Positive results from LUX-Lung 3 trial of Tomtovok (Boehringer) in NSCLC patients

LUX-Lung 3, the pivotal Phase III clinical trial investigating Tomtovok (afatinib), from Boehringer, in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor mutation (EGFR M+), met its primary endpoint of progression-free survival (PFS). LUX-Lung 3, which compares Tomtovok to pemetrexed/cisplatin, is the largest Phase III trial to date in first-line EGFR mutation-positive, advanced, metastatic NSCLC patients, and the first to use pemetrexed/cisplatin as a comparator in this population. Results showed that in the general study population, patients assigned to the Tomtovok arm had a PFS of 11.1 months versus 6.9 months for patients in the pemetrexed/cisplatin arm. Approximately 90 percent of patients in the study had the most common EGFR mutations (Del19 and L858R). In this subset, patients in the Tomtovok arm had a median PFS of 13.6 months, versus a median of 6.9 months for those patients in the chemotherapy arm. The most common drug-related adverse events observed in the Tomtovok treatment arm were diarrhea (95%), rash (62%) and paronychia (57%). The data is presented at the American Society of Clinical Oncology.