Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma

November 19, 2021 Auto Bot Antengene, approval, IND, NMPA, non-Hodgkin lymphoma, P-I/II, regulatory 0

Shots:

  • The NMPA has approved a P-I/II SWATCH dose-escalation & dose-expansion study that evaluates the safety, tolerability, and preliminary efficacy of selinexor in combination with the R2 regimen of lenalidomide + rituximab for rrDLBCL and rriNHL who are not eligible for HDC or ASCT. The study was conducted at 10 centers across China
  • The 1EPs of the study are the MTD and RP2D as determined by the DLT observed in the dose-escalation phase along with other key safety measures. The 2EPs include ORR, PFS & DoR of the SR2 regimen as assessed acc. to the Lugano 2014 criteria (Cheson, 2014) for the assessment of lymphoma
  • Selinexor has already received the US FDA’s approval for the treatment of rrDLBC

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