Boehringer Ingelheim, Germany., June 1, 2018 – Boehringer Ingelheim today announced results from an observational real-world study assessing the impact of dose adjustments of Giotrif®/Gilotrif® (afatinib) on safety and efficacy in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC). The study showed that dose adjustment with afatinib helped improve patient tolerability while maintaining treatment efficacy and reduced the frequency and intensity of drug reactions. These findings, which were consistent with clinical trials, were published online by the American Society of Clinical Oncology (ASCO) in advance of its 2018 annual conference.
“Clinical studies have already indicated that tolerability-guided dose adjustment may be possible with afatinib to manage known adverse drug reactions without impacting efficacy,” said study investigator Balazs Halmos, M.D., Director, Thoracic/Head and Neck Oncology, Professor of Clinical Medicine, Montefiore Einstein Center for Cancer Care, Bronx, NY. “Through this study, we better understand the real-world effect of tailoring the dose of afatinib when needed in patients with EGFR mutation-positive lung cancer.”
RealGiDo evaluated 228 EGFR mutation-positive lung cancer patients across 13 countries. Median time on treatment and time to progression was 18.7 months and 20.8 months, respectively, and was not impacted by reduced starting dose or dose modification. Overall adverse drug reaction incidence in patients starting on <30 mg was similar to those starting on ≥40 mg. The recommended dose of afatinib is 40 mg orally, once daily. Additionally, the study showed that there were no new safety signals, and grade 3 adverse drug events and serious adverse events occurred in 25% and 5% of participants, respectively.
“Results from the RealGiDo study which analyses the use of afatinib in a real-world setting ensure physicians have the latest information to help address the individual needs of their patients with advanced lung cancer,” said Dr Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim. “Real-world data have an important role to play as we build our understanding of how cancer medicines are used outside of a clinical trial environment.”
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About Afatinib
https://www.boehringer-ingelheim.com/sites/default/files/Documents/Afatinib_Backgrounder.pdf
About Boehringer Ingelheim in Oncology
Cancer takes away loved ones, time and untapped potential. At Boehringer Ingelheim we are providing new hope for patients by taking cancer on. We are collaborating with the oncology community to deliver scientific breakthroughs to transform the lives of patients. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.
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Footnotes
*Afatinib is approved in a number of markets, including the EU, Japan, China, Taiwan and Canada under the brand name Giotrif®, in the US under the brand name Gilotrif® and in India under the brand name Xovoltib® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.