Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study
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Nintedanib is a triple angiokinase inhibitor approved with docetaxel for adenocarcinoma non-small cell lung cancer after first-line chemotherapy (FLT). In the phase III LUME-Lung 1 study, overall survival (OS) was significantly longer with nintedanib/docetaxel than with placebo/docetaxel in all adenocarcinoma patients and those with time from start of FLT (TSFLT) <9 months.
This study sought to extend analyses from the LUME-Lung 1 study, specifically for adenocarcinoma patients, to explore the impact of clinically relevant characteristics on outcomes such as time to progression after FLT.
Patients and Methods
Exploratory analyses were conducted of the overall and European LUME-Lung 1 adenocarcinoma population according to age, prior therapy, and tumor dynamics. Analyses also used TSFLT and time from end of FLT (TEFLT).
Treatment with nintedanib/docetaxel significantly improved OS in European patients independently of age or prior therapy. Analyses of several patient subgroups showed improvements in median OS: TSFLT <6 months, 9.5 versus 7.5 months (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.55–0.98); chemorefractory to FLT, 9.1 versus 6.9 months (HR 0.72, 95% CI 0.52–0.99); progressive disease (PD) as best response to FLT, 9.8 versus 6.3 months (HR 0.62, 95% CI 0.41–0.94); TEFLT ≤6 months, 11.3 versus 8.2 months (HR 0.75, 95% CI 0.61–0.92); and TEFLT <3 months, 11.0 versus 8.0 months (HR 0.74, 95% CI 0.58–0.94).
Nintedanib/docetaxel demonstrated significant OS benefits in adenocarcinoma patients, which were more pronounced in patients with shorter TSFLT or TEFLT, or with PD as best response to FLT.
Analyses were conducted by Boehringer Ingelheim. The authors would like to thank the study investigators, study center staff, and all trial participants and their families.
Compliance with Ethical Standards
The studies on which this analysis was based, were sponsored by Boehringer Ingelheim. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Aurora O’Brate, PhD, of inVentiv Medical Communications, UK, during the preparation of this manuscript.
Conflicts of Interest
JB has received consulting fees/honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, and Roche. J-YD has received a research grant from Merck Serono for his institution and consulting fees/honorarium and payment for lectures/speakers bureaus from Amgen, AstraZeneca, Bayer, Roche, Sanofi, and Sirtex. AM has received consulting fees/honorarium (advisory board) from Boehringer Ingelheim. DFH has received consulting fees/honoraria from Boehringer Ingelheim, Eli Lilly, Hoffmann-la Roche, and Bristol-Myers Squibb. YS has received consulting fees/honoraria (advisory board), support for travel to a conference, and payment for lectures/speakers bureaus from Boehringer Ingelheim. SN has received payment for lectures/speakers bureaus from Eli Lilly, Merck Sharp & Dohme, Bristol-Myers Squibb, Roche, and AstraZeneca. JS is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. RK is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG and an applicant on a pending patent for nintedanib. MR has received consulting fees/honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis, and Pfizer. MG, IB, JvP, MK, and SO have no conflicts of interest to disclose.
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