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Clinical Development

Emerging Trends in Radiopharmaceuticals

  • September 20, 2023

Medical Radiation Experts Share Highlights from TRP 2023 

In July 2023, Medpace radiopharmaceutical experts attended the Annual Targeted Radiopharmaceuticals Summit US (TRP) in Boston, MA. Learn more from Senior Medical Director and Radiation Oncologist, Dr. Jess Guarnaschelli, and Clinical Trial Manager, Dr. Stephanie Millin, as they recap highlights from the conference.  

Emerging Trends in Radiopharmaceuticals – TRP US 2023

Radiopharmaceuticals show a lot of promise in the clinical space following the approvals of Xofigo,  Lutathera and Pluvicto, with numerous further compounds in development showing great potential to diagnose and treat a wide variety of malignancies. However, challenges remain to ensure these unique molecules remain at the forefront of medical advancement; TRP 2023 incorporated a wide variety of topics addressing these various hurdles but at the forefront were supply chain management and methods to maximize the efficacy of approved and developmental compounds. Other topics included radiobiology, dosimetry, and extrapolating historic, academic literature and concepts from external beam radiation oncology.  

Supply Chain Advancements

The short half-life of radiopharmaceutical products presents ongoing challenges for upscale and widespread use, especially for therapeutic products which are often manufactured at a central location for global distribution. Multiple steps in the manufacturing process must be coordinated in a ‘just-in-time’ manner to produce the final product. Supply chain issues with Lutathera and Pluvicto, which resulted in the manufacturer temporarily halting supply, demonstrate how even established supply chains can fail. This has an impact not only on patient care, but on physician’s confidence in offering these treatments to their patients and ultimately future market value of the product and wider radiopharmaceutical industry. Kevin Haehl (Nucleus Radiopharma, CDMO) highlighted the importance of planning for redundancy at multiple points of failure to avoid supply interruptions. Plans for upscaling manufacturing need to occur at an earlier timepoint than more ‘traditional’ drugs to allow time for infrastructure development and ensure supply continues to meet demand as it expands. Long-term planning and investment are critical to the success of these novel therapies.   

Exploring New Radioisotopes

With limitations on the production of certain alpha emitting isotopes, biopharma companies are beginning to explore alternative radioisotopes such as 211At,  223Radium, and 212Lead which offer interesting opportunities for both imaging and therapy. With that comes the need for further supply chain development but also methodological enhancement. We are seeing exciting developments in the field of dosimetry to keep up with the rapid expansion to different radioisotopes and corresponding dosimetric requirements. Normal organ dose limits were a recurring topic, inciting discussions on whether the traditional limits derived from External Beam Radiation Therapy (EBRT) are truly representative of toxicity and how more appropriate parameters should perhaps be developed specifically for the modality of targeted radiopharmaceuticals.  

Optimizing Efficacy in Radiopharmaceuticals

Modern cancer treatments are rarely administered as monotherapies and more often as a combination of two or more agents. Another recurring theme at TRP US 2023 was how this could be and is being applied to the field of radiopharmaceuticals. Discussions included the use of radiopharmaceuticals with a vast array of other agents including immunotherapies, chemotherapeutics, radiosensitizers, and radioprotectors. This is already showing promise with several ongoing trials of approved and developmental radiopharmaceuticals. 

Combination Therapies with Alpha Emitters

Another TRP discussion overlapped between external beam radiation and radiopharmaceutical therapy. Specifically, the therapeutic index was covered in comparison between external beam radiation and radioligands. They covered many different solid tumors and drugs used concurrently with external beam. Solid tumors discussed included lung cancers, rectal, anal, cervical, esophageal, and glioblastoma. The last drug approved combination with external beam radiation was Cetuximab in 2006. Erbitux is an epidermal growth factor antagonist indicated for the treatment of head and neck cancer in combination with radiation therapy.  

The many DNA damage response pathways were reviewed (base excision repair, nucleotide excision repair, mismatch repair, homologous repair, and non-homologous repair). Following this, a discussion was had in regard to immuno-oncology combinations used with radioligand therapy. There are potential future combinations using differing isotopes and also isotopes used in combination with EBRT. 

Upcoming Webinar

Interested in learning more? Register for our upcoming webinar, “The Forefront of Radiopharmaceutical” today.

An Industry Leader in Radiopharmaceutical Clinical Research

Medpace offers seamless partnerships and collaborations with many radiopharmaceutical and radiation oncology device companies. We welcome Phase 1 through Phase 3 radiopharmaceutical, radiosensitizer, radioprotector, and device trials.  

We welcome the opportunity to talk about your upcoming clinical development in radiopharmaceuticals.  Contact our radiation experts today.