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Reported Sunday, Taiho And Cullinan's Zipalertinib Shows 40% ORR In Platinum-Treated EGFR ex20ins NSCLC, REZILIENT1 Results Published In JCO

Benzinga·06/02/2025 07:31:36
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Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include:

  • Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab.
  • The confirmed objective response rate (ORR) was 35.2% overall, and median duration of response (mDOR) and progression-free survival were 8.8 months and 9.4 months, respectively.
  • In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months.
  • The safety profile of zipalertinib was manageable and consistent with previously reported data.¹
  • In exploratory subgroup analyses:
    • Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months.
    • Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months