Perspective Therapeutics Continues to Pursue Dose Escalation of [212Pb]VMT-α-NET in its Ongoing Phase 1/2a Clinical Trial Based on Updated Interim Data Presented at the 2025 ASCO Gastrointestinal Cancers Symposium
Perspective Therapeutics (NYSE: CATX) presented updated interim results from its Phase 1/2a clinical trial of [212Pb]VMT-α-NET at the 2025 ASCO Gastrointestinal Cancers Symposium. The trial focuses on patients with unresectable or metastatic SSTR2-expressing neuroendocrine tumors.
Key findings from nine patients in Cohorts 1 (2.5 mCi) and 2 (5.0 mCi) show: no dose-limiting toxicities, favorable safety profile, and promising efficacy. Three of seven patients in Cohort 2 experienced objective responses, with one confirmed response lasting 17 weeks. Five patients maintain stable disease.
The Safety Monitoring Committee supported proceeding with Cohort 3 dose escalation and expanding Cohort 2 enrollment. As of December 31, 2024, 18 patients have been dosed in Cohort 2. The company awaits FDA alignment before proceeding with Cohort 3.
Perspective Therapeutics (NYSE: CATX) ha presentato risultati interim aggiornati dal suo studio clinico di fase 1/2a su [212Pb]VMT-α-NET al Simposio sui Tumori Gastrointestinali ASCO 2025. Lo studio è rivolto a pazienti con tumori neuroendocrini esprimenti SSTR2, non resecabili o metastatici.
I risultati principali provenienti da nove pazienti nei Coorti 1 (2,5 mCi) e 2 (5,0 mCi) mostrano: nessuna tossicità dose-limite, un profilo di sicurezza favorevole e un'efficacia promettente. Tre dei sette pazienti nel Coorte 2 hanno mostrato risposte obiettive, con una risposta confermata che è durata 17 settimane. Cinque pazienti mantengono la malattia stabile.
Il Comitato di Monitoraggio della Sicurezza ha sostenuto di procedere con l'aumento della dose nel Coorte 3 e di espandere l'arruolamento nel Coorte 2. Fino al 31 dicembre 2024, 18 pazienti sono stati trattati nel Coorte 2. L'azienda attende un allineamento con la FDA prima di procedere con il Coorte 3.
Perspective Therapeutics (NYSE: CATX) presentó resultados interinos actualizados de su ensayo clínico de fase 1/2a sobre [212Pb]VMT-α-NET en el Simposio sobre Cánceres Gastrointestinales ASCO 2025. El ensayo se centra en pacientes con tumores neuroendocrinos que expresan SSTR2, irresecables o metastásicos.
Los hallazgos clave de nueve pacientes en los Grupos 1 (2,5 mCi) y 2 (5,0 mCi) muestran: ninguna toxicidad limitante de dosis, un perfil de seguridad favorable y una eficacia prometedora. Tres de siete pacientes en el Grupo 2 experimentaron respuestas objetivas, con una respuesta confirmada que duró 17 semanas. Cinco pacientes mantienen la enfermedad estable.
El Comité de Monitoreo de Seguridad apoyó continuar con la escalada de dosis del Grupo 3 y expandir la inscripción del Grupo 2. Hasta el 31 de diciembre de 2024, se han tratado 18 pacientes en el Grupo 2. La empresa espera alineamiento con la FDA antes de proceder con el Grupo 3.
Perspective Therapeutics (NYSE: CATX)는 2025 ASCO 소화기암 심포지엄에서 [212Pb]VMT-α-NET 1/2a상 임상 시험의 업데이트된 중간 결과를 발표했습니다. 이 시험은 절제가 불가능한 또는 전이성 SSTR2 발현 신경내분비 종양 환자에 초점을 맞추고 있습니다.
1군(2.5 mCi)과 2군(5.0 mCi)의 아홉 환자에서 나온 주요 결과는 다음과 같습니다: 약물 용량 제한 독성 없음, 우호적인 안전성 프로필 및 유망한 효능. 2군의 7명 중 3명이 객관적인 반응을 보였으며, 17주 동안 지속된 확인된 반응이 있습니다. 5명의 환자는 질병이 안정적인 상태를 유지하고 있습니다.
