NEW YORK – Ridgefield, Connecticut-based Boehringer Ingelheim on Tuesday announced pooled data from a collection of randomized clinical trials and real-world studies demonstrating that its TKI afatinib (Gilotrif) is efficacious across EGFR-mutated non-small cell lung cancer patients, regardless of their ethnicity.
Specifically, the analysis showed that both Asian and non-Asian patients with NSCLC whose tumors harbor G719X/L861Q/S768I non-resistant EGFR mutations responded to afatinib. The overall response rates among Asian and non-Asian patients were 66 percent and 59 percent, respectively. The median duration of response, moreover, was 14.7 months for Asian patients and 15.9 months for non-Asian patients.
When stratified by specific types of EGFR mutations, the response rates were 62 percent and 65 percent, respectively, for Asian and non-Asian patients with G719X mutations; 60 percent and 50 percent for patients with L861Q mutations; and 80 percent and 25 percent for patients with S768I mutations. The complete dataset will be presented during the International Association for the Study of Lung Cancer (IASLC)'s North America Conference on Lung Cancer this coming week.
The US Food and Drug Administration has approved afatinib for various lung cancer indications, including for the first-line treatment of metastatic NSCLC patients whose tumors have non-resistant EGFR mutations as detected by an FDA-approved test. Specifically, the FDA approved the therascreen EGFR RGQ PCR Kit as afatinib's companion diagnostic.
For patients with EGFR-mutated NSCLC who receive first-line treatment with afatinib but then develop subsequent resistance by way of acquired T790m mutations, recent real-world data suggests that patients may benefit from sequential treatment with osimertinib (AstraZeneca's Tagrisso).