Benzinga | Mar 10, 2021 08:26AM EST

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

Following the Independent Review Committee's assessment, Affimed NV (NASDAQ: AFMD) will 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.