Perspective Therapeutics, Inc. has announced initial results from its phase 1/2a study of [212pb]vmt01 at the 21st International Congress of the Society for Melanoma Research. The study is a multi-center, open-label dose escalation, dose expansion study in patients with histologically confirmed melanoma and mc1r-positive imaging scans.
In terms of safety findings, no dose-limiting toxicities were observed among any patients, and no adverse events led to treatment discontinuation. Treatment emergent adverse events were mostly grades 1 and 2, with no grade 4 or 5 events reported. No renal toxicities have been reported to date.
As for efficacy findings, all patients in cohort 1 completed three treatments, with one patient experiencing an objective response, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively. In cohort 2, patients progressed after either the first cycle (3 patients) or the second cycle (4 patients).
The Safety Monitoring Committee recommended exploring a lower dose level of 1.5 mCi per dose, which is lower than the dose administered in cohort 1, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The combination cohort at 1.5 mCi per dose with nivolumab is active and now open for enrollment.
Dr. Zachary Morris, lead investigator of the study, expressed optimism about the potential of a combined treatment approach involving [212pb]vmt01 with immune checkpoint inhibitors to extend the benefits of immunotherapy to a greater number of patients with metastatic melanoma.
The Chief Medical Officer of Perspective, Markus Puhlmann, commented on the safety observations from the study supporting the move ahead with the combination cohort with nivolumab, where encouraging additive effects of combining [212pb]vmt01 with immunotherapy treatments were seen in preclinical studies.
Thijs Spoor, CEO of Perspective, highlighted the observed efficacy at a low dose of radiation and emphasized the versatility of their proprietary alpha-emitter platform in enabling the development of potential new cancer therapies and the exploration of combinations with established treatments.
The company remains on track to provide an update this calendar year on the company-sponsored phase 1/2a study of vmt-α-net for unresectable or metastatic somatostatin receptor type 2-positive neuroendocrine tumors.
In September 2024, the U.S. Food and Drug Administration granted fast track designation for the development of [212pb]vmt01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated mc1r tumor expression.
Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, and metastatic melanoma has a poor prognosis with limited survival. Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body, utilizing the alpha-emitting isotope 212pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. As a result of these announcements, the company's shares have moved -13.3% on the market, and are now trading at a price of $11.49. Check out the company's full 8-K submission here.
