Boehringer Ingelheim recently announced publication of the results from the LUX-Lung 8 trial (NCT01523587) in the journal The Lancet Oncology. The trial is a prospective Phase III head-to-head clinical study comparing two EGFR targeted treatments.
In LUX-Lung 8, Afatinib was evaluated in comparison to erlotinib, a recommended and approved drug for treatment of advanced squamous cell lung carcinoma (SCC) that progresses even following treatment with first-line platinum chemotherapy. Patients with lung SCC have a poor prognosis, with less than 5% five-years survival rates. Moreover, patients with lung SCC have limited treatment options.
Afatinib is not yet approved as treatment for patients with lung SCC, however, results from this trial demonstrated that patients treated with afatinib, an irreversible ErbB Family Blocker, had longer progression-free survival (PFS, the trial primary endpoint) and also achieved longer overall survival (OS, the trial key secondary endpoint) in comparison to patients treated with erlotinib.
Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented in a recent news release: “The ErbB family of receptors plays an important role in the development of squamous cell carcinoma of the lung, and is a valid therapeutic target for this type of cancer. The broader and irreversible ErbB blockade of afatinib may explain the superiority shown in LUX-Lung 8 over erlotinib, an EGFR inhibitor already approved in this setting. We are pleased with the publication of LUX-Lung 8 data in The Lancet Oncology and based on the improvement in overall survival with the use of afatinib, we are in the process of preparing regulatory submissions.”
LUX-Lung 8 previously reported results showing that the study’s primary endpoint was met, revealing that afatinib improved PFS in comparison with erlotinib. The results also showed that afatinib was able to extend the OS of patients to an average of 7.9 months in comparison to 6.8 months in the group of patients threated with erlotinib. This reduced the death risk by 19%.
Results from an updated analysis of the PFS, which was performed at the same time as the analysis of the OS, showed that that the group of patients that received treatment with afatinib achieved an average PFS of 2.6 months in comparison to 1.9 months for those patients treated with erlotinib.
Results from this updated analysis also showed that more patients treated with afatinib had an improvement in the levels of overall quality of life/well-being in comparison to patients treated with erlotinib. The results also revealed that the rate of severe adverse clinical events was comparable between the two trial groups with differences seen in the incidence of specific adverse clinical events.