Boehringer Ingelheim is enrolling patients with inoperable malignant pleural mesothelioma (MPM) into a Phase 2/3 trial evaluating the effectiveness of nintedanib in combination with Alimta (pemetrexed) and Platinol (cisplatin), followed by maintenance with nintedanib versus placebo plus Alimta/Cisplatin followed by placebo.
The study, presented recently at the 16th World Conference on Lung Cancer, held Sept. 6-9, in Denver, Colo., was titled “P2.01: LUME-MeSO: Phase II/III Study of Nintedanib + Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Track: SCLC, Mesothelioma, Thymoma.”
Current standard of care for patients with unresectable, or inoperable, MPM is the combination of Alimta and Platinol, but the survival rates of these patients are still very poor, with a median overall survival of one year, revealing the need for additional improvement in therapy.
Boehringer’s nintedanib, marketed under the brand names Ofev and Vargatef is commonly used to treat idiopathic pulmonary fibrosis in the U.S. and E.U., and for some cases of non-small cell lung cancer in the E.U., has emerged as a possible therapy for patients with MPM. It inhibits a variety of signaling pathways involved in tumor angiogenesis (generation of new blood vessels), growth and metastasis, including the VEGF (vascular endothelial growth factor) pathway. Inhibiting the VEGF pathway in combination with Avastin (bevacizumab) has been validated as a treatment approach for MPM.
The LUME-Meso trial (NCT01907100) is an international, double-blinded, randomized, placebo-controlled, Phase 2/3 study evaluating the safety and efficacy of nintedanib plus Alimta/Platinol in patients with inoperable MPM. The study was extended from a Phase 2 trial Phase 2/3 trial following a review from the internal data monitoring committee.
The study is expected to enroll 537 adult chemo-naive MPM patients (87 patients in Phase 2 and 450 patients in Phase 3), who will be randomized to receive up to six cycles of Alimta (500 mg/m²) and Platinol (75 mg/m²) on day 1, plus nintedanib or placebo on days 2-21.
After that period, patients without disease progression will receive nintedanib mono-therapy as a maintenance treatment until their disease progresses. The study’s primary goal is progression-free survival; secondary goals include overall survival, objective tumor response, and disease control.
Researchers also will address the safety of nintedanib treatment by measuring the frequency and severity of adverse events and health-related quality of life. In addition, tumor and blood samples will be analyzed for possible predictive biomarkers.
The study will be conducted in 101 locations in 27 different countries. Study locations and detailed eligibility criteria can be found here.