Affimed Announces Publication of Final Study Results of its Innate Cell Engager Candidate AFM13 in Combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in Blood
- The phase 1b study showed a complete response (CR) rate of 46% (objective response rate [ORR] of 88%) at the recommended dose level in patients with relapsed/refractory (R/R) Hodgkin lymphoma, whereas in a separate study MSD’s KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% as a monotherapy
- Investigators concluded that AFM13 in combination with KEYTRUDA for R/R Hodgkin lymphoma patients was well-tolerated with adverse events that were generally manageable
- Novel immunotherapy combination worthy of further investigation
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.
“We showed for the first time that the combination of an ICE with a PD-1 checkpoint inhibitor can be safely administered with manageable side effects,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “The high objective response rate and complete response rate seen in this proof-of-concept study of AFM13 combined with KEYTRUDA are very encouraging and indicate that the activation of innate immunity could improve upon current therapies.”
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.
AFM13 presents a novel approach of activating innate immunity through CD16A-directed tumor-cell killing by NK cells and macrophages. The phase 1b study supports the notion that in combination with an established therapy such as an immune checkpoint inhibitor, that releases the brakes on adaptive immune responses, the ICE AFM13 complements the PD-1 checkpoint inhibitor, thereby triggering both arms of the immune system against tumors.
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