177Lu-rosopatamab tetraxetan (TLX591) / Telix, BZL Biologics, China Grand Pharma - LARVOL DELTA

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives (GlobeNewswire) - "Key findings include: Tolerability profile supported by dosimetry and low-grade non-hematologic events; Lesion dosimetry indicates no difference in absorbed dose profile across cohorts; No adverse drug-drug interactions observed in TLX591-Tx combinations; Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts; The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy....Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S."

FDA event • P3 data • Castration-Resistant Prostate Cancer

PROSTACT: The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only (clinicaltrials.gov) - P3 | N=16 | Terminated | Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd | N=392 ➔ 16 | Trial completion date: Dec 2028 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2025 ➔ Jul 2025; Telix is conducting a separate Phase 3 clinical trial - ProstACT Global NCT06520345- to expedite the development and approval process under an IND. Consequently, this necessitates the closure of the current 177Lu-TLX591-002 Phase 3 trial.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Final results of a phase I/II dose-escalation study of fractionated dose 177 Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer (mCRPC). (ASCO 2024) - P1/2 | "29 (58%) with prior >2 ARPI, 29 (58%) with >1 chemo, 14 (28%) with Ra-223, 2 (4%) with 177 Lu-J591... A single-cycle of fractionated-dose 177Lu-PSMA-617 is safe. Despite no pre-selection for PSMA expression, most had PSA decline with favorable PFS and OS compared to historical controls and similar to PSMA-selected targeted radionuclide studies administering multiple cycles in a less dose-intense approach."

Clinical • Metastases • P1/2 data • Anemia • Fatigue • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Neutropenia • Oncology • Pain • Prostate Cancer • Solid Tumor • Thrombocytopenia • Xerostomia • FOLH1

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus SoC vs SoC alone in patients with metastatic castration-resistant prostate cancer (SUO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...This study is sponsored by Telix Pharmaceuticals and is currently enrolling in Part 1. ClinicalTrials.gov ID: NCT06520345 "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global: A Phase 3 Study of Lutetium (Lu177) Rosopatamab Tetraxetan plus Standard of Care vs. Standard of Care Alone in Patients with Metastatic Castration-Resistant Prostate Cancer (ASTRO 2025) - "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14 days apart, of 177Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings... TBD"

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT GLOBAL: A phase 3 study of best standard of care with and without 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drug. (ASCO-GU 2024) - P3 | "Eligible patients must have received prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. Secondary endpoints include 5-year overall survival, tumor objective response rate, time to symptomatic skeletal event, progression free survival, and number of participants with treatment-related adverse events. Clinical trial information: NCT04876651."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A PHASE 3 STUDY OF 177LU-TLX591 PLUS SOC VS SOC ALONE IN PATIENTS WITH MCRPC (PROSTACT GLOBAL) (SUO 2024) - "SoC may be an alternative ARPI or docetaxel. This study is currently enrolling. "

Clinical • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer. (ASCO-GU 2025) - P2 | "Exploratory endpoints include: rPFS, ORR, and DOR via RECIST v1.1 (PCWG3-modified where appropriate), genomic and imaging biomarker nomination. Enrollment began in August 2024."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, tolerability, and dosimetry of 177Lu-TLX591 with best standard of care in patients with PSMA-expressing metastatic castration-resistant prostate cancer (ProstAct-SELECT). (ASCO-GU 2024) - P1 | "The primary endpoints include the absorbed radiation dose of administered 177Lu-TLX591 to kidneys, liver, lungs, spleen, bone/red marrow, and salivary glands; tumour-to-healthy tissue ratios and residence times; and type, frequency, and severity of TEAEs. Clinical trial information: NCT04786847."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global Phase 3 Update: First Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed (Telix Press Release) - "Telix Pharmaceuticals...announces that the first patient has been dosed in Part 2 (randomized treatment expansion) of its ProstACT Global Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration resistant prostate cancer (mCRPC). The patient was dosed at the Australian Prostate Centre (APC) in Melbourne, Australia....Telix will submit Part 1 data to the United States (U.S.) Food and Drug Administration (FDA) to enable clearance to expand Part 2 of the trial to U.S. sites. A public disclosure of preliminary results from Part 1 of the study will be aligned to engagement with the FDA."

