Boehringer Ingelheim. (6/5/17). "Press Release: Encouraging Phase II Survival Data for Nintedanib in Malignant Pleural Mesothelioma Presented at ASCO 2017". Ingelheim.

	Region	Chicago, IL
	Country	United States (USA)
	Organisation	Boehringer Ingelheim (Group)
	Organisation 2	American Society of Clinical Oncology (ASCO)
	Product	nintedanib
	Product 2	clinical research
	Person	Shahidi, Mehdi (Boehringer 201903– CMO before Global Head Oncology joined in 2005)

> Oral nintedanib plus standard chemotherapy (pemetrexed/cisplatin) demonstrated a 46% reduction in the risk of disease progression in patients with inoperable malignant pleural mesothelioma (MPM) compared to placebo plus standard chemotherapy1

> Overall survival (OS) was also prolonged with the addition of nintedanib to standard chemotherapy1

Boehringer Ingelheim today announced that Phase II results from LUME-Meso, a randomised, double-blind, placebo-controlled trial, have been presented as part of an Oral Abstract Session at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO). Nintedanib*, an oral triple angiokinase inhibitor, demonstrated improved progression-free survival (PFS, primary endpoint) and overall survival (OS, secondary endpoint) when added to standard first-line chemotherapy of pemetrexed/cisplatin in patients with malignant pleural mesothelioma (MPM) compared to chemotherapy alone.1 In this study, treatment with nintedanib or placebo continued after chemotherapy until progression or toxicity.1

MPM is a rare thoracic cancer, representing less than 1% of all cancers and is often related to long-term asbestos exposure.2 MPM patients have a poor prognosis, with less than 10% surviving for five years following diagnosis.3 MPM is broadly categorised by cell type, or histology, in three subtypes (epithelioid, biphasic and sarcomatoid) with epithelioid being the most common, accounting for 50%-70% of all diagnoses.4

The updated Phase II PFS results from the LUME-Meso study showed oral, twice-daily nintedanib, when added to standard chemotherapy, nearly halved the risk of disease progression.1 A 46% reduction was demonstrated, with a significant improvement in median PFS of 3.7 months (9.4 nintedanib vs 5.7 placebo) in the overall study population (patients with either an epithelioid or biphasic cell type) compared to placebo plus standard chemotherapy alone. In patients with an epithelioid cell type, nintedanib plus chemotherapy demonstrated a greater median PFS benefit of 4 months (9.7 nintedanib vs 5.7 placebo).1

The primary OS analysis showed an encouraging 4.1 month improvement in the median OS for patients receiving nintedanib in addition to chemotherapy (18.3 nintedanib vs 14.2 placebo), demonstrating a positive trend in the overall population, without reaching significance.1 Similarly to PFS, the effect was the greatest in patients with epithelioid histology, whose median overall survival was 20.6 months compared to 15.2 months with chemotherapy alone.1

The safety profile of the experimental combination with nintedanib was as expected.1 Neutropenia (an abnormally low level of neutrophils, a type of white blood cell) was the most frequent grade =3 adverse event (nintedanib 43.2% vs placebo 12.2%); rates of febrile neutropenia were low (2.3% vs 0%). AEs leading to discontinuation were low, with fewer patients discontinuing treatment with nintedanib than in those patients in the placebo plus chemotherapy arm (3 patients vs. 7 patients; 6.8% vs 17.1%).1 Typical AEs observed with anti-angiogenesis compounds (e.g. hypertension, bleeding, thromboembolic event) were seen infrequently.1

Dr. Mehdi Shahidi, Corporate Vice President and Global Head of Oncology, Medicine at Boehringer Ingelheim commented, “We are pleased to see that the addition of nintedanib to standard first-line chemotherapy may translate into meaningful improvements in patients’ outcomes. MPM is a difficult-to-treat disease and these data are another encouraging step on our way to fulfilling the commitment of Boehringer Ingelheim to deliver novel therapeutic options to patients with malignant diseases.”

Nintedanib is currently being studied in the LUME-Meso Phase III trial [NCT01907100 (link is external)] and is recruiting at trial sites worldwide. Nintedanib targets the receptors of the VEGF, FGF, PGF and Src and Abl signaling, which are implicated in the development of malignant pleural mesothelioma.

Notes to editors

Intended audiences

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About LUME-Meso Phase II Trial Results

https://www.boehringer-ingelheim.com/sites/default/files/Prescription%20Medicine/Oncology_prescription_medicine/LUMEMesoTrialDesignInfographic_1.pdf

About Malignant Pleural Mesothelioma

https://www.boehringer-ingelheim.com/sites/default/files/Documents/Mesothelioma_Backgrounder_2017-03.pdf

About Nintedanib in Oncology

https://www.boehringer-ingelheim.com/sites/default/files/Documents/Nintedanib_in_Oncology_Backgrounder.pdf

About Boehringer Ingelheim in Oncology

https://www.boehringer-ingelheim.com/sites/default/files/Documents/Boehringer_Ingelheim_in_Oncology_Backgrounder.pdf

About Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day-by-day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com

Footnotes

* Nintedanib is approved in the EU and more than 20 other countries worldwide under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is not approved in other oncology indications.

References

1. Nowak A. et al. Mature overall survival (OS) results from the LUME-Meso study of nintedanib (N) + pemetrexed/cisplatin (PEM/CIS) vs placebo (P) + PEM/CIS in chemo-naïve patients (pts) with malignant pleural mesothelioma (MPM). (Abstract #8506) at American Society of Clinical Oncology, Chicago, June 5, 2017.

2. Moore A. et al. Malignant mesothelioma. Orphanet J Rare Dis. 2008; 3(34).

3. The American Cancer Society. Mesothelioma. Available at: https://www.cancer.org/cancer/malignant-mesothelioma/detection-diagnosis-staging/survival-statistics.html [Last accessed June 2017]

4. Mesothelioma Group. Available at: https://www.mesotheliomagroup.com/mesothelioma/cell-types/epithelioid/ [Last assessed June 2017]

Media Contact

Dr Julia Knebel
Media Contact
Media & PR
Phone +49 6132 77 2356
Fax +49 6132 77 6601
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY

Record changed: 2023-06-05