nintedanib (AST-2521) / Austhera Biosci - LARVOL DELTA

'Boehringer’s new pulmonary fibrosis therapy shows promise… (Korea Biomedical Review) - "Both studies confirmed about a 40 percent reduction in decline compared to placebo....Safety outcomes were also favorable. The most common adverse event was mild diarrhea, reported in about 27 percent of patients -- less than half the incidence typically seen with nintedanib, which affects up to 65 percent of patients."

P3 data • Idiopathic Pulmonary Fibrosis

Nintedanib: “The committee was reminded of the status of this application and its remaining outstanding issues”; Idiopathic Pulmonary Fibrosis (European Medicines Agency) - CHMP Final Minutes of the meeting on 24 - 27 Feb 2025: “The committee adopted a list of outstanding issues with a specific timetable.”

CHMP • Idiopathic Pulmonary Fibrosis

Effect of nintedanib on forced vital capacity (FVC) decline in patients with combined emphysema and pulmonary fibrosis syndrome: data from the INBUILD trial (CPLF 2024) - No abstract available.

Clinical

National Multicenter Study on the Real-life Use of Nintedanib in PIDSSc [Google translation] (CPLF 2024) - No abstract available.

National multicenter study on the use of NINTEDANIB in real life in PIDSSc (CPLF 2024) - No abstract available.

Effect of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis and Emphysema of Different Extents on High-Resolution Computed Tomography (HR-CT) (CPLF 2024) - No abstract available.

Clinical

Gut-Friendlier Dose of Nintedanib Finally Backed by Some Data - Clinical outcomes in idiopathic pulmonary fibrosis similar between high, low doses (MedPageToday) - "'At least on this preliminary data, you can be a little rest assured,' said Andrew Limper, MD..."

Media quote • Idiopathic Pulmonary Fibrosis

The Role of Somatostatin Analogue Maintenance Therapy in Refractory Metastatic Neuroendocrine Tumors (NETs): Comparative Analysis (NANETS 2023) - P=NA | N=4,319 | "Addition of maintenance SSAs to targeted therapies was not associated with significant benefit in tumor control in patients with refractory metastatic NETs. These results need to be validated in prospective randomized controlled trials designed to include both survival benefit and associated financial toxicity."

Clinical data

Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Three-Year Data from SENSCIS-ON (GREC 2023) - No abstract available.

EULAR now recommends the use of immunosuppressants for systemic sclerosis [Google translation] (Medscape) - "'For the first time, synthetic and targeted drugs are now recommended for [the treatment of] interstitial lung disease associated with systemic sclerosis; among the drugs included were: mycophenolate mofetil, nintedanib, rituximab and tocilizumab. None of these were mentioned [in the previous recommendations]. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not mentioned in 2017,' explained Dr. Francesco Del Galdo, MD..."

Media quote

EULAR systemic sclerosis recommendations now include immunosuppressants (Mdedge Rheumatology) - "Dr. Del Galdo said that the three vascular manifestations of scleroderma - Raynaud's, pulmonary arterial hypertension, and digital ulcers - were treated with the same drugs, all with a similar grade of evidence....Ariane Herrick, PhD...shared her thoughts on the guidelines. 'These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.'"

Media quote

EULAR23 - Prof Yannick Allanore interview (YouTube) - "...interview at Prof Yannick Allanore in 'updates in the treatment with nintedanib in patients wth SSc - ILD : three-years data from SENSCIS' at EULAR2023."

Interview • Video

Nintedanib Remains Safe for SSc-ILD Through 3 Years (HCPLive) - "The long-term extension SENSCIS-ON trial shows patients receiving nintedanib over 3 years were not at significantly greater risk of serious adverse events or outcomes....Led by Yannick Allanore, MD, PhD...conducted the open-label extension of SENSCIS to further investigate adverse events and FVC decline in patients with SSc-ILD treated with nintedanib over the period of a few years."

Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease: Three-Year Data from SENSCIS-ON (CCR 2023) - "The continued nintedanib group comprised 197 patients and the initiated nintedanib group comprised 247 patients (231 from SENSCIS, 16 from the DDI study). In these groups, respectively, mean (SD) FVC at the start of SENSCIS-ON was 2379 (754) mL and 70.4 (18.1) % predicted and 2443 (814) mL and 70.8 (17.9) % predicted. In total, 126 (64.0%) and 125 (50.6%) patients in the continued nintedanib and initiated nintedanib groups, respectively, were still receiving nintedanib at week 148 of SENSCIS-ON. Diarrhea was the most frequent adverse event (Table). Serious adverse events were reported in 76 (38.6%) patients in the continued nintedanib group and 95 (38.5%) patients in the initiated nintedanib group."

Systemic Sclerosis

Place and role of nintedanib in treatment of IPF and PPF (RESPIMED 2023) - No abstract available.

Idiopathic Pulmonary Fibrosis Podcast - Episode 2: Idiopathic Pulmonary Fibrosis: Who Gets an Antifibrotic? (Medscape) - "I'm Dr Jeff Swigris. Today we'll be discussing antifibrotic therapy for patients with IPF. We're going to be tackling some questions, such as: Should every patient with IPF be on an antifibrotic? How do we decide which antifibrotic to use? What happens if my patient progresses more than I would expect them to despite being on an antifibrotic? And finally, what are some key points we all need to know about acute exacerbations?"

Audio

Genetics Play a Role in Pulmonary Fibrosis [Google translation] - "New research has shown that about every third patient with idiopathic pulmonary fibrosis (IPF) has genetic risk factors, Behr explained....For therapy, nintedanib is recommended. Studies show that it has an overall positive effect on the course of the disease in PPF, Behr emphasized."

Media quote

Real-life multicentric national observational study of the use of nintedanib in systemic sclerosis-associated interstitial lung disease (ERN ReCONNET 2023) - No abstract available.

Continued nintedanib treatment in patients with progressive pulmonary fibrosis: Interim analysis of INBUILD-ON (AMCP 2023) - No abstract available.

Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease: Three-year data from SENSCIS-ON (AMCP 2023) - No abstract available.

Systemic Sclerosis

NICE recommends new treatment for EGFR-positive lung cancer (European Pharmaceutical Review) - "Professor Sanjay Popat...stated: 'Mobocertinib [is] not only a proven effective targeted treatment but one that can be taken orally at home...This positive decision from NICE means that clinical management of this devastating type of lung cancer is brought more in line with other forms of the disease where targeted treatments are already routinely available.'"

Media quote

Treatment and Management of Interstitial Lung Disease (ILD) - Episode 19: Conditional Recommendation of Nintedanib and Use in ILD Treatment (AJMC) - "Nintedanib recommendations for use from the recent ATS guidelines and treatment implementation are considered by Paul Noble, MD."

Video • Interstitial Lung Disease

Following Computational Predictions, Scientists Demonstrate that Cancer Drug Counters Pulmonary Fibrosis (Yale School of Medicine) - "An experimental cancer drug with a favorable safety profile shows promise as a treatment for Idiopathic Pulmonary Fibrosis (IPF), according to a study published on August 23, 2022 in the American Journal of Respiratory and Critical Care Medicine by Yale School of Medicine, Mount Sinai, and National Jewish researchers....Lead researchers include...Maria L. Padilla, MD...Naftali Kaminski, MD..."

Media quote

Continued Treatment with Nintedanib in Patients with Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD): Two-Year Data from SENSCIS-ON (DGRh-DGORh-GKJR 2022) - No abstract available.

Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid decline in forced vital capacity: further analyses of the SENSCIS trial (DGRh-DGORh-GKJR 2022) - No abstract available.