Boehringer Ingelheim announced the enrollment of a first patient in the LUME-Meso clinical trial, a Phase 2/3 study evaluating the safety and efficacy of nintedanib (Vargatef) in combination with pemetrexed/cisplatin, followed by continuing nintedanib monotherapy, as a first-line treatment for people with unresectable malignant pleural mesothelioma (MPM).
The study, currently recruiting patients, follows European Union (EU) approval of nintedanib in combination with docetaxel for the treatment of locally advanced, metastatic, or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.
The clinical trial, “Nintedanib (BIBF 1120) in Mesothelioma” (NCT01907100), plans to enroll 397 patients who will be randomized to two groups — nintedanib in combination with pemetrexed/cisplatin, or placebo in combination with pemetrexed/cisplatin. Patients qualify for enrollment if they are not eligible for mesothelioma surgical resection, have undergone no first-line treatments for MPM, and hold an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Its primary endpoint is progression-free survival, as measured from the time of randomization to the time of disease progression or death. The trial, being conducted at 72 centers worldwide, is expected to finish in August 2018.
“Malignant pleural mesothelioma is a rare cancer and despite years of research, patients continue to have a poor prognosis — less than 10% survive for five years following diagnosis. Due to the mode of action of nintedanib, it has the potential to be an effective treatment option for patients with pleural mesothelioma,” Professor Giorgio Scagliotti, the trial’s lead investigator and chair of the Department of Oncology, University of Torino, said in a news release.
Nintedanib targets receptors of the vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), and proto-oncogene tyrosine-protein kinase (Src) pathways, all of which are involved in tumor growth and metastasis in MPM. At present, no targeted therapies are approved for MPM treatment.
“Over the last few years Boehringer Ingelheim has accumulated considerable expertise in the field of thoracic oncology. With the approval of Giotrif® and Vargatef® as well as a broad clinical pipeline we are building up a strong presence in this setting. The effort to develop a potential efficacious treatment for malignant pleural mesothelioma demonstrates our long-term commitment for patients with significant unmet medical need,” said Dr. Jörg Barth, corporate senior vice president and Therapy Area head of Oncology at Boehringer Ingelheim.
More information on the clinical trial, including how to participate, is available through this link.