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Iza-bren Hits PFS Primary Endpoint in EGFR-TKI-Resistant NSCLC Trial

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Iza-bren (BL-B01D1) has met its primary progression-free survival endpoint in the Phase III PANKU-Lung01 trial, which enrolled patients with advanced non-small cell lung cancer resistant to EGFR-TKIs. The data were selected as a late-breaking abstract for the 2026 ESMO Congress, with full results due on October 26. Historical platinum-based doublet chemotherapy in this setting achieved an objective response rate of about 30% and median PFS of 4 to 5 months; cited Phase II monotherapy data for iza-bren showed an ORR of 66.0% and median PFS of 12.5 months. Discussion has turned to where the drug might sit in later lines of therapy. Full Phase III efficacy and safety results, regulatory filings and positioning have yet to be seen.

Written by a model from the reports · updated 2 hours ago

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Oct 24
  1. mp.weixin.qq.comPick
    Iza-bren PANKU-Lung01 Hits PFS Primary Endpoint in EGFR-TKI-Resistant NSCLC; Su Chunxia Discusses Later-Line Positioning

    The Phase III PANKU-Lung01 trial of iza-bren (BL-B01D1) met its primary PFS endpoint in advanced NSCLC resistant to EGFR-TKIs and was selected as an LBA at the 2026 ESMO Congress, with data due on the 26th. Historical platinum-based doublet chemotherapy achieved an ORR of about 30% and median PFS of 4 to 5 months, while the cited Phase II monotherapy data for iza-bren showed an ORR of 66.0% and median PFS of 12.5 months.

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Heat now 9·Peak in the comparable set 10 (Oct 24 20:00)·Change over 24h in the comparable set –·Participants now 1

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CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org