SIR-Spheres (yttrium-90 microspheres) / SIRTeX Medical - LARVOL DELTA

SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Thomas Jefferson University | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion • Trial completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

MAA-Based Dosimetry for Predicting Tumor Response and Survival Post-TARE in Liver Metastasis Patients (EANM 2025) - "Materials and Methods Population : 145 TARE therapies (SIR-Spheres, Sirtex Medical Europe GmbH, Bonn, Germany) in liver metastasis patients...Results Responders received a significantly higher mean tumor dose (Dmean) (177.2 Gy ± 54.6) compared to non-responders (139.6 Gy ± 48.1; p<0.05). Median OS was 34.6 months for responders vs. 13.5 months for non-responders ( p=0.0175 ) ROC analysis proposed a Dmean cutoff of 122.8 Gy (sensitivity: 0.96, specificity: 0.39) However , patient stratification by this cutoff did not yield a significant OS difference (p=0.173) Conclusion Responders (15%) exhibited both higher Dmean and prolonged OS compared to non-responders A Dmean cutoff of 122.8 Gy was identified as a potential predictor of therapy response, but failed to significantly differentiate OS in this cohort..."

Clinical • Oncology

STRATUM: Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: National Cancer Centre, Singapore | N=176 ➔ 100 | Trial completion date: Oct 2026 ➔ Jan 2028 | Trial primary completion date: Apr 2025 ➔ Jul 2026

Enrollment change • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor • CD4

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (clinicaltrials.gov) - P=N/A | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P1 ➔ P=N/A

Phase classification • Liver Cancer • Oncology • Solid Tumor

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: City of Hope Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Tumor mutational burden • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • PD-L1

NEW INDICATION OF THE GROUP’S GLOBALLY INNOVATIVE RADIOACTIVE PRODUCT SIR-SPHERES Y-90 RESIN MICROSPHERE INJECTION IS OFFICIALLY APPROVED IN EUROPE (HKEXnews) - "The approval of the new indications expands the scope of application of this therapy from unresectable hepatocellular carcinoma ('HCC') and unresectable metastatic liver tumors from primary colorectal cancer ('mCRC') to multiple indications, including unresectable intrahepatic cholangiocarcinoma ('ICC'), hepatic metastases by neuroendocrine tumors ('mNET'), or other liver metastases, covering a more comprehensive classification of primary liver cancer and secondary liver metastasis."

EMA approval • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Neuroendocrine Tumor • Hepatocellular Cancer

Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=11 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Breast Cancer • Oncology • Solid Tumor • PD-L1

Sirtex Medical’s SIR-Spheres Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma (PRNewswire) - "Sirtex Medical...announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S...This regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres in treating HCC."

FDA approval • Hepatocellular Cancer

Dosimetry in safety assessment of elevated pulmonary doses from radionuclide therapies (SNMMI 2025) - " Retrospective review of the dosimetric analysis and follow up of four patients who underwent therapy with [177Lu] Lu-PSMA-617, [177Lu] Lu-DOTATATE, [131I] NaI, and [90Y] SIR-Spheres® was done. 1. A 73-year-old-male with a history of papillary thyroid cancer treated with thyroidectomy and [131I] NaI therapy 19 years ago (therapeutic activity currently unknown) presented with diffuse iodine avid metastases to the lungs underwent pretreatment imaging and dosimetry with [131I] NaI. Lung uptake was measured to be 45% at 48 hours post-administration."

Clinical • Castration-Resistant Prostate Cancer • Endocrine Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Pulmonary Disease • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Budget Impact of Shifting the Treatment Setting of Unresectable Liver Metastases Associated with Primary Colorectal Cancer Using Y-90 Resin Microspheres from the Outpatient Hospital to the Office-Based Laboratory. (PubMed, Clinicoecon Outcomes Res) - "In sensitivity analyses, annual cost savings for the health plan were affected by both the proportion of patients shifted and the setting they were shifted into. Shifting a percentage of the treatment of unresectable liver metastases with Y-90 SIRT to the OBL setting results in modest cost benefits for US health plans."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor

SIRCCA: SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2/3 | N=89 | Terminated | Sponsor: Sirtex Medical | Completed ➔ Terminated; Slow enrollment

