Phase III trial evaluated afatinib vs. pemetrexed/cisplatin therapy against late-stage disease.
Boehringer Ingelheim reported positive data from a Phase III trial evaluating afatinib as first-line therapy in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). The open-label LUX-Lung 3 study is comparing once-daily oral afatinib with pemetrexed/cisplatin chemotherapy in 345 patients with stage IIIb or IV disease. The results showed that in the overall patient population afatinib therapy was associated with a PFS of 11.1 months, compared with 6.9 months for patients treated using chemotherapy.
About 90% of patients in the study harbor the most common Del19 or L858R EGFR mutations. In this subset of patients afatinib therapy was associated with a median PFS of 13.6 months, compared with 6.9 months for patients in the chemotherapy arm.
Afatinib is an irreversible ERbB family blocker that targets EGFR (ErbB1), Her2 (ErbB2), and ErbB4. The drug is currently undergoing Phase III development as a treatment for NSCLC, head and neck cancer, and breast cancer. The LUX-Lung program includes eight studies evaluating afatinib in the treatment of advanced NSCLC.