FDA event • P3 data • Trial status • Castration-Resistant Prostate Cancer

ANALYSIS OF KETOCONAZOLE INDUCED SUPPRESSION OF ADRENAL HORMONES AND ITS CLINICAL IMPLICATIONS FOR PATIENTS WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER TREATED WITH PSMA-TARGETED RADIONUCLIDE THERAPY (SUO 2025) - "All patients received keto (400 mg TID) with HC and were randomized 2:1 to either 177 Lu-J591 or 111 In-J591 after 1 month of keto/HC. Ketoconazole with hydrocortisone therapy in patients with high risk M0 CRPC results in androgen suppression, with pre-treatment testosterone and androstenedione associated with outcomes."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Long-term adverse events (AEs) in PSMA targeted radionuclide therapy (TRT) for castration-resistant prostate cancer (CRPC) (ESMO 2025) - P1, P1/2, P2, P3 | "59 patients received 177Lu-J591 (51%), 19 (16%) 177Lu-PSMA-617, 25 (22%) 225Ac-J591, 8 (7%) 225Ac-J591 + 177Lu-PSMA-I&T, 4 (3%) 177Lu-PSMA-I&T, and 1 (1%) 90Y-J591. Table: 2404P Category of adverse events (AEs) by grade and number of cases attributed to a cause other than PSMA-targeted radionucleotide therapy AE Type AE (%) Grade 1 (n) Grade 2 (n) Grade 3 (n) Grade 4 (n) Alternate cause in AEs Grades 3-4 (%) Kidney Injury 32 (28) 6 19 3 4 5/7 (71) Elevated trasnaminases 40 (34) 25 12 0 3 2/3 (66) Elevated bilirubin 16 (14) 4 5 3 4 6/7 (86) Neutropenia 11 (9) 5 2 1 3 4/4 (100) Thrombocytopenia 57 (49) 24 14 10 9 18/19 (95) Anemia 79 (68) 34 24 17 4 19/21 (90) Conclusions To our knowledge, this is the largest updated study of long-term AEs on prospective trials of PSMA-TRT. Secondary cancers and renal, liver, and marrow toxicities exist, but are not commonly observed."

Adverse events • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Real-world treatment patterns in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitor (ARPI) or docetaxelProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (PCF 2025) - "BACKGROUND: Patients with mCRPC whose disease progressed on an ARPI have a poor prognosis, with median overall survival of <2 years (Sayegh, Eur Urol Focus 2023). These real-world data show that ARPIs remain the most common 1L and 2L treatment in patients with mCRPC despite prior ARPI and/or docetaxel alongside androgen deprivation therapy for mHSPC or nmCRPC. TABLE. Treatment regimens by line of therapy in patients with mCRPC 1L regimen (N=510), 2L regimen (N=188), 3L regimen (N=80), n (%) n (%) n (%) ARPI*,† 289 (56.7) ARPI*,† 83 (44.1) Taxane‡ 23 (28.8) Abiraterone 149 (29.2) Abiraterone 35 (18.6) ARPI*,† 21 (26.3) Enzalutamide 124 (24.3) Enzalutamide 34 (18.1) Enzalutamide 10 (12.5) Taxane‡ 86 (16.9) Taxane‡ 50 (26.6) Abiraterone 8 (10.0) Abiraterone + Cabazitaxel + 16 (3.1) Olaparib 9 (4.8) 8 (10.0) Docetaxel Carboplatin 1 Olaparib 16 (3.1) Lutetium-177 7 (3.7) Lutetium-177 6 (7.5) Abiraterone + Sipuleucel-T 15 (2.9) 4 (2.1) Radium-223 5 (6.3) Sipuleucel-T Other..."

Clinical • HEOR • Metastases • P3 data • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global: A phase 3 study of lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (ESMO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...Legal entity responsible for the study Telix Pharmaceuticals. Funding Telix Pharmaceuticals."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (EANM 2025) - No abstract available

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix Announces Record-Breaking Presence at EANM 2025 (PRNewswire) - "'Telix presentation highlights include the Phase 3 ProstACT Global trial of TLX591 in mCRPC, the IPAX-Linz and IPAX-2 therapeutic trials of TLX101 in glioma, and real-world experience with TLX250-CDx in ccRCC. Telix will host a sponsored symposium on CAIX and FAP targeting theranostics, and abstracts will also be presented from Telix's pan-tumor programs and its Rhine Pharma subsidiary, whose mission is to expand global access to innovative cancer imaging and therapy.'"

