Searchable abstracts of presentations at key conferences in endocrinology

ea0099p326 | Pituitary and Neuroendocrinology | ECE2024

A randomised phase 3 trial to assess efficacy and safety of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly

Ferone Diego , Silverstein Julie , Freda Pamela , Katznelson Laurence , Gatto Federico , Kadioglu Pinar , Maffei Pietro , Seufert Jochen , L. Spencer-Segal Joanna , Isaeva Elena , Dreval Alexander , Harrie Maria , Svedberg Agneta , Tiberg Fredrik

Background: Acromegaly is a rare endocrine disorder characterised by excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1) that is associated with significant morbidity and impaired quality of life (QoL). Standard-of-care (SoC) treatments for acromegaly typically require healthcare provider administration, pose a substantial treatment burden, and leave scope for improved disease control. CAM2029, an octreotide subcutaneous depot with ~5x higher bioavailability th...

ea0099ep320 | Pituitary and Neuroendocrinology | ECE2024

An open-label long-term Phase 3 study of CAM2029 in patients with acromegaly (ACROINNOVA 2): interim analysis of the subgroup of patients ‘new to CAM2029’ with controlled or uncontrolled acromegaly on standard-of-care treatment

Ferone Diego , L. Spencer-Segal Joanna , Fidan Yaylali Guzin , Doknic Mirjana , Isaeva Elena , Dreval Alexander , Gilis-Januszewska Aleksandra , Gezer Emre , Bancos Irina , Katznelson Laurence , Harrie Maria , Svedberg Agneta , M. Pedroncelli Alberto , Tiberg Fredrik

Background: Acromegaly, a rare, chronic disorder, results from excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The need for convenient therapies that provide effective disease control led to the development of CAM2029, a novel, subcutaneous, octreotide depot designed for convenient monthly self-administration using pre-filled syringes/injection pens. In a 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) CAM2029 achieved superior IGF-1 control vs placeb...

ea0099ep321 | Pituitary and Neuroendocrinology | ECE2024

An open-label long-term Phase 3 study of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly (ACROINNOVA 2): interim analysis of the ACROINNOVA 1 roll-over patients subgroup

Ferone Diego , Silverstein Julie , Freda Pamela , Katznelson Laurence , Gatto Federico , Kadioglu Pinar , Maffei Pietro , Seufert Jochen , L. Spencer-Segal Joanna , Isaeva Elena , Dreval Alexander , Harrie Maria , Svedberg Agneta , M. Pedroncelli Alberto , Tiberg Fredrik

Background: Acromegaly is a neuroendocrine disorder, characterised by growth hormone (GH) and insulin-like growth factor 1 (IGF-1) overproduction. Persistent biochemical control to minimise adverse effects of prolonged excess GH/IGF-1 is a key treatment goal. CAM2029 is a novel octreotide depot, designed for convenient monthly subcutaneous self-administration, using pre-filled syringes/injection pens. A 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) evaluated CAM2029 in pat...

ea0073oc13.6 | Oral Communications 13: Pituitary and Neuroendocrinology | ECE2021

A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands

Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Grineva Elena , Poteshkin Yury E. , Gilgun-Sherki Yossi G , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Biermasz Nienke , Melmed Shlomo K. , Strasburger Yossi G

BackgroundMPOWERED, a large phase 3 trial, assessed maintenance of response to oral octreotide capsules (OOC; MYCAPSSA) compared to injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly who responded to OOC and iSRLs (octreotide or lanreotide). OOC were recently approved in the US for patients with acromegaly who responded to and tolerated iSRLs.MethodsEligibility criteria included age ...

ea0073pep3.2 | Presented ePosters 3: Pituitary and Neuroendocrinology | ECE2021

Safety results from MPOWERED, a phase 3 trial of oral octreotide capsules in adults with acromegaly

Freda Pamela U. , Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Huang Wenyu , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Biermasz Nienke , Melmed Shlomo K. , Strasburger Christian J.

BackgroundInjectable somatostatin receptor ligands (iSRLs) have been a mainstay in acromegaly treatment. Oral octreotide capsules (OOC; MYCAPSSA®) were recently approved in the USA. Results from the placebo-controlled CHIASMA OPTIMAL and open-label CH-ACM-01 studies showed an OOC safety profile consistent with that of iSRLs with no new or unexpected safety signals. Results of the MPOWERED trial have enabled a comparison of OOC safety and ...

ea0073pep8.1 | Presented ePosters 8: Pituitary and Neuroendocrinology | ECE2021

Oral octreotide capsules lowered incidence and improved severity of acromegaly symptoms compared to injectable somatostatin receptor ligands—results from the MPOWERED trial

Biermasz Nienke , Fleseriu Maria , Dreval Alexander V , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E , Macut Djuro P , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H , Patou Gary , Haviv Asi , Gordon Murray B , Urbanavicius Vaidotas , Knispelis Robertas , Melmed Shlomo K , Strasburger Christian J

BackgroundPatients with acromegaly may have high symptom burden. The phase 3 MPOWERED trial assessed control of acromegaly by oral octreotide capsules (OOC; MYCAPSSA®) in comparison to injectable somatostatin receptor ligands (iSRLs) in patients responding to both OOC and iSRLs. iSRLs have been first-line medical treatment for patients with acromegaly for decades. OOC are newly approved in the US for patients previously controlled on iSRL...

ea0073pep8.3 | Presented ePosters 8: Pituitary and Neuroendocrinology | ECE2021

Addition of cabergoline to oral octreotide capsules may improve biochemical control in patients with acromegaly who are inadequately controlled with monotherapy

Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Verbovoy Andrey , Dogadin Sergey A. , Biermasz Nienke , Strasburger Christian J. , Melmed Shlomo K.

BackgroundOral octreotide capsules (OOC; MYCAPSSA®) are approved in the US for individuals with acromegaly who responded to and tolerated treatment with injectable somatostatin receptor ligands (iSRLs). Add-on cabergoline therapy has shown effectiveness in patients previously inadequately controlled with iSRLS.1 The phase 3 MPOWERED trial assessed maintenance of response with OOC compared to iSRLs. Patients receiving OOC and in...

ea0073pep13.6 | Presented ePosters 13: Pituitary and Neuroendocrinology | ECE2021

Improved acromegaly patient satisfaction with oral octreotide capsules compared with injectable somatostatin receptor ligands in the MPOWERED trial

Gordon Murray B , Fleseriu Maria , Dreval Alexander V , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E , Macut Djuro P , Leonova Nina , Raverot Gerald , Kirschner Lawrence S , Chanson Philippe , Yossi Gilgun-Sherki , Ludlam William H , Patou Gary , Haviv Asi , Biermasz Nienke , Melmed Shlomo K , Christian J Strasburger

BackgroundImproved patient-reported outcomes (PROs) are increasingly becoming a key treatment objective in acromegaly. Validated PROs were used to assess disease and treatment burden in the MPOWERED phase 3 trial in acromegaly, which also assessed safety and efficacy of oral octreotide capsules (OOC; MYCAPSSA®) compared to injectable SRLs (iSRLs).MethodsEligible patients had acromegaly diagnosis, biochem...