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Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC at WCLC’26

Shots:

  • The global P-III (REZILIENT3) trial data assessed zipalertinib + CT vs CT in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations
  • After a 6-patient safety lead-in, 279 pts were randomized to zipalertinib (100mg, BID) + CT (n=140) or CT alone (n=139); as previously reported, the trial met its 1EP of improved PFS
  • After analysis of 122 PFS events, the trial showed improved mPFS (14.5 vs 8.5mos.), higher ORR (65% vs 40.3%) & longer mDOR (14.2 vs 9.9mos.), with consistent PFS benefit across subgroups, incl. pts with brain metastases; interim OS HR was 0.72 (30% maturity), with follow-up ongoing

Ref: Businesswire  |  Image: Taiho Oncology, Taiho Pharmaceutical & Cullinan |  Press Release

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