CLARINET FORTE is a prospective single-arm, open-label, exploratory, international Phase II study to explore the efficacy and safety of an increased Somatuline® Autogel® (lanreotide) dosing interval (120 mg every 14 days) in patients with metastatic or locally advanced unresectable pancreatic NETs or midgut NETs, with centrally-accessed progression within the last two years while on a standard lanreotide regimen (120 mg every 28 days) for more than 24 weeks.
Data announced in September 2020 at the 2020 European Society for Medical Oncology (ESMO), indicated the phase 2 results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatments. This means patients with progressive NETs are able to remain on a more tolerable first-line standard of care for longer,” said Professor Marianne Pavel, Friedrich-Alexander University of Erlangen, Germany, Senior Physician and Chair of Endocrinology, and lead investigator of the study. Headline points:
- Increasing the dose frequency of Lanreotide from monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NET.
- These results show no new safety signals associated with this increased dose regimen, potentially delaying the need for additional, more toxic second-line therapies.
Interesting output because I know that some patients are already on increased dosing to counter the effects of syndromes and this data underscores the anti-tumour effects of Lanreotide and perhaps gives those already on increased dosing an unintended benefit from an anti-tumour perspective. It means a further period without the need to go onto more toxic treatments such as Afinitor (Everolimus), Sutent (Sunitinib)(for PanNETs), PRRT or even Chemotherapy in some scenarios. The trial took place at 32 locations across Europe.
To see a comparison of the main somatostatin analogues (Lanreotide and Octreotide) please also read here.
CLARINET FORTE Clinical Trial document. This can be found here and is marked complete at July 2020.
See below a video clip from Dr Marianne Pavel, current Chair of ENETS.
Disclaimer. Ronny Allan has received no financial payment from Ipsen for producing this post and the content does not constitute a recommendation to use any of their products.
Disclaimer: Taking part in a clinical trial is a big decision and must be considered carefully in conjunction with your healthcare professionals and close family. Mention of any clinical trial on RonnyAllan.NET is not a recommendation to participate.
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