On September 12, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported the presentation of encouraging early clinical results from an open-label, single-arm, investigator-initiated study investigating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha therapy (TAT), in patients with metastatic neuroendocrine tumors (NETs) and medullary thyroid carcinomas (Press release, Perspective Therapeutics, SEP 12, 2023, View Source [SID1234635108]). The results were presented at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM), held in Vienna, Austria, from September 9-13, 2023.
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Highlights of the presented results include:
Ten patients who failed at least 1 prior line of standard of care therapy have received [212Pb]VMT-α-NET therapy to date, with initial responses observed in 7 of 9 evaluable patients. Responses were observed across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-refractory disease. Of the 10 patients enrolled in the study, 3 presented with gastrointestinal NETs, 5 presented with pancreatic NETs, and 2 presented with medullary thyroid carcinoma. Four patients (1 with gastro-intestinal NETs; 3 with pancreatic NETs) were previously treated with [177Lu]DOTATATE PRRT, one of which also received 3 prior administrations of [225Ac]DOTATATE.
Improvements in patients’ symptoms and quality of life trended strongly positive with consecutive [212Pb]VMT-α-NET doses.
No significant renal or hepatic function adverse events have been observed to date. Most adverse events were mild and included Grade 1 anemias, alopecia, and fatigue, which usually resolved within 1 week of [212Pb]VMT-α-NET administration. Two patients experienced serious adverse events (SAEs) that were deemed unrelated to [212Pb]VMT-α-NET treatment. One patient who developed myelodysplastic syndromes (MDS) discontinued treatment and the other patient, who was heavily pre-treated, died (patient was deemed not evaluable).
"We have safely administered a total of 25 doses of [212Pb]VMT-α-NET across the 10 patients enrolled in the trial, with two of these patients having received all 4 doses to date," commented Dr. Dharmender Malik, Consultant Nuclear Medicine and PET-CT, MBBS, DNB, FANMB & RSO-II, at the Fortis Memorial research institute (FMRI), Gurugram India. "[212Pb]VMT-α-NET shows encouraging initial efficacy and safety across different neuroendocrine and medullary thyroid tumor types in patients who failed prior lines of therapy, including standard of care [177Lu]DOTATATE, and [225Ac]DOTATATE."
"While still early, these initial high objective response rates are promising in light of the 13% response rate for LUTATHERA (www.novartis.com/us-en/sites/novartis_us/files/lutathera.pdf, Table 8). We are especially encouraged by the responses at low [212Pb]VMT-α-NET activity doses as these are in the starting range of our IND-enabled dose escalation study which is currently screening patients in the US," said Thijs Spoor, Chief Executive Officer at Perspective. "Additionally, these early responses among multiple tumor types suggest the potential to expand into other indications including small cell lung cancers, meningiomas, pheochromocytomas, paragangliomas, and neuroblastomas – especially given the compelling preclinical neuroblastoma [212Pb]VMT-α-NET therapy data presented at EANM on Sunday. We will continue to monitor patients’ progress, and we look forward to providing a more extensive data readout in the upcoming quarters."
About the study
Ten adult subjects with histologically confirmed NETs and metastatic medullary thyroid carcinomas who failed at least one prior line of treatment were treated as part of a compassionate use program. All patients were planned to receive [212Pb]VMT-α-NET peptide at intervals of 8 weeks up to 4 doses or until evidence of radiographic progression, unacceptable toxicity or the patient’s decision to discontinue. All patients were to be co-infused with an amino acid solution for renal protection. The primary objective of the study is to evaluate the safety of low doses of [212Pb]VMT-α-NET in this patient population. Secondary assessments will include objective response rate measured by RECIST 1.1 criteria, and the number of patients with treatment-related adverse events as assessed by CTCAE v.4.0. Both will be measured at 24 months after the last administered dose of [212Pb]VMT-α-NET. Isotope was provided using Perspective’s proprietary VMT-α-GEN generator.
About VMT-α-NET
VMT-α-NET is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing NETs. In early December 2022, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned U.S. trial.