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Highlights from The American Society of Clinical Oncology 2026 Annual Meeting
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| Real-World Overall Survival Outcomes of Lutetium (Lu177) Vipivotide Tetraxetan Treatment in Prostate Cancer
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| Antonio Faieta, MD
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| In this large real-world cohort of 6,464 mCRPC patients starting Lu177 vipivotide tetraxetan, overall survival was 85.4% at 6 months, 67.2% at 12 months, 42.8% at 24 months, and 23.8% at 36 months, similar to VISION trial outcomes. Survival was strongly predicted by comorbidity burden and tobacco use (worse) and by baseline markers of physiologic reserve—higher albumin, hemoglobin, RBC, total protein, lymphocyte/eosinophil counts were associated with better OS, while higher RDW, neutrophils, and inflammatory ratios predicted worse OS.
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| ProTACT: Preliminary Data from a First-in-Human Phase 1 Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of [225Ac]Ac-FL-020, a PSMA-Targeted Radioconjugate, in Patients with mCRPC
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| Alison Zhang
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| ProTACT is a first-in-human phase 1 trial of [²²⁵Ac]Ac-FL-020, a PSMA-targeted alpha radioconjugate designed to improve tumor uptake and reduce off-target salivary/renal toxicity using UniRDC™ technology. In 15 heavily pretreated mCRPC patients escalated to 5 MBq/cycle, no dose-limiting toxicities were observed; the most common AEs were fatigue, nausea, and dry mouth, with grade ≥3 events rare and two hematologic grade 3 events attributed to disease progression rather than treatment, and no renal toxicity seen.
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| Canadian Cancer Trials Group (CCTG) Study PR21 (PLUDO): Results of Crossover Treatment from a Randomized Trial of 177Lu-PSMA vs Docetaxel in Patients with mCRPC
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| Kim Chi, MD
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| The PLUDO crossover analysis showed no significant difference in outcomes between sequencing 177Lu-PSMA then docetaxel versus docetaxel then 177Lu-PSMA in ARPI-pretreated mCRPC: from randomization, rPFS2 was 18.5 vs 15.8 months and OS was 23.2 vs 20 months; from crossover, subsequent PFS was 4.8 vs 5.4 months and OS 8.1 vs 8.3 months. PSA ≥50% declines were higher when crossing to docetaxel after LuPSMA, and toxicity profiles were consistent with each therapy, supporting either sequence after ARPI.
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| Subgroup Analyses by Disease Volume and De Novo/recurrent mHSPC in the PSMAddition Study of Lutetium-177
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| Fred Saad, MD, FRCS
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| PSMAddition subgroup analyses showed that adding lutetium-177 to ADT + ARPI provided a consistent rPFS benefit across disease volume and timing subgroups in PSMA-positive mHSPC: high-volume HR 0.72, low-volume HR 0.73, de novo HR 0.74, and recurrent HR 0.74. Similar benefits were seen for time to PSA progression and time to mCRPC, with patient-reported outcomes and safety profiles consistent across subgroups and matching the overall trial results.
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| Safety and Dosimetry of 177Lu-Rosopatamab Tetraxetan + Standard of Care in Patients with mCRPC: Preliminary Results from Part 1 of Phase 3 ProstACT Global Study
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| Pedro Barata, MD, MSc, FACP
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| In part 1 of the phase 3 ProstACT Global study, the PSMA-targeted radiotherapeutic antibody 177Lu-rosopatamab tetraxetan (TLX591-Tx) given as two 76 mCi doses 14 days apart plus standard of care was feasible and well tolerated in 36 mCRPC patients, with no new safety signals and predominantly transient hematologic toxicities (notably thrombocytopenia, neutropenia, and lymphopenia) and low-grade xerostomia.
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| AcTION: Phase 1 Study of 225Ac-PSMA-617 in Men with mCRPC with or Without Prior Lutetium-177-PSMA Radioligand Therapy
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| Louise Emmett, MD, MBChB, FRACP, FAANMS
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| The AcTION phase 1 trial showed that 225Ac-PSMA-617, an alpha-emitting PSMA radioligand using the same ligand as 177Lu-PSMA, is safe and active up to 10 MBq every 8 weeks in PSMA-positive mCRPC, with no dose-limiting toxicities, no grade 4–5 treatment-related events, and dry mouth as the most common adverse event without clear dose dependence. PSA and radiographic responses were observed across all groups, with the most favorable activity seen in chemotherapy/ARPI-naïve patients and meaningful activity even after prior 177Lu-PSMA.
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| CONVERGE-01 Part 3: Ac-225 Rosopatamab Tetraxetan (CONV01-α) in 177Lu-PSMA Pretreated mCRPC
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| Michael Morris, MD
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| CONVERGE-01 Part 3 showed that a single two-dose cycle of 225Ac-rosopatamab tetraxetan (CONV01-α) is safe and active in mCRPC patients previously treated with 177Lu-PSMA, with no dose-limiting toxicities up to 55 kBq/kg and no high-grade xerostomia or nephrotoxicity. Hematologic toxicities were predictable, dose-related, and clinically manageable without transfusion dependence or treatment discontinuations, and dosimetry confirmed low salivary gland/kidney exposure with liver uptake.
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