Perspective Therapeutics, Inc.（CATX）资讯与事件CATXPerspective Therapeutics, Inc.

Perspective Therapeutics Announces Interim Results of [212Pb]VMT-alpha-NET Clinical Trial

Perspective Therapeutics announced new interim results from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-alpha-NET in patients with unresectable or metastatic somatostatin receptor type 2 expressing neuroendocrine tumors. These data are being presented as a rapid oral presentation at the European Society for Medical Oncology Congress 2026 taking place October 23-27, 2026 in Madrid, Spain. Neuroendocrine tumors are diagnosed in more than 12,000 people in the United States each year, and approximately 90% of gastroenteropancreatic NETs express SSTR2, the target of [212Pb]VMT-alpha-NET. In the ongoing Phase 1/2a study in patients with SSTR2-positive NETs who had not received prior radiopharmaceutical therapy, the objective response rate, including unconfirmed responses, was 33% in Cohort 2 and 50% in Cohort 3. For GEP-NETs patients with SSTR2 expression in all target lesions, responses were seen in 14 of 38 Cohort 2 patients, and in eight of 17 Cohort 3 patients. Disease control rate was 89% and 95% in Cohorts 2 and 3, respectively, and progression-free survival was 72% at 18 months across all cohorts. No dose-limiting toxicities, Grade 4 or 5 treatment-emergent adverse events, or adverse event-related treatment discontinuations were reported. We aim to complete Phase 3 site start-up preparations around year-end 2026, positioning us to rapidly activate clinical sites following an End-of-Phase 2 meeting with the FDA, with Phase 3 initiation expected in 2027. The presentation provided initial cohort-level safety data in Cohorts 1, 2, and 3 of the study, as well as updated efficacy results from both patients in Cohort 1, and initial results from all 46 patients in Cohort 2 and all 20 patients in Cohort 3. The analysis data cut-off date was September 2, 2026, approximately 20 weeks after the ASCO 2026 data cut-off date. Durable disease control: PFS rate was 86% at six months, 74% at 12 months, and 72% at 18 months across Cohorts 1, 2, and 3. Cohort 2: Robust tumor response observed. Fifteen out of 46 patients experienced an initial response; 14 of those responses were confirmed. One patient experienced an initial response 72 weeks after their first treatment, remains on study, and is expected to receive subsequent tumor assessment. A further 13 patients with stable disease in Cohort 2 remain in study as of September 10, 2026. Cohort 3: Higher responses were observed in Cohort 3 relative to Cohort 2 at early assessments. Ten out of 20 patients in Cohort 3 experienced an initial response, with eight responses occurring as of September 2, 2026 and two more reported as of September 10, 2026. Five of those responses were confirmed as of September 2, 2026, and an additional response was confirmed as of September 10, 2026. All four patients with responses pending confirmation remain on study and are expected to receive subsequent tumor assessment. A further eight patients with stable disease in Cohort 3 remain in study as of September 10, 2026. GEP-NET patients whose target lesions all express SSTR2: Responses were seen in 14 of 38 Cohort 2 patients, and in eight of 17 Cohort 3 patients. Safety: No dose-limiting toxicities and no discontinuations due to adverse events [212Pb]VMT-alpha-NET continues to be well-tolerated. There were no reports of DLTs, no treatment-related discontinuations, and no serious adverse events related to the study medication during the TEAE window at this point in the study. A low incidence of high-grade TEAEs was observed, all of which were Grade 3. No dysphagia and no myelodysplastic syndrome were reported. Two patients had Grade 3 renal events, and renal function continues to be characterized over longer follow-up.

Perspective Therapeutics Receives FDA Fast Track Designation for PSV359

Perspective Therapeutics announced that the FDA granted Fast Track Designation for the development of PSV359 for adult patients with locally advanced unresectable and/or metastatic fibroblast activation protein, or FAP, -positive solitary fibrous tumors, or SFTs. SFT is a rare cancer for which patients with locally advanced unresectable or metastatic disease have limited treatment options. PSV359 is an investigational FAP-targeted alpha-particle therapy being evaluated in an ongoing Phase 1/2a study in patients with advanced FAP-positive solid tumors. Early human imaging data for PSV359 support strong tumor uptake and fast renal clearance.

Perspective Therapeutics Announces Clinical Trial Collaboration Agreement with Merck

Perspective Therapeutics (CATX) announced a clinical trial collaboration agreement with Merck (MRK). The agreement supports the evaluation of Perspective's targeted alpha-particle therapy PSV359 in combination with Keytruda, Merck's anti-PD-1 therapy. This combination will be evaluated under an amendment to the company's ongoing Phase 1/2a study of PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha. The study has completed enrollment in the first three monotherapy dose cohorts. Perspective is sponsoring the study, and Merck is providing pembrolizumab at no cost.