Efficacy and safety of lanreotide autogel compared with lanreotide 40?mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN)

摘要

Lanreotide 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. LANTERN 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. In 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. Lanreotide autogel was non-inferior to lanreotide 40?mg PR in Chinese patients with active acromegaly after 32?weeks of treatment. Retrospectively registered on ClinicalTrials.gov: NCT02493517 (9 July 2015); prospectively registered on chinadrugtrials.org.cn: CTR20140698 (24 October 2014).