Boehringer Ingelheim USA Corporation

The FDA granted survodutide Breakthrough Therapy designation, developed by Boehringer Ingelheim with Zealand Pharma's discoveries.

Zealand Pharma reports Boehringer Ingelheim's U.S. FDA Breakthrough Therapy designation for survodutide in MASH and moderate or advanced fibrosis, and initiation of two Phase III trials.

FDA grants Breakthrough Therapy designation to survodutide for treating MASH and moderate or advanced fibrosis. Boehringer Ingelheim initiates two Phase III studies, LIVERAGE and LIVERAGE-Cirrhosis, to assess survodutide's efficacy in MASH patients with fibrosis and cirrhosis.

Boehringer Ingelheim receives U.S. FDA Breakthrough Therapy designation for survodutide, a dual glucagon/GLP-1 receptor agonist, for treating non-cirrhotic MASH with moderate or advanced fibrosis. The company also initiates two Phase III studies, LIVERAGE and LIVERAGE-Cirrhosis, to assess survodutide's efficacy in MASH patients with fibrosis and cirrhosis.

Zealand Pharma reports Boehringer Ingelheim's U.S. FDA Breakthrough Therapy designation for survodutide in treating non-cirrhotic MASH and moderate or advanced fibrosis, and the initiation of two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, for MASH and fibrosis.

E. Heath reports advisory/consulting, steering committee, honoraria/paid travel, speaker’s bureau, and research support from various companies. J.R. Ribeiro, K. Poorman, and J. Xiu report personal fees and other support from Caris Life Sciences. H. Mamdani reports other support and grants from Daiichi Sankyo, AstraZeneca, and Genentech. A.F. Shields reports personal fees from Caris Life Sciences. G.L. Lopes reports stock ownership, honoraria, consulting, research funding, travel, and other relationships with multiple companies. S.A. Kareff reports personal fees and travel grants from various organizations. M. Radovich and G.W. Sledge report other support from Caris Life Sciences. G.A. Vidal reports relationships with Guardant360, Gilead, BillionToOne, Genentech/Roche, GSK, and AstraZeneca. J.L. Marshall reports personal fees from Caris. No other disclosures were reported by the other authors.

NSCLC with HER2 mutations, found in 3% of advanced non-squamous cases, is associated with poor prognosis and higher incidence of brain metastases. Standard first-line chemotherapy has limited efficacy, and HER2-targeted agents lag in NSCLC treatment. Recent studies using HER2 TKIs, ADCs, and monoclonal antibodies show promising results, with Trastuzumab deruxtecan (T-DXd) achieving 55% ORR and 8.2 months mPFS in DESTINY-Lung01 trial. Zongertinib, a novel HER2-specific TKI, demonstrated 62% ORR and 97% DCR in HER2 mutation-positive NSCLC patients, with low toxicity rates, suggesting a potential better tolerated treatment option.

FDA approval of Cobenfy opens new treatment opportunities for schizophrenia, with Boehringer Ingelheim focusing on patient-centric approaches to address cognitive symptoms, affecting 24 million globally.

DPHARM 2024 focused on innovations in clinical trials, featuring keynotes on ROI, DCTs, AI, and patient perspectives. Panels discussed efficiency, AI use, and ecosystem approaches. Outside-industry speakers offered unique insights. Technologists showcased patient-centric services. Sponsors highlighted innovation and collaboration. DPHARM Idol Disrupt finalists presented disruptive technologies, with Power winning for its patient-matching platform. The event aimed to improve clinical trials for faster, more efficient medicine delivery.