REDIRECT is a Registration-directed Study of AFM13 in PTCL, after Positive Preplanned Interim Futility Analysis
Study will continue and combine cohorts of CD30 high and CD30 low expressing PTCL based on assessment from Independent Review Committee
Objective responses observed in heavily pretreated patients in both cohorts
Side effect profile similar to previously reported data
Conference call scheduled for March 10th at 8:30 a.m. EST
Heidelberg, Germany, March 10, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today its decision to continue enrollment in the REDIRECT trial, which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
The decision to continue the trial followed a preplanned interim futility analysis. The interim analysis was triggered following enrollment of 20 patients in both Cohort A (≥10% CD30) and Cohort B (>1% to <10% CD30). The futility boundaries were derived from response rates for previous therapies that have received accelerated approval in relapsed or refractory (R/R) PTCL. The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. 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 (IRRs) representing the main side effect. Following the introduction of mandatory premedication, IRRs were markedly reduced, resulting in fewer dose reductions and a trend towards better activity.
“We are very encouraged by the observed activity of AFM13 in this heavily pretreated patient population, where more than half of the patients had three or more lines of previous therapy. These data reinforce our strategy to broadly develop AFM13 across CD30-positive lymphomas both as monotherapy and in combination with other therapies,” said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. “Having successfully met the criteria for continuation, the trial will move forward by merging the CD30 high- and low-expressing PTCL cohorts for evaluation of the safety and efficacy of AFM13.”
“We are excited by this progress and by AFM13’s potential as monotherapy for patients with PTCL,” said Dr. Won Seog Kim, Principal Investigator of REDIRECT and Professor of Hematology and Oncology at the Samsung Medical Center, Sungkyunkwan University, Seoul, Korea. “PTCL is an aggressive and challenging cancer to treat in patients who relapse or do not respond favorably to current therapies, which often have high toxicity profiles, and new therapeutic approaches are needed.”
AFM13 is also being evaluated in combination with cord-blood derived natural killer cells in CD30-positive lymphomas at MD Anderson Cancer Center (MDACC). Initial data from this investigator sponsored study will be presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2021.