Treatment for patients with metastatic non-small cell lung cancer (mNSCLC) with EGFR or HER2 exon 20 insertion mutations represents an important unmet need
The ZENITH20-5 trial (NCT03318939), presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, assessed the safety and tolerability of poziotinib in patients with metastatic non-small cell lung cancer (mNSCLC) with EGFR or HER2 exon 20 insertion mutations.
Patients were randomized to groups of 10, 12, 16 mg 1x/day or 6 and 8mg 2x/day of poziotinib. The endpoints were objective response rate (ORR) by RECIST 1.1, duration of response (DoR), progression-free survival (PFS), safety and tolerability.
ZENITH20-5 enrolled 122 patients who were randomized to the poziotinib arms 1x/day (26 patients for 16mg; 26 to 12mg; 37 to 10mg), poziotinib 2x/day (14 participants for 8mg; 19 to 6mg) and 62 patients are ongoing. The 10mg 1x/day dose cohort was terminated for suboptimal therapeutic effect. Demographic characteristics involved a majority of female (69%) and non-smokers (67%) patients.
Comparison of 1x/day versus 2x/day (16mg 1x/day versus 8mg 2x/day; 12mg 1x/day versus 6mg 2x/day) demonstrated relative reductions in dose interruptions of 38% and 52%, respectively. The time for the first interruptions was substantially shorter in the 2x/day dose regimen for the 16mg and 12mg arms (42% and 51%), respectively.
The rate of commonly expected treatment-related adverse events (skin rash, diarrhea, stomatitis) of grade 3 or higher was lower for the 2x/day dose (31% vs. 21% and 27% vs 16%, respectively) in cycle 1.
The researchers conclude that poziotinib demonstrated better tolerability and safety with dosing performed 2x/day. Additional efficacy data are needed to make a more definitive assertion on the efficacy of this dosage.
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