Extended duration of injection interval

2

Lucas et al.

Efficacy of lanreotide Autogel® administered every 4–8 weeks in patients with acromegaly previously responsive to lanreotide microparticles, 30 mg: a Phase III trial1Lucas T, 2Astorga R and the Spanish–Portuguese Multicentre Autogel Study Group on Acromegaly1Service of Endocrinology, Clínica Puerta de Hierro, Madrid, Spain; 2Service of Endocrinology, Hospital ‘Virgen del Rocío’, Sevilla, Spain

Manuscript accepted for publication in Clin Endocrinol

• Study number: A92 52030 046

• Poster presented at ECE 2005

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Lucas et al. – Objectives

• Confirm equivalent efficacy of lanreotide Autogel, 120 mg, administered at intervals of 4, 6 or 8 weeks, and lanreotide microparticles, 30 mg, administered every 7–14 days to patients with acromegaly

• Compare the safety of the two formulations

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Lucas et al. – Design and Methods

• Phase III, open, multicentre, crossover study

• 97 patients with active acromegaly Receiving lanreotide microparticles, 30 mg, fixed injection intervals for at least 2

months Switched to lanreotide Autogel, 120 mg Lanreotide microparticles every 14 days lanreotide Autogel, every 8 weeks Lanreotide microparticles every 10 days lanreotide Autogel, every 6 weeks Lanreotide microparticles every 7 days lanreotide Autogel, every 4 weeks

• Blood samples taken before final injection of lanreotide microparticles and Autogel, and in final dosing period for lanreotide Autogel

• Symptoms of acromegaly assessed at the beginning and end of study

• Systemic and local tolerability recorded after each injection

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Lucas et al. – Results (1)

Both formulations showed similar efficacy in reducing serum GH; similar efficacy for each of the injection frequencies of lanreotide Autogel

0

50

125

150

Mean GH ratio Lanreotide Autogel/microparticles

Lanreotide Autogel 120 mg

100

75

25

175

28 days 42 days 56 days

Day0

1 2 3 4Week

Day0

1 2 4 6Week

Day0

1 2 5 8Week

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Lucas et al. – Results (2)

Lanreotide microparticles

Lanreotide Autogel

GH level at end dosing period

4.3 ng/ml 3.8 ng/ml

Patients with GH < 2.5 ng/ml 46% 54% Patients with GH < 2.5 ng/ml and IGF-1 control

35% 40%

Biological markers

• Plasma concentrations of IGF-1 did not change significantly over the course of the study

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Lucas et al. – Results (3)

Symptoms of acromegaly • Symptoms of acromegaly generally mild or moderate in intensity

• Greater symptom control achieved at the end of treatment with lanreotide Autogel compared with lanreotide microparticles

Tolerability • As expected, most common adverse events were gastrointestinal

• Local tolerability comparable for the two formulations

Other endpoints • Lanreotide Autogel well accepted by patients: mean acceptance score 8.3/10

• Acceptance similar between dosing groups

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Lucas et al. – Conclusions

• Lanreotide Autogel, 120 mg every 4–8 weeks, at least as effective and well tolerated as lanreotide microparticles, 30 mg, every 7–14 days

• Lanreotide Autogel well accepted by patients

• Longer dosing interval of lanreotide Autogel, 120 mg, maintains the same overall monthly dose as lanreotide microparticles, 30 mg, but has benefits in cost and patient compliance

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Lucas et al. – Key Messages

• Lanreotide Autogel, 120 mg, every 4–8 weeks as effective as lanreotide microparticles, 30 mg every 7–14 days

• Lanreotide Autogel, presented in a pre-filled syringe is convenient for patients and clinicians

• Lanreotide Autogel is the only somatostatin analogue approved for use with this extended dosing interval

• The longer dosing period provides: Greater ease of use and convenience A reduced number of clinic visits Cost savings Improved patient compliance