안전 모니터링 위원회는 3군의 용량 증가를 진행하고 2군의 등록을 확대하는 것을 지지했습니다. 2024년 12월 31일 기준으로 2군에서 18명의 환자가 치료를 받았습니다. 회사는 3군 진행 전에 FDA의 조정을 기다리고 있습니다.
Perspective Therapeutics (NYSE: CATX) a présenté des résultats intermédiaires actualisés de son essai clinique de phase 1/2a sur [212Pb]VMT-α-NET au Symposium ASCO 2025 sur les cancers gastro-intestinaux. L'essai concerne des patients présentant des tumeurs neuroendocrines exprimant SSTR2, non résécables ou métastatiques.
Les résultats clés provenant de neuf patients des Cohortes 1 (2,5 mCi) et 2 (5,0 mCi) montrent : aucune toxicité limitant la dose, un profil de sécurité favorable et une efficacité prometteuse. Trois des sept patients dans la Cohorte 2 ont présenté des réponses objectives, avec une réponse confirmée ayant duré 17 semaines. Cinq patients maintiennent une maladie stable.
Le Comité de Surveillance de la Sécurité a soutenu la poursuite de l'escalade de la dose dans la Cohorte 3 et l'expansion de l'inscription dans la Cohorte 2. Au 31 décembre 2024, 18 patients ont été traités dans la Cohorte 2. L'entreprise attend un alignement avec la FDA avant de procéder à la Cohorte 3.
Perspective Therapeutics (NYSE: CATX) hat aktualisierte vorläufige Ergebnisse seiner Phase 1/2a-Studie zu [212Pb]VMT-α-NET auf dem ASCO Symposium zu gastrointestinalen Krebserkrankungen 2025 vorgestellt. Die Studie richtet sich an Patienten mit unresektierbaren oder metastasierenden neuroendokrinen Tumoren, die SSTR2 exprimieren.
Wichtige Ergebnisse von neun Patienten in den Kohorten 1 (2,5 mCi) und 2 (5,0 mCi) zeigen: keine dosislimitierenden Toxizitäten, ein günstiges Sicherheitsprofil sowie vielversprechende Wirksamkeit. Drei von sieben Patienten in Kohorte 2 zeigten objektive Antworten, wobei eine bestätigte Antwort 17 Wochen anhielt. Fünf Patienten haben eine stabile Krankheit.
Der Sicherheitsüberwachungsausschuss unterstützte die Fortsetzung der Dosiserhöhung in Kohorte 3 und die Erweiterung der Rekrutierung in Kohorte 2. Bis zum 31. Dezember 2024 wurden 18 Patienten in Kohorte 2 behandelt. Das Unternehmen wartet auf eine Abstimmung mit der FDA, bevor es mit Kohorte 3 fortfährt.
- Three of seven patients in Cohort 2 showed objective tumor responses
- No dose-limiting toxicities or serious adverse events reported
- Safety Monitoring Committee approved dose escalation to Cohort 3
- Successfully enrolled additional 11 patients in Cohort 2 since August 2024
- One patient showed progressive disease after one dose
- Two of three responses remain unconfirmed
- FDA approval still pending for Cohort 3 progression
Insights
The latest data from Perspective Therapeutics' Phase 1/2a trial reveals several significant positive developments that strengthen the potential of [212Pb]VMT-α-NET in treating neuroendocrine tumors:
Key clinical observations:
- The 43% objective response rate (3/7 patients) in Cohort 2 is particularly noteworthy for this patient population with progressive disease
- The observation of delayed responses after treatment completion suggests potential ongoing therapeutic effects, a characteristic often associated with successful radiopharmaceutical treatments
- The clean safety profile with no DLTs or serious adverse events supports potential for dose escalation
The gradual tumor regression pattern observed in multiple patients is especially intriguing, as it suggests a durable treatment effect that could differentiate this therapy from existing options. The stable disease maintenance in five patients further supports the drug's disease control potential.
The reopening of Cohort 2 with 11 additional patients dosed (total 18 patients) demonstrates strong investigator confidence and robust trial execution. The company's strategic approach of seeking FDA alignment before dose escalation while continuing Cohort 2 enrollment reflects prudent development planning.
The expansion potential and safety profile position [212Pb]VMT-α-NET as a promising candidate in the competitive NET treatment landscape, where there remains significant unmet need for effective therapies with favorable tolerability profiles.
