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 frequency (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.
In a report from ENETS 2021 in late February 2021, Ipsen reported new data as follows:
Updated data from the CLARINET FORTE study were presented including additional quality of life (QoL) data showcasing assessments of patients’ perceived QoL during the treatment period of the study.1 QoL was assessed using three validated questionnaires covering the severity of problems associated with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L), as well as questionnaires specific to patients with cancer (EORTC QLQ-C30) and NETs (QLQ‑GINET.21). Results from these measurements suggest no deterioration of QoL with no substantial deviation from baseline prior to treatment. Additional pharmacokinetic (PK) analyses of the increased dosing regimen showed that PK increased in a proportional manner and no increase in rates of glycoregulation, cholelithiasis or hypertension in patients with increased lanreotide autogel exposure was observed. With confirmation of the PK data together with the substantial period of QoL preservation, data from the CLARINET FORTE study could represent a potentially meaningful treatment option for a population of patients with high unmet needs.
“The new findings from the CLARINET FORTE trial highlighted that QoL remained stable throughout the study in patients who were enrolled with progressive disease and who were receiving twice the frequency of injections compared with their pre-study regimen”, said Professor Marianne Pavel, Friedrich-Alexander University of Erlangen, Germany, Senior Physician and Chair of Endocrinology, and principal investigator of the study. “This is an important new measure as it reflects the patients’ perceptions of their own current overall health and means that patients with progressive NETs may be able to remain on a more tolerable first-line standard of care for longer with no new safety signals or quality of life deterioration.”
The following references were used:
1. Pavel et al., ENETS 2021. Efficacy, Safety and Quality of Life (QoL) with Lanreotide Autogel (LAN) 120 mg Every 14 Days in Progressive Pancreatic or Midgut Neuroendocrine Tumours (NETs): CLARINET FORTE Study Results.
2. Dehez et al., ENETS 2021. CLARINET FORTE: Characterization of Pharmacokinetics (PK), Efficacy and Safety in Patients with Progressive Neuroendocrine Tumors (NETs) Treated with Lanreotide Autogel (LAN) 120 mg Every 14 Days (q14d).
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 my own experience of Lanreotide – read here.
Read my 10-year Lanreotide anniversary here.
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.
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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Whenever I get a chance to talk to a pharma involved in somatostatin analogue injection devices, I tell them one very important thing …… “To