Phase III Clinical Trial for Nintedanib Discontinued After Yielding Negative Results

Disappointing results from the LUME-Phase III clinical trial regarding nintedanib is a setback for scientists and researchers who were hopeful they were on the brink of finding a new, first line treatment for those suffering from mesothelioma.

Results from the Phase II clinical trial – published earlier this year – showed promise for the triple angiokinase inhibitor. Nintedanib is treatment designed to hinder protein kinases in cancer cells and stop cancer cells from growing their own blood vessels. As the treatment denies the cancer cells oxygen, tumor growth is significantly inhibited. The LUME-Meso Phase III trial hoped to gain enough positive results to receive FDA approval for the treatment of mesothelioma, as it is already for pulmonary fibrosis and lung cancer.

This multi-center, randomized, double blind study evaluated the efficacy and safety of the combination treatment of nintedanib and pemetrexed/cisplatin which was then followed by nintedanib alone. Control groups were given a placebo and chemotherapy, and a placebo again as the monotherapy.  Mesothelioma is typically treated with chemotherapy alone, with pemetrexed and cisplatin being the first line treatments. Results from this study showed that those who were given the combination therapy of nintedanib and chemotherapy had a progression free survival (PFS) of just 6.8 months. Those in the control group experienced a PFS of 7.0 months.

Since the results of the study yielded a lesser PFS, and side effects were largely the same, the study was discontinued. This was in accordance to the study safety protocol.

Mesothelioma is notorious for being a hard to treat cancer, with a median survival rate of only 9-12 months. There is no cure for mesothelioma, but the latest advancements in treatment have allowed some who are diagnosed to extend their survival, if only for a few months.

Bevacizumab is also a mesothelioma treatment that is similar to nintedanib. Bevacizumab fights cancer cells by restricting oxygen flow that is needed for tumor growth. Side effects from bevacizumab can be severe, which is why scientists and researchers were looking toward a new therapy in nintedanib, which in the Phase II clinical trial, had yielded more promising results.

Results of this study were presented at the IASLC 19th World Conference on Lung Cancer 2018.

 

Source:
Boehringer Ingelheim, “Results of LUME-Meso trial in malignant pleural mesothelioma presented at the 19th World Conference on Lung Cancer (WCLC 2018),” (September 25, 2018). [Link]

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Last update: March 06, 2014. 08:41:31 pm.