VMT01 Earns FDA Fast Track Designation in MC1R-Positive Melanoma

Histologic image of skin cancer cells

• The FDA has granted fast track designation to ²¹²Pb VMT01 for the diagnosis and treatment of unresectable or metastatic melanoma with MC1R tumor expression.
• VMT01 is being investigated in a phase 1/2 study (NCT05655312).
• The agent is designed to target and deliver ²¹²Pb to tumor sites expressing MC1R.

VMT01 has been granted a fast track designation from the FDA for the treatment of MC1R-expressing unresectable or metastatic melanoma.¹

Fast track designation is intended to expedite the development and review of agents that treat serious conditions and fill unmet medical needs. With this designation, Perspective Therapeutics, the sponsor, can have more frequent interactions with the FDA, and the application of VMT01 may be eligible for accelerated approval, priority review, and rolling review.

“We are pleased with the FDA’s recognition of the need for additional treatment options for patients with metastatic melanoma,” said Markus Puhlmann, MD, chief medical officer of Perspective Therapeutics, in a press release. “We are dedicated to working closely with the agency to accelerate VMT01's clinical development. Having recently completed the observation period for dose limiting toxicity in 7 patients enrolled in cohort 2 of our phase 1/2a study, we look forward to sharing safety observations with the safety monitoring committee and in a scientific forum later this year. Additionally, pending institutional review board approval, we plan to open a VMT01/anti-PD-1 combination cohort.”

VMT01 is being investigated in a phase 1/2 study. The trial is currently recruiting across 9 locations in Florida, Iowa, Kentucky, Minnesota, Missouri, Nebraska, Pennsylvania, and Wisconsin. Currently, an estimated 52 patients are enrolled.₂

The study’s primary end points are incidence of treatment-related adverse effects, laboratory abnormalities, dose-limiting toxicities, and objective response rate. Secondary end points include pharmacokinetics, duration of response, progression-free survival, and overall survival.

In the dose-escalation portion of the study, patients are receiving intravenous (IV) ²⁰³Pb VMT01 as an imaging agent. Those who have positive uptake of ²⁰³Pb VMT01 then are being treated with a fixed dose of IV ²¹²PB VMT01 between 111 and 555 MBq every 8 weeks for up to 3 doses. In the dose-expansion portion, patients are receiving a fixed dose of IV ²¹²PB VMT01at the recommended phase 2 level and schedule every 8 weeks.

To be eligible for study enrollment, patients must have stage IV or unresectable stage III melanoma that has progressed on at least 1 prior line of treatment, an ECOG performance status of 2 or lower, a life expectancy of at least 3 months, and sufficient organ function. Those with an active secondary malignancy, active infection, or brain metastasis are not eligible for participation.

REFERENCES:

1. Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R-positive melanoma. News release. Perspective Therapeutics. September 5, 2024. Accessed September 9, 2024. https://tinyurl.com/mwpa5hu9

2. MC1R-targeted alpha-particle therapy trial in adults with advanced melanoma. ClinicalTrials.gov. Updated August 22, 2024. Accessed September 9, 2024. https://clinicaltrials.gov/study/NCT05655312