The 50th ESMO Congress in Berlin highlighted significant advancements in radiopharmaceuticals, particularly from Perspective Therapeutics. The company showcased its image-guided, targeted alpha-particle therapies (TATs) that deliver the alpha-emitting isotope lead-212 (212Pb) directly to tumours. These therapies are paired with imaging agents to personalize treatment, a concept referred to as “theranostics.”
In 2025, Perspective Therapeutics achieved notable milestones, including the release of new interim data and the successful navigation of regulatory challenges regarding kidney dose limits in its neuroendocrine tumours (NETs) programme. The focus of this article is to explore these developments and their implications for oncology in the coming years.
Breakthroughs in Neuroendocrine Tumour Treatments
Neuroendocrine tumours arise in hormone-secreting glands throughout the body, often leading to a variety of symptoms that can severely impact a patient’s quality of life. Thijs Spoor, president and CEO of Perspective Therapeutics, described the patient experience at ESMO, highlighting symptoms such as flushing, diarrhoea, and general malaise. While patients can often be stabilised for years with somatostatin analogues, disease progression eventually necessitates more aggressive treatment options.
The somatostatin receptor subtype 2 (SSTR2) is commonly overexpressed in NETs, making it an ideal target for both imaging and therapy. Spoor emphasized that maintaining quality of life and systemic health is crucial, especially for patients who may live with the disease for decades. This reality establishes high expectations for both safety and efficacy in treatment options, particularly for potent alpha emitters like 212Pb.
Perspective Therapeutics employs a sophisticated approach that integrates image-guided dosimetry and biodistribution optimization. The company iterates compounds in animal models to minimize off-target organ retention, particularly in the kidneys and liver, and validates efficacy in preclinical studies. Following this, they conduct imaging in human subjects over a 24-hour period to predict tissue exposure before treatment begins.
One of the key clinical trials underway is a multi-centre, open-label Phase 1/2a dose-escalation/expansion trial of [212Pb]VMT-α-NET for patients with unresectable or metastatic SSTR2-positive NETs (NCT05636618). Spoor mentioned at the recent ASCO 2025 conference that the study indicated an impressive 57% response rate among participants, a figure that has generated excitement within the medical community regarding the potential of alpha therapies to surpass previous beta-based therapies, such as Lutathera (Lu-177-DOTATATE), which historically has around a 13% overall response rate.
Regulatory Advances and Future Prospects
A significant regulatory achievement this year involved the FDA’s approval to increase renal doses to 6 mCi, a development Spoor described as breaking a “concrete ceiling” within the radiopharmaceutical field. This decision stemmed from advancements in clinical imaging and dosimetry, and it marks a pivotal moment for the integration of radiopharmaceuticals in oncology treatments.
Spoor addressed the evolving landscape of oncology during his remarks at ESMO, framing the FDA’s 2025 draft guidance on oncology therapeutic radiopharmaceuticals as a complementary pathway to the EMA’s 2024 concept paper. While there are differences in expectations regarding long-term safety follow-up and trial design details, both regulatory bodies are laying the groundwork for a safer and more effective future in cancer treatment.
Looking ahead, Spoor envisions radiopharmaceuticals as a cornerstone of oncology alongside targeted chemotherapy and immuno-oncology therapies. He argues that the ability to combine targeted radiation with other modalities presents a new frontier in precision medicine. “Anything we can throw at cancer, we should,” Spoor concluded, highlighting the potential for a multifaceted approach that enhances treatment efficacy while minimizing toxicity.
As the oncology community anticipates further advancements, the next five years may see a significant increase in centres capable of delivering 212Pb therapies and clearer regulatory guidance. If the current momentum continues, radiotherapeutics could establish themselves as a primary pillar in oncology, expanding patient choices and raising the standards for treatment precision, safety, and long-term disease control.
With the combination of maturing safety data, promising efficacy signals, and regulatory support, Perspective Therapeutics is poised to play a key role in the evolution of cancer treatment, embodying the transformative potential of targeted alpha radiotherapeutics.
