Assertio (US:ASRT)2021-04-12 19:49Study Objective and Design - The ZENITH20 study is a Phase 2, open-label, multi-cohort, multi-center trial evaluating poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations[3] - Cohort 5 of ZENITH20 randomizes patients to different arms with varying doses of poziotinib: 10, 12, and 16 mg QD or 6 and 8 mg BID[3] Safety and Tolerability - Poziotinib demonstrates improved tolerability with BID dosing compared to QD dosing at both 8mg and 6mg BID[16] - The incidence of ≥Grade 3 related Adverse Events (AEs) was lower in the 8mg BID group (26%) compared to the 16mg QD group (50%)[8] - Drug interruption was less frequent in the 6mg BID group (50%) compared to the 16mg QD group (82%)[9] - Dose reduction was less frequent in the 10mg QD group (34%) compared to the 16mg QD group (59%)[9] Efficacy - Preliminary response data suggests improved anti-tumor activity with 8mg BID dosing compared to 10, 12, 16mg QD or 6mg BID[17] - The Overall Response Rate (ORR) in the 8mg BID group was 316% compared to 158% in the 16mg QD and 12mg QD groups, and 53% in the 6mg BID and 10mg QD groups[10] - The Disease Control Rate (DCR) in the 8mg BID group was 684% compared to 526% in the 16mg QD group[10]