Date: 2013-06-17
Type of information:
phase: 3b
Announcement: presentation of results at the Endocrine Society1 annual congress (ENDO Congress, San Francisco, USAOral presentation: OR27-3 High Dose Lanreotide Autogel Treatment Produces Early and Sustained Reductions in Tumor Volume and GH/IGF-1 Levels in Treatment-Naïve Acromegalic Patients with GHSecreting Pituitary Macroadenoma: The PRIMARYS Study
Featured poster presentation: FP27-1 Potential Predictors of Macroadenoma Volume Reduction After Primary Therapy With Lanreotide Autogel in a Large Treatment-Naïve Acromegalic Population
Company: Ipsen (France)
Product: Somatuline® Autogel® (lanreotide) 120mg
Action mechanism:
Disease: newly diagnosed acromegaly patients with a macroadenoma
Therapeutic area: Rare diseases - Hormonal diseases - Endocrine diseases
Country:
Trial
details: PRIMARYS (PRIMARY treatment in macroadenoma acromegaly with Somatuline®) is a unique, open label, 1-year study, evaluating an investigational use of Somatuline® Autogel® 120mg (lanreotide) in 90 patients with newly diagnosed acromegaly. Spanning 9 countries worldwide, it is the only somatostatin analogue study assessing tumor volume reduction as a primary endpoint and with a rigorous central reading methodology involving 3 neuroradiologists.Somatuline® Autogel® 120mg was initiated in patients with macroadenoma, with one injection every 4 weeks and patients tumor volume assessment every 12 weeks (using MRI), GH, IGF-1, clinical symptoms, biochemical parameters, quality of life and safety over a total period of 48 weeks. In the Intention To Treat (ITT) population, the proportion of patients achieving ?20% tumor volume reduction from baseline to week 48 was 63% (95% CI, 52%-73%), according to the neuroradiologist with the highest repeatability and lowest intra-variability (primary analysis), and from 72% (95% CI, 61-81%) to 75% (95% CI, 65-84%) according to two other readers for whom CIs for the proportion of patients with tumour response was above the protocol predefined arbitrary 55% threshold.
Latest
news: * On June 17, 2013, Ipsen has announced the results of an international phase IIIB study, PRIMARYS, assessing an investigational use of Somatuline® Autogel® (lanreotide) 120mg as first line therapy in newly diagnosed acromegaly patients with a macroadenoma. While PRIMARYS did not meet statistical significance with respect to its primary efficacy endpoint, investigators observed clinically relevant tumor volume reductions, in a majority of patients. Data from secondary biomarker endpoints of growth hormone (GH) and insulin-likegrowth factor-1 (IGF-1) levels were further supportive of these findings. Baseline GH level was themain factor identified as potential predictor for tumor response to primary therapy.PRIMARYS is the first study of a somatostatin analogue in such a large and homogeneous population (90 treatment-naïve acromegalic patients with macroadenoma) to evaluate tumor volume reduction as the primary endpoint using Magnetic Resonance Imaging (MRI) with a very robust and unique methodology for central assessment.Pr John S. Bevan, co-Principal Investigator of the study, Head of Endocrinology at Aberdeen Royal Infirmary and Honorary Professor of Endocrinology at Aberdeen University (UK) said: “The results not only show a clinically relevant effect on the volume of the macroadenoma but are also very convincing for GH and IGF-1 lowering and improvement in clinical symptoms. Interestingly, all these beneficial effects can be observed after only 3 injections of Somatuline® Autogel® 120mg. The overall safety profile observed during this one year study was consistent with the safety profile of Somatuline® in acromegalic patients – despite the high doses administered, no patient had to stop treatment due to gastro-intestinal adverse effects. This study reinforces the overall positive benefit/risk of Somatuline® Autogel® 120mg in acromegalic patients and provides new data to further explore its potential use as an alternative to frontline surgery for treatment-naïve patients with GH-secreting macroadenoma”.Pr Philippe J. Caron, Investigator of PRIMARYS, Head of Endocrinology and Metabolic diseases Unit, Toulouse (France) added: “ (...) Although the primary endpoint was not statistically met, we observe clinically relevant results as Somatuline® Autogel® 120mg was associated with early and sustained reduction in pituitary adenoma volume. 63% of patients achieved 20% or more volume reduction as well as reduction in GH/IGF-1 levels and improvement in clinical symptoms”.Five patients prematurely discontinued the PRIMARYS study due to adverse events, among which three were considered as related to the study medication by the investigator (leakage of cerebral fluid, deterioration of hypertension and hair loss).Most patients reported mild (57/90 [63%]) and/or moderate AEs (36/90 [40%]), but only 5/90 discontinued due to AEs (6%). In the absence of a control group, it is challenging to determine whether adverse events were related to the study drug. The safety profile observed in the study is consistent with the known safety profile of Somatuline®. The most frequent treatment emergent adverse events were gastrointestinal disorders, alopecia, cholelithiasis and fatigue.
