Phase III trial shows afatinib offers clinical benefit to patients with EGFR mutation positive NSCLC

“Afatinib has a novel mode of action and data has shown that it offers a clinical benefit to patients with a specific type of lung cancer, which we are further investigating in the extensive LUX-Lung clinical trial programme”

Data from the LUX-Lung clinical trial programme, investigating afatinib in patients with advanced non-small cell lung cancer (NSCLC), have been published in the Journal of Clinical Oncology. These data include results from the pivotal LUX-Lung 3 Phase III registration trial which show that afatinib delays tumour growth and improves disease-related symptoms and quality of life compared to standard chemotherapy, when used to treat patients with EGFR mutation positive NSCLC.

Research has shown there are many different types of lung cancer requiring a unique treatment approach to improve patient outcomes. A distinct subtype of lung cancer is EGFR mutation positive NSCLC. The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients. Clinical trial data has shown afatinib could offer benefits to patients with this type of lung cancer.¹

"A diagnosis of lung cancer can be devastating for patients and their families. As oncologists our goal is to ensure the best possible outcomes for patients through tailored treatment approaches," said Professor James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan and lead investigator of the LUX-Lung 3 trial. "These positive results published in the Journal of Clinical Oncology represent an advance in individualised treatment for lung cancer and emphasise the benefits afatinib could offer to lung cancer patients with EGFR mutations."

Data published in the Journal of Clinical Oncology from the LUX-Lung clinical trial programme show the potential of afatinib to improve the lives of patients with lung cancer:

• Data from the LUX-Lung 3 trial demonstrate superiority of afatinib over chemotherapy considered best-in-class (pemetrexed/cisplatin) in EGFR-mutation positive advanced NSCLC patients.^2,3,4 Patients treated with afatinib lived for almost one year (progression-free survival (PFS) of 11.1 months) before their tumour started to grow again compared to just over half a year (PFS of 6.9 months) for those treated with chemotherapy.² Importantly, patients taking afatinib with the most common EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm. Adverse events (AEs) in LUX-Lung 3 were as expected with EGFR inhibition, consistent with previous studies, and were predictable, manageable and reversible. The most common adverse events associated with afatinib were diarrhea and skin-related side effects, which rarely led to discontinuation of treatment.²
• Additional data from the LUX-Lung 3 trial demonstrate patients taking afatinib also experienced an improvement in life-restricting lung cancer symptoms and a better quality of life (QoL) compared to those receiving standard chemotherapy treatment.³ Afatinib significantly delayed the time to deterioration for cough (hazard ratio [HR], 0.60;>3
• Data from the LUX-Lung 4 trial, a Japanese single-arm Phase II trial in NSCLC patients who have progressed after EGFR-tyrosine kinase inhibitor treatment, demonstrated afatinib^* treated patients experienced a median overall survival (OS) of just over a year and a half (19.0 months) and median PFS of 4.4 months.⁵ This highlights the efficacy of afatinib in this difficult-to-treat patient population. Adverse events were as expected with EGFR inhibition.⁵

"Afatinib has a novel mode of action and data has shown that it offers a clinical benefit to patients with a specific type of lung cancer, which we are further investigating in the extensive LUX-Lung clinical trial programme," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "We are delighted that the Journal of Clinical Oncology has chosen to publish data from this programme, which adds to the growing body of positive clinical evidence for afatinib."

The LUX-Lung clinical trial programme continues to investigate afatinib in advanced NSCLC in different settings and patient populations, in order to fully evaluate the potential of this treatment option. Based on this comprehensive programme, afatinib has been submitted to regulatory bodies worldwide for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. Afatinib is approved in the U.S. under the U.S. brand name GILOTRIF™, and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for afatinib.