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- 100% objective response rate and improvement in the rate of complete responses (CR) from 38% to 62% after a second cycle in 13 patients treated at the recommended phase 2 dose (RP2D)
- Patients enrolled were multi-refractory with a median of seven prior lines of treatment; all Hodgkin Lymphoma patients had failed brentuximab vedotin and PD-1 therapy in addition to failing multiple lines of chemotherapy
- Of the eight patients who achieved a CR at the RP2D, seven remain in CR at median follow-up of 6.5 months, including 2 patients who remain in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT)
- Treatment was well tolerated; no instances of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease were observed
- Data to be presented by Dr. Yago Nieto of The University of Texas MD Anderson Cancer Center, principal investigator of the study, as an oral presentation at AACR today, April 10, 1:00-3:00 pm CST during the Clinical Plenary Session
HEIDELBERG, Germany, April 10, 2022 (GLOBE NEWSWIRE) — Affimed NV (NASDAQ:AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today provided a data update from the ongoing study of the Company’s lead innate cell engager ( ICE®) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells. AFM13 is currently being investigated at The University of Texas MD Anderson Cancer Center in a phase 1/2 study in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas. The investigator-sponsored study is led by Yago Nieto, MD, Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The study shows a 100% objective response rate (ORR) and an improvement of complete response (CR) rate to 62% at the recommended phase 2 dose (RP2D) in 13 patients after 2 cycles of therapy. The results will be presented today during the Clinical Plenary Session on cellular immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2022 and will also be covered during an AACR press conference this morning.
“The data that we report today are highly encouraging. All patients on this trial were refractory to all available treatment options. Still the combination of AFM13 and precomplexed NK cells resulted in a 100% response rate and a 62% rate of complete responses. We are excited to see a deepening of responses from partial responses to complete responses with a second cycle and have amended the study to allow patients to receive additional cycles, which may further increase the efficacy,” said Dr Andreas Harstrick, Chief Medical Officer at Affimed. “To our knowledge, this is the highest response rate reported so far in Hodgkin Lymphoma patients with treatment refractory disease.”
As of the cut-off date, the study had enrolled 22 patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma having received a median of seven prior lines of therapy, of whom 19 were evaluable for response. Thirteen response-evaluable patients were Treated at the RP2D, including 12 patients with Hodgkin Lymphoma and one patient with non-Hodgkin Lymphoma. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single …
Full story available on Benzinga.com
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