Update on LUME-Meso Clinical Trial

Update on LUME-Meso

The primary analysis of data from LUME-Meso, a clinical Phase III trial comparing nintedanib in combination plus pemetrexed/cisplatin versus pemetrexed/cisplatin alone for the treatment of malignant pleural mesothelioma, was conducted after the predefined number of progression free survival (PFS) events was reached.

The analysis shows that the primary endpoint PFS was not met with no difference between the treatment groups. According to the study protocol, the trial has been discontinued and study investigators, health authorities and ethics committees were informed.

The observed safety profile is consistent with the experience from previous trials and the known safety profile of nintedanib. There were no unexpected major safety findings in the study.

Boehringer Ingelheim is conducting a comprehensive analysis of the final data set from the LUME-Meso trial. We will submit the full study results to an upcoming scientific congress and are planning to publish the results in an appropriate medical journal.

Boehringer Ingelheim would like to thank all patients and investigators for participating in this study and we are disappointed to not be able to offer a potential new treatment option for them. We remain dedicated to our strong cancer research programs designed to improve clinical practice, transform the lives of patients and contribute to winning the fight against cancer.