Abstract
BackgroundLanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; however, it is not yet approved in China. The aim of this study was to evaluate the efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release (PR) in Chinese patients with active acromegaly.MethodsLANTERN was a phase 3, randomized, open-label, non-inferiority study. Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks. Primary endpoint was mean change-from-baseline in age-adjusted insulin-like growth factor-1 (IGF-1) standard deviation scores (SDS) at the end-of-study. Secondary endpoints included: growth hormone (GH) levels ≤2.5 μg/L or ≤ 1.0 μg/L, ≥20% reduction in tumor volume (TV) and safety.ResultsIn total, 128 patients were randomized and received study treatment. Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was − 0.32 (− 0.74, 0.11; per protocol population) and − 0.27 (− 0.63, 0.09; intention-to-treat [ITT] population), respectively. Reductions in IGF-1 (− 6.453 vs − 7.003) and GH levels (− 9.548 μg/L vs − 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (− 20.3% vs − 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively. In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in TV compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT). Safety profiles were similar in both treatment groups.ConclusionsLanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with active acromegaly after 32 weeks of treatment.Trial registrationRetrospectively registered on ClinicalTrials.gov: NCT02493517 (9 July 2015); prospectively registered on chinadrugtrials.org.cn: CTR20140698 (24 October 2014).
Highlights
Lanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; it is not yet approved in China
Reductions in insulin-like growth factor-1 (IGF-1) (− 6.453 vs − 7.003) and growth hormone (GH) levels (− 9.548 μg/L vs − 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (− 20.3% vs − 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg prolonged release (PR) groups, respectively
In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in tumor volume (TV) compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT)
Summary
Lanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; it is not yet approved in China. For patients who do not go into complete remission following surgery, or who are poor surgical candidates, medical therapy is an alternative option to counter excess GH and IGF-1 [2, 4]. Somatostatin analogs (SSAs) are the preferred type of medical therapy used to reduce GH secretion. Patients who have persistent disease following surgical resection are recommended treatment with the first-generation long acting SSAs, octreotide long-acting release (LAR) or lanreotide autogel [4]. The efficacy and safety of lanreotide autogel for the medical management of acromegaly has been demonstrated in various international studies [11,12,13,14,15,16,17]. The efficacy of lanreotide autogel has been demonstrated in terms of hormonal control and reduction of acromegaly symptoms [11, 13, 15,16,17,18], and in tumor shrinkage [17]
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