Saturday, September 27, 2014

Head-to-head Phase III Trial Demonstrates Superior Progression-Free Survival for Afatinib Compared to Erlotinib in Patients with Advanced Squamous Cell Carcinoma of the Lung

INGELHEIM, Germany - Saturday, September 27th 2014 [ME NewsWire]

    LUX-Lung 8 trial met its primary endpoint of improving progression-free survival in patients treated with afatinib* versus erlotinib after failure of first-line, platinum-based chemotherapy, reducing the risk of disease progression by 18%
    Overall rate of severe adverse events (≥ grade 3) was comparable between both therapies
    Limited treatment options currently exist for patients with squamous cell carcinoma of the lung, which represents approximately 30% of all non-small cell lung cancer cases with only about 15% of patients surviving for five years or longer

(BUSINESS WIRE)-- For Ex-US and Ex-UK Media Only

Phase III data from Boehringer Ingelheim’s LUX-Lung 8 trial, the first study to directly compare the efficacy of two different targeted agents in patients with advanced squamous cell carcinoma (SCC) of the lung, demonstrated superior progression-free survival (PFS: length of time before the tumour starts to progress) of afatinib compared to erlotinib. Afatinib, an irreversible ErbB Family Blocker, showed significant improvement across several measures of efficacy, in particular for the primary endpoint of PFS compared to erlotinib in patients after failure of first-line chemotherapy. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, with SCC representing approximately 30% of NSCLC cases. The results (abstract #1222O) are being presented today at the European Society for Medical Oncology (ESMO) 2014 Congress (September 26-30).

LUX-Lung 8 demonstrated that afatinib significantly reduced the risk of disease progression by 18% when compared to erlotinib, and delayed tumour growth (PFS by independent review: 2.4 vs. 1.9 months). In addition, afatinib showed an improvement in the secondary endpoint of disease control rate (DCR: the percentage of patients who achieved complete response, partial response or stable disease, 46% vs. 37%). The objective response rate (ORR: the percentage of patients who achieved a partial or complete response to therapy) was numerically higher with afatinib compared to erlotinib (5% vs. 3%).

Favourable trends were noted in delaying the worsening of lung cancer symptoms and global health status/quality of life. The proportion of patients reporting improvement in cough and global health status/quality of life, respectively, was significantly higher with afatinib versus erlotinib. Results of overall survival (OS: length of time patients live for), the key secondary endpoint, are not yet mature, and will therefore be assessed at a later stage in the trial and reported at a future medical congress.

Co-lead investigator Glen D. Goss, M.D., Director of Clinical and Translational Research, The Ottawa Hospital Cancer Center, University of Ottawa, Canada, commented: “The results of LUX-Lung 8 demonstrate the progression-free survival benefit for afatinib over erlotinib in advanced squamous cell carcinoma of the lung, a disease with poor prognosis for which there are currently limited treatment options.”

Co-lead investigator Professor Jean Charles Soria, Head Drug Development Department, Gustave Roussy Cancer Centre, Paris, France, added: “Further, the treatment also resulted in a favourable impact on patients’ overall health and quality of life, an important consideration for physicians treating patients with such advanced lung cancer. We are awaiting with interest the results of the overall survival data.”

The overall rate of severe (≥ grade 3) and serious adverse events was comparable between both therapies. Incidence of severe adverse events (≥ grade 3) was 50.2% in patients treated with afatinib compared to 49.1% with erlotinib. A higher incidence of ≥ grade 3 diarrhoea and stomatitis were observed in patients treated with afatinib compared to erlotinib (≥ grade 3 diarrhoea: 9% vs. 2%; stomatitis: 3% vs. 0%), while there was a higher incidence of ≥ grade 3 rash/acne observed with erlotinib compared to afatinib (9% vs. 6%). See abstract #1222O (A randomized, open-label, phase III trial of afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following first-line platinum-based chemotherapy: LUX-Lung 8 (LL8), 27.09.2014, 16.00 – 17:45, Madrid) for full details.

Afatinib’s mode of action differs from other EGFR TKIs such as erlotinib, which target EGFR (ErbB1) only, in that it provides sustained, selective and complete ErbB Family blockade. Afatinib’s novel mode of action may lead to a distinct therapeutic benefit.

Professor Gerd Stehle, Vice President, Medicine Therapeutic Area Oncology, Boehringer Ingelheim commented: “These data add to the growing body of clinical evidence supporting the efficacy and safety of afatinib in the treatment of distinct types of lung cancer. They demonstrate, for the first time, afatinib’s superiority compared to another targeted treatment in advanced squamous cell carcinoma of the lung. The results are an important step in advancing treatments for these patients.”

LUX-Lung 8 is the largest prospective trial to compare EGFR-targeting compounds in patients with advanced SCC of the lung. LUX-Lung 7, a second head-to-head trial evaluating afatinib versus gefitinib as a first-line treatment in EGFR mutation-positive non-small cell lung cancer patients, is currently ongoing.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

*Afatinib (GIOTRIF®/GILOTRIF®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. In this indication, afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF®. It is under regulatory review in other countries. Afatinib is not approved in other indications.

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