- Updated interim results with an additional 10 weeks of follow-up on the nine patients in Cohorts 1 (2.5 mCi) and Cohort 2 (5.0 mCi) of the ongoing Phase 1/2a study support continuation of dose-finding for [212Pb]VMT-α-NET
- [212Pb]VMT-α-NET continued to have a favorable safety profile, with no dose-limiting toxicities observed at the two doses tested
- Three of seven patients in Cohort 2 experienced investigator-assessed objective responses as defined by RECIST v1.1. First responses for two patients occurred after end of treatment period and are subject to confirmation, in addition to the previously reported patient with confirmed response who remains in response
- The five other patients in Cohorts 1 and 2 who previously experienced stable disease remain in stable disease
SEATTLE, Jan. 24, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, announced updated interim results from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET that are being presented as a poster presentation at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) taking place January 23-25, 2025 in San Francisco, CA.
This Phase 1/2a clinical trial is a multi-center open-label dose escalation and dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapy (RPT) and whose tumors have shown radiological evidence of disease progression in the 12 months prior to enrollment.
Two patients in Cohort 1 and seven patients in Cohort 2 received [212Pb]VMT-α-NET treatment prior to Cohort 2 being reopened in August 2024. These patients were enrolled for dose limiting toxicities observations. Initial results as of a data cut-off date of October 31, 2024 were previously presented at the 2024 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium in November 2024.
As of the data cut-off date for the ASCO-GI poster presentation of January 10, 2025, all nine patients had completed treatments per the study protocol, and at least one scan for all patients after their final treatments was available to the study team.
- Safety findings: No dose limiting toxicities (DLTs), grade 4 or 5 treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) have been reported since the start of the study. No new grade 3 adverse events (AEs) have been observed aside from the two events that were previously reported. No decline in renal function was observed. Hematologic AEs such as decreased lymphocyte count and anemia were all grades 1 and 2. No treatment discontinuations due to AEs have occurred.
- Further anti-tumor activities have been observed with longer follow-up. As of the data cut-off date of January 10, 2025, there were two unconfirmed responses and one confirmed response as defined by RECIST v1.1 in Cohort 2.
The patient who experienced a confirmed objective response has been in response for 17 weeks and remains in the study. This patient received the first two [212Pb]VMT-α-NET doses at administered dose of 5.0 mCi (equivalent to 84.6 µCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 µCi/kg) due to an adverse event that was determined by the investigator to be unrelated to [212Pb]VMT-α-NET.
One patient was observed to experience an initial (unconfirmed) response in the fifth scan after their first dose, which was the first scan conducted after the end of their treatment period. This patient experienced gradual tumor regression throughout the study, with the magnitude of change meeting the criteria for response on their most recent scan. This patient received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg) of [212Pb]VMT-α-NET.
A third patient was observed to experience an initial (unconfirmed) response in the seventh scan after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 31.7 µCi/kg) of [212Pb]VMT-α-NET. Gradual tumor regression was first observed in the fifth scan after their first dose, with the magnitude of change meeting the criteria for response on their most recent scan.
Five patients continue to have stable disease. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.
As stated in our August 12, 2024 business update for the second quarter of 2024, the observation period was completed for dose limiting toxicity (DLT) in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the Safety Monitoring Committee (SMC) determined that safety observations during the DLT period supported proceeding with dose escalation to Cohort 3 and increasing the number of patients dosed at 5 mCi (up to 40 more patients).
- Based on FDA interactions prior to the initiation of patient dosing in this study, which occurred in November 2023, the decision to open Cohort 3 will follow consultation and alignment with the agency. Once we have alignment, we will communicate to stakeholders regarding how the study will proceed. In December 2024, we submitted data from 2 patients in Cohort 1 and seven patients from Cohort 2 to the FDA.
- As previously announced, since Cohort 2 reopened for enrollment in August 2024 and through year end 2024, an additional 11 patients have been dosed. A total of 18 patients have been dosed in Cohort 2 as of December 31, 2024.
"I am excited to see a signal of deepening of anti-tumor activity for [212Pb]VMT-α-NET at the dose level used in Cohort 2 with longer follow-up, while [212Pb]VMT-α-NET remains well-tolerated," said Richard L. Wahl, MD, Professor of Radiology, Mallinckrodt Institute of Radiology at Washington University School of Medicine. “I look forward to sharing these results with a broader physician community at ASCO-GI and participating in the continuation of this study.”
