Adding nintedanib to chemotherapy led to a 64 percent increase in the time it took for mesothelioma patients’ disease to progress, compared with chemo alone, according to updated results of a Phase 2 clinical trial.
The therapy’s developer, Boehringer Ingelheim, sponsored the LUME-Meso clinical trial (NCT01907100), which covered 87 patients. It assessed the safety and effectiveness of adding oral nintedanib to a standard-of-care chemotherapy.
A combination of nintedanib and chemo led to malignant pleural mesothelioma progressing — or patients dying — after 9.4 months, versus 5.7 months in patients treated with chemo alone.
“We are pleased to see that the addition of nintedanib to standard first-line chemotherapy may translate into meaningful improvements in patients’ outcomes,” Dr. Mehdi Shahidi, a Boehringer Ingelheim vice president, said in a press release. Mesothelioma “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.”
Researchers presented the updated results at the American Society of Clinical Oncology annual meeting in Chicago on June 5. The presentation was titled “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).”
Nintedanib prevents cancer from creating new blood vessels, a process known as angiogenesis that helps malignancies expand. The therapy works by targeting cell-surface receptors and proteins that promote blood-vessel creation and cancer growth.
The United States and the European Union have approved nintedanib under the brand name Vargatef to treat non-small-cell lung cancer. Boehringer Ingelheim also markets the therapy in the United States under the brand name Ofev to treat patients with idiopathic pulmonary fibrosis.
The LUME-Meso trial is an ongoing Phase 2/3 study evaluating a combination of nintedanib and chemotherapy in patients with mesothelioma that can’t be operated on.
Boehringer Ingelheim announced preliminary results of the study in December 2016 and presented them at the International Association for the Study of Lung Cancer convention in Vienna the same month.
The updated results show that the time it takes for mesothelioma to progress in patients treated with the combo therapy is 9.4 months, compared with 5.7 months in the chemo-only group. Results were even better in a subset of patients with epithelial cell mesothelioma who received the combo therapy. Their time to disease progression was 9.7 months, versus 5.7 in the placebo group.
Overall survival was also better in the combo group — 18.3 months, versus 14.2 for the placebo group. Researchers said the findings were not statistically significant, however. The overall-survival trend was the same in the epithelial cell subgroup. Combo-treated patients survived 20.6 months, versus 15.2 months for the placebo group.
There were no significant differences in adverse events between the combo and placebo groups, researchers said.
The company has begun recruiting patients for a Phase 3 extension of the study.