How ready are we for radioligand therapies?  

Cancer cells

DDW Editor Reece Armstrong speaks to Jasminka Taleska, Director, RLT HCS Readiness and Policy at Novartis, about the opportunities radioligand therapies (RLTs) represent in treating cancer patients.  

RA: What are the potentials of RLTs across cancer? 

JT: Cancer is an incredibly complex and heterogeneous disease, and, devastatingly, around 10 million people worldwide lose their lives to it every year1 

Despite the progress made in care, there remains a significant gap in treatment options for people with rare cancers and those that are resistant to standard therapies. The challenge lies in finding treatments that balance efficacy and quality of life (QoL) as many treatments may affect healthy cells in addition to cancerous cells, which at times leaves patients with severe side effects2,3,4. 

Radioligand therapy (RLT) represents an innovative approach to cancer care, finding and treating cancer cells, wherever they are in the body2,5. Its unique mechanism of action aims to deliver treatment directly to cancer cells, minimising damage to nearby healthy cells2,5. Currently, Novartis has launched the first RLTs for neuroendocrine tumors and post-taxane metastatic castration-resistant prostate cancer (mCRPC)2. Novartis is also investigating RLT in earlier lines and other types of cancers, including breast, lung, colon, pancreatic and glioblastoma. 

RA: What are some of the major barriers for access to RLTs?  

JT: There is a clear need to tackle the major barriers within healthcare systems (HCSs) so that they, and patients, can benefit from innovations6,7. Such barriers impacting access to RLTs include: 

Diagnostic capacity: Personnel shortages and inconsistent access to RLT diagnostic equipment, such as PET scans, lead to waitlists and scheduling challenges. Enhancing the visibility and access of funding options for RLT diagnostic equipment and hospital facilities can help overcome access barriers across Europe8,9. 

Patient referral: The lack of standard referral pathways in Europe complicates the onboarding of new RLT centers, particularly those with limited experience. Standardised referral guidelines are necessary to ensure consistent care across European Member States, emphasising the involvement of multidisciplinary teams for efficient diagnosis and treatment8,9. 

Centres: Many facilities in Europe lack trained staff, protective gear, lead-protected rooms, updated imaging and proper radioactive waste disposal procedures. Sufficient funding is needed to enhance these facilities by investing in specific infrastructure for nuclear medicine referrals and services, as well as technical equipment and trained workforce8,9. 

Release frameworks: The varying safety and handling protocols for radioactive material across Europe results in increased costs and limited availability of personnel. Adjusting existing regulatory frameworks to establish radiopharmaceuticals as a distinct category of medicinal products would facilitate the development of safe administration pathways8,9. 

Workforce training: The insufficient number of personnel trained to administer RLT hinders treatment availability across Europe, so there is a need to develop a harmonized training curriculum and enhance medical training across Member States. This can be supported by funding programs like the EU4Health Program and European Reference Networks8,9 

RA: Do these barriers restrict or hinder the uptake of drug discovery research into RLTs? Or is it the opposite – where innovation is soaring, but healthcare readiness is lacking?  

JT: HCS readiness and capacity for appropriate and equitable use of this treatment modality across Europe is lagging behind the innovation. Without the necessary infrastructure, resources and policies in place, the potential benefits of RLT may not be fully realised6 

Investing in innovation should be seen as a societal investment as it not only improves patient outcomes and productivity, but also enhances the efficiency and effectiveness in healthcare delivery, generating cost savings and helping to create more resilient, future-ready HCSs6,7. 

RA: How crucial is it that healthcare institutions have the diagnostic capabilities to identify applicable patients for RLTs?  

JT: Currently across Europe, there is low overall RLT diagnostic capacity and varying access to diagnostic tools, but it’s extremely important for healthcare institutions to have these capabilities to be able to identify eligible patients for treatment6. By increasing access and funding to these resources, including PET/CT and SPECT/-CT scanners, we can ensure patients receive personalised and targeted treatment plans, which maximise the chances of successful outcomes6. 

RA: In terms of RLT delivery, is infrastructure (nuclear medicine department) and training a concern across the healthcare sector?  

