) through cycle four of treatment. This dataset will be presented in an oral presentation by Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial.

FAP-2286 targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types. FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP to enter clinical development and is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent 177 Lu-FAP-2286 to identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent 68 Ga-FAP-2286 is also being evaluated, with plans for Phase 2 expansion cohorts in multiple tumor types to initiate in Q1 2023.

“The LuMIERE trial is the first prospective trial of a FAP peptide targeted radionuclide therapy and is currently in the dose escalation phase. To date we have not seen evidence of significant associated toxicities that would limit therapy, and have seen some evidence of early efficacy,” said Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial. “We are excited about these results and the fact that FAP is expressed across a number of tumor types, and we look forward to seeing the future results.”