Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

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This trial drug was once owned by Ipsen but they decided to sell it off.  However, in Jun 2022, Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, announced the successful investment source of EURO 25 Million.  The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Satoreotide is a radiopharmaceutical drug and an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in many cancers, including certain hard-to-treat cancers such as small cell lung cancer (SCLC), high-grade neuroendocrine tumours (NETs) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children. Satoreotide will be used as a ‘theranostic’ for both the diagnosis and treatment of tumours expressing the SST2 receptor. Satoreotide is in early clinical development and, as of today, has been administered to more than 100 patients including more than 150 therapeutic administrations.  Those patients previously administered when Ipsen was the lead Pharma will now be followed up in a separate study and hopefully, the data will be shared with the new lead Pharma. 

The term antagonist is important, most PRRT in sue is agonist. The differences are quite technical but hopefully, I explained them below. 

added 31 Mar 2022. Click on picture to see follow up study

What is Lutetium-177 OPS-201? (note: any new trials may be given a new name)

This is a ‘next generation’ Peptide receptor radionuclide therapy (PRRT) or more specifically the radiopharmaceutical that binds to both activated and unactivated somatostatin receptors which are upregulated on these tumours. There is far higher binding via this mechanism than standard octreotate. The technical name of the radiopharmaceutical is Satoreotide tetraxetan lutetium-177 (author’s note, I’m guessing but it could be a variant of Lanreotide).  It was once named JR11.

What’s the difference between the currently approved therapy? 

Conventional PRRT (e.g. Lutathera, Lu177 Dotatate) is based on a somatostatin receptor ‘agonist’ approach, whereas 177Lu Ops 201 Satoreotide is a receptor ‘Antagonist’.  The differences are quite technical but in the most layman terms, the antagonist has the capability of attaching (binding) to more receptors, including those in a ‘resting’ or ‘inactive’ state, spends more time on the tumor than agonist-based therapies. The result is a higher number of receptor binding sites and greater tumor uptake.  In addition, it is said to show an improved tumor-to-kidney dose ratio compared to 177Lu-DOTA-TATE.

This would also be reflected in the theranostic use of the drug in Ga68 imaging (i.e. Ga68 Satoreotide).

Useful reading:

This presentation from Theranostics Australia

The Clinical Trial (NCT02592702) – now terminated

The clinical trial was named “Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPSC001 in NETs”.  The protocol involved 3 cycles 8 weeks apart of intravenous Lu-177 OPS-201. All patients had baseline Ga-68 octreotate imaging performed.

The therapy was available for all NET patients with a histologically confirmed diagnosis of:

  • unresectable GEP NET (Grade I and Grade II according to WHO classification (2010, Annex 01), functioning and non-functioning).
  • unresectable “typical lung NET” or “atypical lung NET” are acceptable (with the exception of Large Cell Bronchial Neuroendocrine Neoplasms and Small Cell Lung Cancers).
  • malignant, unresectable pheochromocytoma or paraganglioma

Patients who had previous Lu-177 octreotate (e.g. Lutathera) were not eligible. Patients may have had any other treatment including chemotherapy, radiotherapy or Somatostatin Analogues (e.g. octreotide, landreotide).

There were other inclusion and exclusion criteria to be found within the clinical trial document.  

Where was the Trial based?  

At the time of writing and according to the Clinical Trial document, Australia (Melbourne and Perth), Austria (Vienna), Canada (CHU de Quebec), Denmark (Aarhus), Switzerland (Basel), UK (Royal Free London).  Two sites were also listed in France (Nantes and Toulouse).  Two sites in USA (City of Hope California and MD Anderson Texas).  Another site in USA carried out a similar trial at MSK New York where the sponsors reported “In this trial of heavily treated NETs, preliminary data are promising for the use of 177Lu-satoreotide tetraxetan. Additional studies are ongoing to determine optimal therapeutic dose/schedule” – results posted here.

You may also find these PRRT related articles useful:

PRRT Overview plus locations 

Trial of Targeted Alpha-emitter Therapy (TAT) – 212 Pb-AR-RMX

COMPETE trial 177Lu Edotreotide-Solucin

 
 

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 

 
 

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