Herbert Loong, Advisor at Greater Bay Area International Clinical Trial Institute, and Steering Committee Member at Lung Cancer Policy Network, shared a post on LinkedIn:
“Happy to share our new publication in JTOCRR!
ATORG003 phase2 trial tested a dose-titration strategy for dacomitinib in treatment-naïve advanced EGFR-mutated NSCLC across 5 Asian countries (118 patients). Instead of starting at 45mg (which caused high toxicity in ARCHER 1050), patients began at 30mg, with optional escalation to 45mg if well-tolerated.
Results: The trial met its primaryendpoint – 12-month PFS rate of 61.2%. Median PFS was 16.1 months, ORR 77%, and median TTF 19.3 months. Tolerability improved: 70% stayed on 30/45mg without dose reduction (vs just 34% in ARCHER 1050), and only 5% discontinued due to adverse events.
First prospective data on dacomitinib’s brain activity: in patients with CNS metastases, intracranial ORR was 54% and median intracranial PFS 17.6 months. 🔬 Resistance profiling showed high EGFR T790M rates (38% plasma, 52% tissue), supporting sequentialtreatment with later-generation TKIs.
Takeaway: Dose titration made dacomitinib more tolerable while preserving efficacy – a practical first-line option, especially where 3rd-gen TKIs aren’t accessible.
Whilst Pfizer has made decision to discontinue dacomitinib, this study nevertheless provided access to EGFR TKIs to some patients who otherwise would not have had access.”
Title: Dacomitinib with or without dose titration in treatment naïve advanced EGFR mutated NSCLC – primary analysis of the ATORG-003 phase 2 trial
Authors: Aaron C. Tan, Tae Min Kim, Siqin Zhou, Yueh Ni Lim, Gwo Fuang Ho, Lye Mun Tho, Thanyanan Baisamut, Naiyarat Prasongsook, Suee Lee, Sze Huey Tan, Dong-Wan Kim, Tony Mok, Daniel S.W. Tan, Herbert H. Loong
Read the Full Article.
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