Trial termination • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial. (PubMed, J Patient Rep Outcomes) - P2 | "Combining SIRT with nivolumab did not compromise HRQoL in patients with unresectable HCC. Study results were limited by the small number of patients but, combined with the previously reported clinical outcomes, suggested that the treatment combination deserves further consideration in this difficult-to-treat population."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2025 ➔ Jan 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Hepatology • Liver Cancer • Oncology • Solid Tumor

Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=11 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Breast Cancer • Hepatology • Oncology • Solid Tumor

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

IO biomarker • Trial completion date • Trial primary completion date • Tumor mutational burden • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • PD-L1 • TMB

Safety and Efficacy of Selective Internal Radiation Therapy for Portal Vein Tumour Thrombus in Advanced Hepatocellular Carcinoma: A Single-Centre Experience in Australia. (PubMed, J Med Imaging Radiat Oncol) - "Our cohort suggests that SIRT is a safe and effective treatment option for a difficult-to-treat patient population. Our data suggest a longer OS for those with preserved liver function, good functional status and low AFP levels at 21.2 months. Poor pre-treatment liver function and functional status are predictors of decompensation, and decompensation is a predictor of poor survival. These data provide an Australasian perspective and support the expanding role of SIRT in HCC treatment guidelines. Further prospective studies with larger sample sizes and longer follow-up are warranted to confirm these findings."

Journal • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Solid Tumor • Thrombosis

Dosimetry Assessment in Predicting Treatment Outcomes Following Yttrium-90 Transarterial Radioembolization of Hepatic Tumors. (PubMed, Cancer Biother Radiopharm) - "Purpose: To evaluate the use of yttrium-90 (Y90) dosimetry in predicting treatment outcomes when used following transarterial radioembolization with SIR-Spheres® (Resin Y90) in patients with hepatic tumors...Time to death and mean dose to nontumor was associated in hepatocellular carcinoma patients (p = 0.0421), but not the colorectal carcinoma or other subgroup. Voxel-based dosimetry assessment is a tool that may be utilized to assist in predicting treatment outcomes in responders to transarterial radioembolization."

Journal • Colorectal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

SirTac: Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis (clinicaltrials.gov) - P2 | N=108 | Completed | Sponsor: Charite University, Berlin, Germany | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Jul 2022 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study. (PubMed, Cardiovasc Intervent Radiol) - "In our cohorts, patients performed similarly regarding clinical outcomes irrespective of their analysis group based on reimbursement recommendations. Our results suggest that instead of restrictive reimbursement criteria, more decision-making power in selecting suitable patient groups could be given to multidisciplinary tumour boards. Results confirm that TARE with Y90 resin microspheres is an effective and safe treatment for liver cancer, with maintained HRQoL in most patients."

Journal • Observational data • Reimbursement • US reimbursement • Colorectal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: GrandPharma (China) Co., Ltd.

New trial • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Initial Outcomes of Integrating Yttrium-90 Radioembolization with Capecitabine-Temozolomide for Grade 3 Liver-Dominant Metastatic Neuroendocrine Tumors (NANETS 2024) - "Resin Y90 microspheres (SIR-Spheres) were administered using the body surface area method. CONCLUSIONS Integrated CapTemY90 chemotherapy and radioembolization showed acceptable toxicity, not greater than expected in this cohort of patients with G3 NETs. Hepatic and overall PFS suggest improved outcomes compared to that reported in the literature for G3 NETs treated with standard embolotherapy, noting that ours is a small cohort."

Metastases • Anemia • Endocrine Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thrombocytopenia

Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres (clinicaltrials.gov) - P=N/A | N=1 | Completed | Sponsor: Methodist Health System | Recruiting ➔ Completed | N=300 ➔ 1

Enrollment change • Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor

Cover it all with SIR-Spheres (CIRSE 2024) - "Sponsored by Sirtex"

Hepatocellular Cancer • Oncology

DOORwaY90: Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Sirtex Medical | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Sirtex Medical Launches SIR-Spheres FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans (PRNewswire) - "Sirtex Medical...announced today the launch of its SIR-Spheres FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer....SIR-Spheres FLEXdose SELECT Delivery Program offers unparalleled flexibility by enabling tailored, patient-specific dosing from a single 3mL delivery vial."

Commercial • Colorectal Cancer