Supplementary Table from Safety and Efficacy of 90Y-FAPI-46 Radioligand Therapy in Patients with Advanced Sarcoma and Other Cancer Entities

Fendler, Wolfgang P.; Pabst, Kim M.; Kessler, Lukas; Fragoso Costa, Pedro; Ferdinandus, Justin; Weber, Manuel; Lippert, Maria; Lueckerath, Katharina; Umutlu, Lale; Kostbade, Karina; Mavroeidi, Ilektra A.; Schuler, Martin; Ahrens, Marit; Rischpler, Christoph; Bauer, Sebastian; Herrmann, Ken; Siveke, Jens T.; Hamacher, Rainer

doi:10.1158/1078-0432.22486809.v1

Supplementary Table from Safety and Efficacy of ⁹⁰Y-FAPI-46 Radioligand Therapy in Patients with Advanced Sarcoma and Other Cancer Entities

journal contribution

posted on 2023-03-31, 23:44 authored by Wolfgang P. Fendler, Kim M. Pabst, Lukas Kessler, Pedro Fragoso Costa, Justin Ferdinandus, Manuel Weber, Maria Lippert, Katharina Lueckerath, Lale Umutlu, Karina Kostbade, Ilektra A. Mavroeidi, Martin Schuler, Marit Ahrens, Christoph Rischpler, Sebastian Bauer, Ken Herrmann, Jens T. Siveke, Rainer Hamacher

Supplementary Table from Safety and Efficacy of ⁹⁰Y-FAPI-46 Radioligand Therapy in Patients with Advanced Sarcoma and Other Cancer Entities

History

ARTICLE ABSTRACT

We report efficacy and safety of 90Y-labeled FAPI-46 (90Y-FAPI-46-RLT) in patients with advanced sarcoma, pancreatic cancer, and other cancer entities. Up to four cycles of radioligand therapy (RLT) were offered to patients with (i) progressive metastatic malignancy, (ii) exhaustion of approved therapies, and (iii) high fibroblast activation protein (FAP) expression, defined as SUVmax ≥ 10 in more than 50% of tumor. Primary endpoint was RECIST response after RLT. Secondary endpoints included PET response (PERCIST), overall survival (OS), dosimetry, and safety of FAP-RLT. Among 119 screened patients, 21 (18%) were found eligible [n = 16/3/1/1 sarcoma/pancreatic cancer/prostate/gastric cancer; 38% Eastern Cooperative Oncology Group (ECOG) ≥ 2] and received 47 90Y-FAPI-46-RLT cycles; 16 of 21 (76%) patients underwent repeat RLT. By RECIST, disease control was confirmed in 8 of 21 patients [38%; 8/16 (50%) of evaluable patients). There was one partial response (PR) and seven stable diseases after RLT. Disease control was associated with prolonged OS (P = 0.013). PERCIST response was noted in 8 of 21 patients [38%; 8/15 (53%) of evaluable patients]. Dosimetry was acquired in 19 (90%) patients. Mean absorbed dose was 0.53 Gy/GBq in kidney, 0.04 Gy/GBq in bone marrow, and <0.14 Gy/GBq in liver and lung. Treatment-related grade 3 or 4 adverse events were observed in 8 (38%) patients with thrombocytopenia (n = 6) and anemia (n = 6) being most prevalent. 90Y-FAPI-46-RLT was safe and led to RECIST PR in one case as well as stable disease in about one third of patients with initially progressive sarcomas, pancreatic cancer, and other cancers. Discontinuation after the first cycle and a low rate of PR requires future improvement of FAP-RLT.