Phase 3 Trial Update of Afatinib for Advanced non-Small Cell Lung Cancer

Boehringer Ingelheim announced results from its LUX-Lung 3 Phase 3 clinical trial of afatinib in patients with advanced non-small cell lung cancer (NSCLC). Patients taking afatinib as a first-line treatment lived for almost one year before their disease progressed (progression-free survival [PFS] of 11.1 months) vs. just over half a year (PFS of 6.9 months) for those on standard chemotherapy (pemetrexed/cisplatin).

Patients with EGFR mutations (del19 and L858R) lived for well over a year without progression (PFS of 13.6 months) vs. just over half a year (PFS of 6.9 months) for those in the comparator arm.

LUX-Lung 3 was a large, randomized, open-label, Phase 3 registration study comparing afatinib to pemetrexed and cisplatin as first-line treatment for in 345 patients with stage IIIb or IV NSCLC harboring an EGFR mutation. The study met the primary endpoint of progression-free survival and preliminary analysis showed that afatinib almost doubled the PFS time for patients with EGFR mutations.

Afatinib is an investigational oral, once-daily, irreversible ErbB family blocker that specifically inhibits EGFR (or ErbB1), HER2 (or ErbB2), and ErbB4, key receptors that play a role in the growth and spread of cancers.

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