Markus Puhlmann, Chief Medical Officer of Perspective, commented, “The dose finding study for [212Pb]VMT-α-NET is progressing well, with robust participation in the re-opened Cohort 2. In keeping with the commitment we made to the FDA prior to the start of dosing in this study, we commenced engagement with the FDA to pursue dose escalation while continuing to enroll patients into Cohort 2. An update will be provided once alignment is reached with the agency.”
Thijs Spoor, Chief Executive Officer of Perspective, commented, “As we continue to advance as a clinical-stage oncology company, we will be able to apply learnings from our lead clinical programs to new programs and potential new medicines based on our next generation targeted radiopharmaceutical technology platform. Meanwhile, in-sourcing clinical operations and other functions allows us to execute better and share clinical updates regularly with key stakeholders. We look forward to making progress in advancing our clinical pipeline and supporting infrastructure to serve more patients.”
Perspective will webcast a conference call on Friday, January 24, 2025 at 8:00 am ET to discuss the data to be presented at the ASCO-GI symposium. Webcast details are available on the Events page of the Company's website. The lead investigator of the study, Richard L. Wahl, MD (Professor of Radiology, Mallinckrodt Institute of Radiology at Washington University School of Medicine) will participate, along with members of Perspective's management team. A live question and answer session will follow the formal presentation.
About VMT-α-NET
VMT-α-NET is a clinical-stage, targeted alpha-particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of patients with somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors (NETs), which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective's proprietary lead-specific chelator (PSC) to bind 203Pb for SPECT imaging, and 212Pb for alpha-particle therapy. Perspective is conducting a multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapies (RPT). Perspective received Fast Track Designation for this program from the U.S. Food and Drug Administration (FDA) based on preclinical data for SSTR2-positive NETs regardless of prior treatment response. Perspective is also collaborating with a number of thought leaders to further elucidate the clinical profile of [212Pb]VMT-α-NET through investigator-initiated studies in the U.S. as well as overseas.
About Neuroendocrine Tumors
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are over 170,000 people living with this diagnosis.1
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moeities. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moeities which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations.
For more information, please visit the Company's website at www.perspectivetherapeutics.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential," or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s ability to pioneer advanced treatment applications for cancers throughout the body; the Company’s ability to make progress in developing treatments for neuroendocrine tumors; the Company’s anticipated timing and expectations regarding regulatory communications, requests, interactions, submissions, alignment, and approvals; the Company’s activities and plans to pursue dose escalation and enrollment in a third cohort for its Phase 1/2a clinical trial of [212Pb]VMT-α-NET; the Company’s expected timing for the receipt and disclosure of additional data regarding the Company’s Phase 1/2a clinical trial of [212Pb]VMT-α-NET; the Company’s ability to apply learnings from its lead clinical programs to new programs and potential new medicines based on the Company’s targeted radiopharmaceutical technology platform; the potential benefits of the Company in-sourcing clinical operations and other functions; the Company’s ability to make progress in advancing its clinical pipeline and supporting infrastructure to serve more patients; the Company’s ability to provide targeted and effective treatment options for cancer patients; the ability of the Company’s proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides; the Company’s prediction that complementary imaging diagnostics that incorporate certain targeting peptides provide the opportunity to personalize treatment and optimize patient outcomes; the Company’s belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company’s ability to develop a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations; the Company’s clinical development plans and the expected timing thereof; the expected timing for availability and release of data in connection with its clinical trials; expectations regarding the potential market opportunities for the Company’s product candidates; the potential functionality, capabilities, and benefits of the Company’s product candidates and the potential application of these product candidates for other disease indications; the Company’s expectations, beliefs, intentions, and strategies regarding the future; the Company’s intentions to improve important aspects of care in cancer treatment; and other statements that are not historical fact.
The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Media and Investor Relations Contacts:
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Nic Johnson
1 Wu P, He D, Chang H, Zhang X. Epidemiologic trends of and factors associated with overall survival in patients with neuroendocrine tumors over the last two decades in the USA. Endocr Connect. 2023;12(12):e230331. Published 2023 Nov 23. doi:10.1530/EC-23-0331
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