|The following article features coverage from the International Association for the Study of Lung Cancer (IASLC) 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
In a surprising reversal from what was seen in a phase 2 study on nintedanib, results from the phase 3 LUME-Meso trial, released during the IASLC’s 19th World Conference on Lung Cancer, demonstrated that nintedanib had no survival benefit when combined with pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma (MPM) with epithelioid histology.
The phase 3 trial protocol was created with the results from phase 2 in mind, in which patients with this specific form of lung cancer received nintedanib in addition to a pemetrexed/cisplatin regimen. In that trial, the addition of nintedanib improved progression-free survival in patients within this subgroup.
The current study evaluated 458 systemic chemotherapy-naive patients with the epithelioid subtype of MPM who were randomly assigned to receive combination therapy (500 mg/m2 pemetrexed and 75 mg/m2 cisplatin) on day 1 and either 200 mg bid nintedanib or matched placebo on day 2.
There were no statistically significant nor clinically meaningful improvements in either overall survival or progression-free survival across the nintedanib arm.
“Unfortunately, the phase 3 results of LUME-Meso did not confirm that nintedanib in combination with pemetrexed/cisplatin prolongs patients’ lives … However, the trial reaffirms the need for solid confirmatory studies that are adequately sized, to challenge the standard of care in advanced malignant mesothelioma,” concluded the study’s lead researcher, Giorgio Scagliotti, MD, PhD, the University of Turin, Italy, in an official meeting press release.
Read more of Cancer Therapy Advisor‘s coverage of the IASLC 2018 meeting by visiting the conference page.
- International Association for the Study of Lung Cancer. LUME-Meso study shows nintedanib plus pemetrexed/cisplatin does not improve progression-free or overall survival in patients with malignant pleural mesothelioma of epithelioid subtype [press release]. Published September 25, 2018. Accessed September 25, 2018.