First Patient Dosed in Trial of [212Pb]VMT01 for Metastatic Melanoma

The first patient has been dosed with [212Pb]VMT01 — a targeted alpha-particle therapy — in a phase 1/2a trial evaluating the safety of the agent in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans, according to a news release from Perspective, Therapeutics, Inc.

In this cohort of patients, researchers are evaluating the investigative drug at 1.5 mCi in combination with the PD-1 blocking antibody Opdivo (nivolumab), whereas in earlier cohorts, patients received [212Pb]VMT01 as a monotherapy. The news release goes on to state that initial results from earlier cohorts of treatment with the monotherapy were presented in October of 2024 at the 21st International Congress of the Society for Melanoma Research.

Prior to the October 2024 presentation, the U.S. Food and Drug Administration granted fast track designation to the development of the targeted agent for the treatment of patients with unresectable or metastatic melanoma, according to a previous press release from the company. This means that the regulatory agency is allowing the agent to go through a process designed to facilitate the development of and expedite the review of [212Pb]VMT01, as it has the potential to fill an unmet medical need.

“The initial results from our phase 1/2a study of [212Pb]VMT01 are particularly encouraging for investigating this combination," Markus Puhlmann, chief medical officer of Perspective, commented in the news release. "The data presented at the Society for Melanoma Research highlight the promising safety profile of [212Pb]VMT01, with no dose-limiting toxicities observed, and early signs of anti-tumor activity in patients who have received multiple lines of prior treatment. These findings provide a strong foundation for further exploration of [212Pb]VMT01 in combination with immune checkpoint inhibitors, where we believe its dual mechanism of action can be harnessed to improve patient outcomes.”

More Information on the Investigative Therapy and Melanoma

Uncontrollable growth of melanocytes, which are the melanin producing cells of the body, is often what leads to a diagnosis of melanoma, a cancer of the skin. When melanoma is metastatic, this means the disease has progressed through multiple layers of the skin and infiltrated the blood stream or lymphatic system, thereby traveling to other areas of the body where it will then metastasize. Approximately 100,000 new diagnoses of melanoma occur annually in the United States, and there are about 8,300 annual deaths due to metastatic disease.

Without effective treatment, only half of patients with metastatic disease survive for one year, and long-term survival rates range from approximately 29% to 35% at five years. While new treatments have improved survival for some patients, there is still a significant need for additional options, especially for those whose cancer continues to grow despite initial therapy. Many second-line and later treatments, including the current standard of care, can slow the disease for a short period, with most patients experiencing cancer progression within two to five months.

It is because of these statistics that investigators are evaluating treatment with [212Pb]VMT01. The agent is designed to target cancer cells that produce MC1R, which is often found in these tumors, and deliver a radioactive particle directly to the cancer cells to help destroy them. 

“The data from this next part of the study will enable us to further develop our understanding of how lower-dose radiopharmaceuticals can be optimized in combination with immunotherapies,” Thijs Spoor, CEO of Perspective, concluded in the news release, adding that, “We are hopeful that this approach will enhance patient outcomes by improving both safety and efficacy, particularly for those with limited treatment options.”

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