FP27-3 Inhibition of GH and IGF-1 Is Maintained with Pasireotide LAR and Octreotide LAR in Patients with Acromegaly: 12-Month Extension Phase of a Double-Blind, Multicenter, Randomized, Phase III Study

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: FP27-Pituitary: Acromegaly and Prolactinoma
Clinical
Sunday, June 16, 2013: 10:45 AM-11:15 AM
Presentation Start Time: 10:55 AM
Room 135 (Moscone Center)

Poster Board SUN-88
Michael C Sheppard*1, Marcello D Bronstein2, Pamela U Freda3, Omar Serri4, Laura De Marinis5, Luciana Ansaneli Naves6, Liudmila Rozhinskaya7, Karina Hermosillo Reséndiz8, Matthieu Ruffin9, Kobby Asubonteng8 and Annamaria Colao10
1University of Birmingham, Birmingham, United Kingdom, 2University of São Paulo Medical School, São Paulo, Brazil, 3Columbia University College of Physicians & Surgeons, New York, NY, 4Notre-Dame Hospital, University of Montreal, Montreal, QC, Canada, 5Università Cattolica del Sacro Cuore, Rome, Italy, 6University of Brasilia, Brasilia, Brazil, 7Endocrinology Research Centre, Moscow, Russia, 8Novartis Pharmaceuticals Corporation, Florham Park, NJ, 9Novartis Pharma AG, Basel, Switzerland, 10Università Federico II di Napoli, Naples, Italy
Introduction: Pasireotide LAR demonstrated significantly superior efficacy in terms of biochemical control to octreotide LAR in a 12-month trial in 358 medically naïve patients with acromegaly. Patients with clinical benefit or GH<2.5µg/L and IGF-1≤ULN could continue therapy in the extension study.

Methods: Patients entering the extension (pasireotide LAR, n=74; octreotide LAR, n=46) were followed up to month 26 (core plus extension) for octreotide LAR, whereas pasireotide LAR patients could continue beyond month 26. Dose titration to pasireotide LAR 60mg/28d or octreotide LAR 30mg/28d (if GH≥2.5µg/L and/or IGF-1>ULN) or to pasireotide LAR 20mg/28d or octreotide LAR 10mg/28d (for tolerability issues) was permitted in the core and extension.

Results: Mean duration of exposure was 465 days in the pasireotide LAR arm and 412 days in the octreotide LAR arm. 51 pasireotide LAR and 36 octreotide LAR patients completed month 26. Suppression of GH and IGF-1 was maintained throughout the extension in both arms. Median GH (µg/L) and IGF-1 (x ULN) in pasireotide LAR vs octreotide LAR patients were: 8.8 vs 10.1 and 2.9 vs 2.9 at baseline; 1.9 vs 2.0 and 0.9 vs 1.3 at month 12; and 1.0 vs 1.0 and 0.6 vs 0.9 at month 25. Median percentage change in GH at month 25 was –83% with pasireotide LAR and –86% with octreotide LAR. Median percentage change in IGF-1 at month 25 was –71% with pasireotide LAR and –64% with octreotide LAR. Median percentage change in tumor volume from core baseline to month 25 was –54.1% (n=54) for pasireotide LAR and –57.3% (n=34) for octreotide LAR. Both treatments improved acromegaly symptom scores. Most common AEs during the core and extension in both treatment arms were diarrhea, cholelithiasis, hyperglycemia, headache, diabetes mellitus. Hyperglycemia-related AEs were more frequent with pasireotide LAR than octreotide LAR (62.9% [n=112/178] vs 25.0% [n=45/180]).

Conclusions: These results suggest that pasireotide LAR and octreotide LAR provide long-term inhibition of GH and IGF-1 in patients with acromegaly.

Disclosure: MCS: Consultant, Novartis Pharmaceuticals, Speaker, Novartis Pharmaceuticals. MDB: Investigator, Novartis Pharmaceuticals, , Ipsen, Committee Member, Chiasma, Committee Member, Novartis Pharmaceuticals, Speaker, Ipsen, Speaker, Novartis Pharmaceuticals. PUF: Medical Advisory Board Member, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals. LDM: Investigator, Novartis Pharmaceuticals. LR: Investigator, MSD, Speaker, Novartis Pharmaceuticals, Investigator, Novartis Pharmaceuticals, Speaker, MSD, Speaker, Amgen, Investigator, Amgen. KHR: Employee, Novartis Pharmaceuticals. MR: Employee, Novartis Pharmaceuticals, Employee, Novartis Pharmaceuticals. KA: Employee, Novartis Pharmaceuticals. AC: Committee Member, Novartis Pharmaceuticals. Nothing to Disclose: OS, LAN

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm