Heidelberg, Germany, November 19, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the Phase 1b study of AFM13, a CD30/CD16A innate cell engager (ICE®), in combination with KEYTRUDA was published in Blood, the renowned Journal of the American Society of Hematology. The results demonstrate promising signs of efficacy including an objective response rate (ORR) of 88% at the highest treatment dose, as well as a complete CR of 46%. As a monotherapy, KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.
The study assessed the safety and efficacy of AFM13 in combination with KEYTRUDA in 30 heavily pre-treated patients with R/R Hodgkin lymphoma. The safety profile for the combination was described as well-tolerated and similar to the known profiles for each agent alone. Most adverse events were low grade and remained manageable with standard-of-care therapies.
“Engagement of the innate immune system to kill tumors is novel. The studies of AFM13 and KEYTRUDA in Hodgkin lymphoma, as well as AFM13 in patients with T-cell lymphoma, present exciting approaches to controlling blood cancers that could significantly benefit patients,” said Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS), which supported Affimed’s clinical study of AFM13 through its Therapy Acceleration Program® (TAP), LLS’s strategic venture philanthropy funding initiative.
More details about the Phase 1b of AFM13 in combination with KEYTRUDA study can be found at www.clinicaltrials.gov using the identifier NCT02665650. The article published in Blood, Volume 136, Number 21 can be found here https://bit.ly/2KiL293.