Clinical data • Preclinical • Trial status • Castration-Resistant Prostate Cancer • Glioblastoma • Ovarian Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (DGU 2025) - "In Part 1, patients receive 2 IV injections, 76 mCi each 14d apart, of 177Lu-rosopatamab with standard of care (SoC) combinations abiraterone, enzalutamide, or docetaxel (n=10 each) to characterize biodistribution & safety profiles of 177Lu-rosopatamab+SoC combinations...In Part 2, patients are enrolled 2:1 to receive SoC (determined pre-randomization) with or without 2 injections of 76 mCi each of 177Lu-rosopatamab, given 14d apart.Eligible patients must have PSMA+ mCRPC & have experienced disease progression on a minimum 12w prior therapy on their 1st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide)...Additional secondary endpoints include 5-year OS, tumor ORR, time to SSE, & HRQoL. An alpha control & 95% confidence intervals will be used; patients will be randomly assigned to receive 177Lu-rosopatamab+SoC or SoC alone.This study is currently enrolling & is sponsored by Telix Pharmaceuticals."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (SNMMI 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 milicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes... Effective treatment options for mCRPC with favorable safety and tolerability profiles continue to be an unmet need. Combining the advantages of targeted radiotherapy and immunotherapy, along with proven patient selection capabilities of 68Ga-PSMA-11 PET, provides reasonable justification for further evaluation of 177Lu-rosopatamab in a..."

Clinical • Combination therapy • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (SNMMI 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 milicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes... Effective treatment options for mCRPC with favorable safety and tolerability profiles continue to be an unmet need. Combining the advantages of targeted radiotherapy and immunotherapy, along with proven patient selection capabilities of 68Ga-PSMA-11 PET, provides reasonable justification for further evaluation of 177Lu-rosopatamab in a..."

Clinical • Combination therapy • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA-Positive Castration-Resistant Prostate Cancer (SNMMI 2025) - "(No results as per Trials in Progress format)."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA-Positive Castration-Resistant Prostate Cancer (SNMMI 2025) - "(No results as per Trials in Progress format)."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix Theranostic Programs and Satellite Symposia on Innovation in PSMA and CAIX Imaging Featured at SNMMI 2025 (Telix Press Release) - "Presentation highlights include the ProstACT Global Phase 3 study of TLX591 in advanced prostate cancer, preclinical data on Telix’s TLX252 alpha therapy candidate in CAIX expressing tumors in combination with DDRIs, and clinical study data on Illuccix impact on decision-making. Two sponsored symposia will highlight innovation in precision diagnostics, the first on CAIX-PET imaging in renal cancer, and the second on Illuccix PSMA-PET imaging in prostate cancer, including Telix’s new PSMA biopsy trial."

Clinical data • Preclinical • Bladder Cancer • Castration-Resistant Prostate Cancer • Kidney Cancer

CUPID (64Cu-TLX592 phase I PK, biodistribution and dosimetry): A proof-of-concept study of TLX592 targeted alpha therapy in prostate cancer. (ASCO 2025) - P1 | " TLX592 blood clearance was more rapid than TLX591 (T½=19.86+1.96, T½=33.65+11.04h, resp.) with similar organ uptake. Preliminary results demonstrate successful proof-of-concept of RADmAb technology, intended for use with therapeutic alpha-emitting radionuclides. Rapid antibody clearance has potential to minimize radiation exposure & augment the safety & tolerability profile of antibody-based therapies. Residence times (mean±SD) MBq.hr.MBq-1."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 3 study of 177Lu-rosptamab plus standard of care vs. standard of care alone in patients with metastatic castration-resistant prostate cancer (ProstACT Global). (ASCO 2025) - P3 | "Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. An alpha control and 95% confidence intervals will be used; patients will be substratified between TLX591 + 2nd ARPI or TLX591 + docetaxel. This study is currently enrolling."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix at ANZSNM Annual Scientific Meeting 2025 (PRNewswire) - "Telix Pharmaceuticals Limited...announces a strong presence at the 55th Annual Scientific Meeting of the Australian and New Zealand Society of Nuclear Medicine (ANZSNM ASM 2025), to be held in Melbourne, Australia from 23–25 May 2025....Demonstrating its commitment to development and education in theranostics, Telix presentations include: ProstACT Global Phase 3 study of TLX591 (177Lu-rosopatamab tetraxetan), Telix's first-in-class PSMA targeting radio antibody-drug conjugate (rADC) therapy candidate; STARSTRUCK study of TLX250 (177Lu-girentuximab) in combination with peposertib in patients with carbonic anhydrase IX (CAIX)-expressing solid tumors, and a preclinical evaluation of 225Ac-girentuximab in combination with DNA damage response inhibition..."

Clinical data • Preclinical • Castration-Resistant Prostate Cancer