JT: Training healthcare workers is crucial to grow the workforce and ensure safe administration of RLTs6,10,11. However, there are currently gaps in education, and training pathways lack alignment across countries6,10,12. To address these challenges, we have partnered with European Association of Nuclear Medicine (EANM), the International Atomic Energy Agency (IAEA) and other academia and medical society partners to develop the RLT Academy13. The initiative aims to address these gaps by equipping medical professionals with the necessary knowledge and skills to effectively utilise RLT in practice. In addition to providing educational resources, the RLT Academy will provide recommendations for policy changes related to RLTs in Europe. It’s important to mention that the European funding received through the Erasmus+ grant has played an important role in making the academy possible. It is the result of a two-year multistakeholder collaboration. 

In terms of infrastructure, without making the needed changes, the promise of RLT in cancer can’t be fully realised. The discussions we are having are critical in driving these changes so that every eligible patient can benefit from RLT, no matter where they are in the world.  

RA: On the topic of training, what are your thoughts on the RLT Academy launch in Europe 

JT: The RLT Academy launch is a great example of a meaningful collaboration between key stakeholders and EU parliament. It is a transnational education program for healthcare professionals (HCPs) to tackle one of the most critical HCS readiness pillars, workforce training6,10,13. The primary goal of the RLT Academy is to address existing educational gaps in Europe and support the adoption of RLTs by the medical community. It offers a comprehensive range of educational resources, including multidisciplinary online training, knowledge repositories and opportunities for hands-on fellowships. By providing enhanced education, the aim is to bridge the capacity gap and empower HCPs to establish and expand RLT services in their practices. As a representative of Novartis, I am proud to be a part of this initiative, and I believe it could have a transformational impact on the lives of thousands of cancer patients.  

RA: Novartis is heavily invested in this treatment area. What potential do RLTs have across cancer indications  

JT: The application of RLT in cancer is endless and Novartis is actively investigating its potential. Novartis has two RLTs approved for use, one for post-taxane metastatic castration-resistant prostate cancer (mCRPC) and one for gastroenteropancreatic neuroendocrine tumors (GEP-NETs)2,14,15, and continues to investigate these treatments in earlier lines, in addition to exploring a broad portfolio of RLTs in other cancers, including breast, colon, lung and pancreatic.  

As of 2023, we have 10 radioligand assets in clinical development and over 15 clinical studies in Phases I to III. We also have a number of candidates in preclinical development to investigate the treatment potential of RLTs.  

RA: How welcome are working sessions, such as the recent one hosted by MEP Niels Geuking, in helping address barriers to RLT delivery and access? 

JT: Initiatives, such as the working session hosted by Niels Geuking, are vital to improving access to RLTs to patients around Europe. The collaboration and working sessions allow important topics to be brought to the political agenda that could help to support HCS readiness. By working collaboratively, we can strive to make RLT scalable and accessible to patients worldwide. The working session provided an opportunity to engage in discussions and develop strategies that will ultimately benefit patients and enhance readiness for RLT implementation.  

RA: How important is a consistent regulatory framework across Europe for RLTs (i.e., radioligands are viewed as therapies in some countries vs radioactive substances in others, or how radioisotopes differ between their diagnostic and therapeutic purposes)? 

JT: This is very important6. Currently, RLT remains poorly recognised in policy frameworks, such as cancer control plans, so there is work to be done to create common understanding and commitment around how to use this innovation in appropriate settings6 

From a regulatory standpoint, there is significant heterogeneity and discrepancies amongst countries regarding radioprotection and safety regulations6. Despite the existence of initiatives like the EU’s Euratom Treaty and the SAMIRA Action Plan, there is need for harmonisation16,17,18. 

To address this challenge, one solution would be to establish RLT as its own class of medicine. This would provide a dedicated and standardised approach to RLT regulation, while ensuring consistency and safety across European countries.   

RA: What is Novartis doing to support the uptake of RLTs in Europe? 

JT: Novartis supports the uptake of RLTs in Europe by driving HCS readiness through collaborations that bring RLT to the political agenda, addressing gaps in knowledge and skills and collaborating on policy framework for RLT integration. Support extends throughout the European region, highlighting Novartis dedication to drive advancements in RLT implementation and integration. 

In addition to collaborations on the RLT Academy and the IQVIA Institute on the policy framework, Novartis is actively supporting the uptake of RLTs through various initiatives, including:  

  • INSPIRE initiative on workforce from EANM, which aims to meaningfully improve mid- to long-term workforce recruitment for nuclear medicine. We are collaborating on a multifaceted framework that raises awareness about nuclear medicine and its contribution to patient outcomes and offers work experiences and incentives for medical students to pursue a career in nuclear medicine. By fostering interest and engagement in this field, we strive to address the workforce shortage and ensure a sustainable and skilled workforce for the future. 
  • Patient organisations and HCPs on SPARC Europe, a framework-building initiative to bring RLTs to patients18. 

