Wednesday, December 7, 2016

Clinically meaningful data for oral nintedanib in mesothelioma presented at World Conference on Lung Cancer

INGELHEIM, Germany & VIENNA - Wednesday, December 7th 2016 [ME NewsWire]

    Mesothelioma is a rare and difficult-to-treat cancer with no targeted treatment options currently approved
    Oral triple angiokinase inhibitor nintedanib meets primary endpoint of progression-free survival (9.4 vs 5.7 months) and significantly reduced the risk of disease progression by 44% in Phase II study versus standard of care
    Phase III extension trial (LUME-Meso [NCT01907100]) is currently recruiting patients worldwide

(BUSINESS WIRE)-- Boehringer Ingelheim today announced that the LUME-Meso Phase II trial in patients with unresectable malignant pleural mesothelioma (MPM) met its primary endpoint of progression-free survival (PFS). The data presented at the 17th IASLC World Conference on Lung Cancer in Vienna, showed nintedanib* plus pemetrexed/cisplatin demonstrated a meaningful clinical benefit compared to placebo plus pemetrexed/cisplatin, with a significantly improved PFS (9.4 vs 5.7 months, HR = 0.56 and p value =0.0174). Preliminary overall survival (OS) data also favoured nintedanib (18.3 vs 14.5 months, HR = 0.78 and p=0.4132).

Nintedanib (VARGATEF®) in combination with docetaxel was approved in the EU in 2014 for use in adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

Lead investigator Professor Giorgio V. Scagliotti, University of Torino, Chair of the Department of Oncology, Italy, commented, “No targeted therapies are currently approved for the treatment of mesothelioma, a rare and difficult-to-treat cancer. The prognosis of MPM is poor, with a median survival of 9 to 12 months from diagnosis. We are very encouraged by these recent data; the results have led to an extension of the study into a Phase III confirmatory trial that is now underway and will provide further insight into the potential of nintedanib for patients with MPM.”

MPM is a rare cancer that affects the cells that make up the mesothelium of the pleura - the lining or membrane that covers and protects the lungs. It represents less than 1% of all cancers and is often related to long-term asbestos exposure.

The most common adverse events (≥grade 3) occurring in nintedanib versus placebo patients were low concentration of neutrophils in the blood (neutropenia), 34% vs 10%; elevated liver enzymes, 14% vs 2% and an increase in gamma glutamyltransferase, 14% vs 0%.

Dr. Victoria Zazulina, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim said, “Our oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Current treatment options for unresectable malignant pleural mesothelioma are limited and we are focussed on developing a targeted treatment option that will fit the needs of patients.”

The LUME-Meso trial results will be presented today (14:25 – 14:35 CET) as an oral presentation at the 17th IASLC World Conference on Lung Cancer 2016 in Vienna, Austria, (Abstract ID #4191 #OA22.02).

* Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

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Boehringer Ingelheim

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Julia Knebel

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Tel.: +49 (6132) 77-95614

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