Abstract Library

#4144 Phase Ib portion of the ACTION-1 Phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings

Introduction: RYZ101 (225Ac-DOTATATE) is an alpha-emitting radiopharmaceutical in development for SSTR2+ solid tumors.

Conference:

Presenting Author: Strosberg J

Authors: Strosberg J, Ulaner G, Halperin D, Mehr S, Kotiah S,

Keywords: Gastroenteropancreatic neuroendocrine tumor, Somatostatin analogue therapy, Somatostatin receptor positive, RYZ101,

#4132 ACTION-1: A randomised phase Ib/3 trial of RYZ101 compared with standard of care in somatostatin receptor positive, well-differentiated gastroenteropancreatic neuroendocrine tumors with progression following 177Lu somatostatin analogue therapy

Introduction: Well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are characterized by high-density expression of somatostatin receptors (SSTRs). RYZ101 (225Ac-DOTATATE) is a highly potent alpha-emitting radiopharmaceutical therapy (RPT) being developed for SSTR+ solid tumors. ACTION-1 is a 2-part, global, randomized, controlled, open-label, Phase 1b/3 trial of RYZ101. Part 1 (Phase 1b), an uncontrolled dose de-escalation study, is complete with no dose-limiting toxicities.

Conference:

Presenting Author: Singh S

Authors: Singh S, Tesselaar M, Strosberg J, Jacene H, Halperin D,

Keywords: RYZ101, Gastroenteropancreatic neuroendocrine tumor, Somatostatin receptor, Radiopharmaceutical therapy,

#3722 A novel and potent Pb-212 alpha-particle therapy for NETs – Complete responses in mouse models to global clinical translation for NET patients

Introduction: A novel SSTR2 targeted peptide (VMT-alpha-NET) has been developed. Promising preclinical data have led to the initiation of multiple Phase 1 clinical trials in the United States for Pb-203 image-guided Pb-212 based alpha-particle therapy for NETs.

Conference:

Presenting Author: Schultz M

Authors: Schultz M, Johnson F, Li M, Liu D, McDonald M,

Keywords: NET, neuroendocrine tumor, alpha therapy, Pb-212, Pb-203, SPECT,

#3455 Phase 1 study of Intralesional (IL) rose bengal (PV-10), an investigational autolytic immunotherapy

Introduction: Intralesional (IL) rose bengal (PV-10) is an investigational autolytic immunotherapy.

Conference:

Presenting Author:

Authors: Price T, Cehic G, Watcher E, Sebbon R, Neuhaus S,

Keywords: PV-10, immunotherapy, phase 1,

#3273 LIBRETTO-531: Selpercatinib vs standard of care in patients (pts) with multikinase inhibitor-naïve advanced or metastatic RET-mutant (mut) medullary thyroid cancer (MTC)

Introduction: Multikinase inhibitors (MKI) are approved for MTC; however, their efficacy in RETmut MTC is limited due to incomplete RET inhibition and significant toxicity. Selpercatinib (LOXO-292), a highly selective and potent FDA approved inhibitor of RET alterations including M918T, MKI resistance-associated V804M, and others, showed robust, durable clinical activity with a tolerable profile in pts with RETmut MTC in the Phase 1/2 LIBRETTO-001 study.

Conference: 18th Annual ENETS Concerence (2021)

Presenting Author:

Authors: Leboulleux S, Robinson B, Hoff A, Brose M, Wirth L,

Keywords: RET alteration, medullary thyroid cancer (MTC), phase 3 trial, selpercatinib,