Yu HA, et al. – Researchers introduced phase 2 study of intermittent pulse dacomitinib in patients with advanced non–small cell lung cancers. This study found intermittent pulsatile dacomitinib safe and relatively well tolerated. However, recommend regimen was not effective in patients that harbor epidermal growth factor receptor (EGFR) T790M or in unselected patients with non–small cell lung cancer.

Methods

• Safety, pharmacokinetics and efficacy of intermittent pulsatile dacomitinib in both molecularly unselected patients and patients with lung cancers harboring EGFR T790M (Clinical Trial Registration Number NCT01858389), were assessed.

Results

• As per observations, thirty-eight patients were treated on study with pulse dacomitinib.
• Of these, sixteen with EGFR T790M in Cohort A and 22 who were not molecularly selected in Cohort B.
• Results revealed a partial response to study therapy in one patient out of 16 patients in Cohort A (ORR 6.3%, 95% CI 0.2-30.2%).
• In Cohort A, the median progression-free survival (PFS) was 2.3 months, and median PFS in Cohort B was 1.6 months.
• With the most frequent treatment-related toxicities occurring in >20% of patients being diarrhea, rash, stomatitis, nausea, dry skin, paronychia, fatigue, and decreased appetite, the adverse event profile was similar to standard daily dose dacomitinib.