lutetium [177Lu]oxyoctreotide (XTR008) / Sinotau Pharma - LARVOL DELTA

XT-XTR008-3-01: A phase III study of 177Lu-Dotatate versus high-dose octreotide long-acting repeatable (LAR) in patients with advanced grade 1–2, well-differentiated, gastroenteropancreatic neuroendocrine tumours (GEP-NETs) (ESMO 2025) - P3 | "Conclusions XTR008 monotherapy significantly prolonged PFS and improved ORR vs LAR in later-line advanced GEP-NETs of all origins including those from non-midgut, with manageable safety. These data support XTR008 as a new treatment option for this population."

Clinical • Late-breaking abstract • Metastases • P3 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • SSTR

177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase III trial. (PubMed, Ann Oncol) - "XTR008 monotherapy showed superior efficacy versus high-dose long-acting repeatable (LAR) octreotide monotherapy in advanced GEP-NET tumours of all origins in a later-line treatment setting, with manageable safety, supporting its use as a new treatment option."

Journal • P3 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Pharmacokinetics and Dosimetry of 177 Lu-DOTATATE in Patients with Advanced well-differentiated, gastroenteropancreatic neuroendocrine tumours: results from a Sub-study of the phase 3 XT-XTR008-3-01 trial (EANM 2025) - P3 | "Pearson Correlation Analysis indicated a moderate but not statistically significant correlation coefficient (r=0.016, p＞0.05) between tumour absorbed dose and tumour size change. Conclusion PRRT with 177 Lu-DOTATATE showed showed favourable tolerability, PK and dosimetry outcomes in Chinese patients, supporting the potential application of XTR008 in Chinese patients with well-differentiated GEP-NETs."

Clinical • Metastases • P3 data • PK/PD data • Nephrology • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Renal Calculi • Renal Disease • Solid Tumor • SSTR

Core Product–XTR008 (HKEXnews) - "...we have adopted a comprehensive indication strategy to fully explore the potential of XTR008 in SSTR-positive tumors. We are conducting a Phase II clinical trial of XTR008 in patients with advanced SSTR-positive NEN (excluding G1/G2 GEP-NETs), including patients (i) with SSTR-positive G3 GEP-NET, (ii) with SSTR-positive pheochromocytoma and paraganglioma ('PPGL') or (iii) with SSTR-positive NEN (other than GEP-NET and PPGL), encompassing lung-NEN, thymus-NEN, NEN of other origins, and cancer of unknown primary – neuroendocrine neoplasm ('CUP-NEN')."

Trial status • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Paraganglioma • Pheochromocytoma

Application Proof of Beijing Sinotau International Pharmaceutical Technology Co., Ltd. (HKEXnews) - P3 | N=196 | NCT05459844 | Sponsor: Sinotau Pharmaceutical Group | "...we submitted an NDA to the NMPA in March 2025 based on the completed interim analysis of a registrational Phase III clinical trial of XTR008 in unresectable or metastatic, progressive, G1 or G2 SSTR-positive gastroenteropancreatic neuroendocrine tumors ('GEP-NETs') in China. The NDA was accepted by the NMPA in April 2025, and we expect to receive NDA approval in 2026...We have observed remarkable efficacy and safety of XTR008 in our registrational Phase III clinical trial. Results of the clinical trial demonstrated that the XTR008 treatment group significantly outperformed the control group receiving standard treatment of high-dose somatostatin long-acting repeatable ('LAR') in terms of multiple efficacy indicators, including progression-free survival ('PFS') and overall response rate."

China approval • China filing • P3 data • Neuroendocrine Tumor