Affimed To Continue Enrollment In AFM13 Lymphoma Study After Positive Interim Data

Loading...
Loading...

Following the Independent Review Committee's assessment, Affimed NV (NASDAQ: AFMDwill continue enrollment in Phase 2 REDIRECT trial evaluating AFM13 as a monotherapy for relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).

  • The study will continue and combine cohorts of CD30 high and CD30 low expressing PTCL.
  • Preplanned interim futility analysis was conducted in 20 patients in Cohort A (more than 10% of CD30 expression) and Cohort B (CD30 expression between 1% to 10%). The analysis demonstrated that Cohort A's response rate achieved the predefined threshold for the continuation of the study.
  • The response rate in Cohort B was sufficiently comparable to allow the merging of both cohorts into a single cohort.
  • Evidence of anti-tumor response was observed in both cohorts with complete and partial responses.
  • The safety analysis was consistent with previously reported data from Affimed's Phase 1 trials of AFM13, with infusion-related reactions representing the main side effect.
  • Price Action: AFMD shares moved 14.3% higher at $6.25 in premarket trading on the last check Wednesday.
Posted In: BiotechNewsHealth CareSmall CapFDAGenerallymphoma
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...