Biography

With over two decades of experience in the pharmaceutical industry, Dr. Jasminka Taleska has emerged as a strategic leader in healthcare system (HCS) readiness and shaping health policy. Her expertise in radioligand therapy has significantly increased global patient access and improved health outcomes. She is passionate about creating meaningful change in HCS and looks forward to new opportunities to drive innovation through policy and partnerships to transform patients’ lives worldwide.

References 

1: World Health Organization (WHO). Global cancer burden growing, amidst mounting need for services. February 1, 2024. Accessed April 12, 2024. https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services 

2: Aboagye EO, Barwick TD, Haberkorn U. Radiotheranostics in oncology: Making precision medicine possible. CA Cancer J Clin. 2023;73(3):255-274. doi:10.3322/caac.2176 

3: Botta L, Dal Maso L, Guzzinati S, et al. Changes in life expectancy for cancer patients over time since diagnosis. J Adv Res. 2019;20:153-159. doi:10.1016/j.jare.2019.07.002  

4: Lewandowska A, Rudzki G, Lewandowski T, et al. Quality of Life of Cancer Patients Treated with Chemotherapy. Int J Environ Res Public Health. 2020;17(19):6938. Published 2020 Sep 23. doi:10.3390/ijerph17196938 

5: Duan H, Iagaru A, Aparici CM. Radiotheranostics – Precision Medicine in Nuclear Medicine and Molecular Imaging. Nanotheranostics. 2022;6(1):103-117. doi:10.7150/ntno.64141  

6: Merkel C, Whicher CH, Bomanji J, et al. Realising the potential of radioligand therapy: policy solutions for the barriers to implementation across Europe. Eur J Nucl Med Mol Imaging. 2020;47(6):1335-1339. doi:10.1007/s00259-020-04745-7 

7: Health System Readiness. What is health system readiness? Accessed July 17, 2023. https://www.healthsystemreadiness.com/ 

8: IQVIA. Succeeding with Innovation: The State of Radioligand Therapy Readiness in Europe. IQVIA Instititue for Human Data Science. December 2023. Accessed March 14, 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/succeeding-with-innovation-state-of-radioligand-therapy 

9: IQVIA on file. Pathway to Success in Cancer Treatment: Achieving Radioligand Capacity and Readiness in Europe – A Public Working Session 

10: Calais J, Eulau SM, Gardner L, et al. Incorporating radioligand therapy in clinical practice in the United States for patients with prostate cancer. Cancer Treat Rev. 2023;115:102524. 

11: Bugani V, Battistelli L, Sansovini M, et al. Radioligand therapies in cancer: mapping the educational landscape in Europe [published online ahead of print, 2023 Apr 14]. Eur J Nucl Med Mol Imaging. 2023;1-7. 

12: Bly R. Radiation safety of current European practices of therapeutic nuclear medicine: survey results from 20 HERCA countries. J Radiol Prot. 2023;43(1):10. 

13: European Association of Nuclear Medicine (EANM). Radioligand Therapy (RLT) Academy. Accessed April 22, 2024. https://www.eanm.org/advocacy/eu-related-activities/radioligand-therapy-rlt-academy/ 

14: Pluvicto. Summary of Product Characteristics. Novartis. 2022. Accessed October 30, 2023. https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf 

15: Lutathera. Summary of Product Characteristics. Advanced Accelerator Applications. 2018. Accessed October 30, 2023. hhttps://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf 

16: European Commission. SAMIRA Action Plan. Accessed June 21, 2023. https://energy.ec.europa.eu/topics/nuclear-energy/radiological-and-nuclear-technology-health/samira-action-plan_en 

17: EurLex Europa. Treaty on the European Atomic Energy Community (Euratom). Updated May 25, 2018. Accessed April 22, 2024. https://eur-lex.europa.eu/EN/legal-content/summary/treaty-on-the-european-atomic-energy-community-euratom.html 

18: Stakeholder Political Alliance for Radioligand Cancer Therapies (SPARC) Europe. Investment Pathway. Guide for the delivery of radioligand cancer therapies. February 2022. Accessed October 31, 2023. https://www.europeancancer.org/index.php?option=com_attachments&task=download&id=1018:SPARC-Europe_Pathway_Radioligand_Cancer_Therapies_FINAL_February 

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