Affimed Announces 100% Objective Response Rate at Highest Dose in Phase 1-2 Study of Cord Blood-derived Natural Killer Cells Pre-complexed with Innate Cell Engager AFM13 for CD30-positive Lymphomas
100% objective response rate with a 42% complete response rate in 12 patients, according to investigator assessment, after the 1st of 2 planned cycles at the recommended phase 2 dose of 108 cord blood-derived natural killer (cbNK) cells/kg pre-complexed with AFM13
No cases of serious adverse events such as cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease were observed
Affimed to host virtual investor event on December 9th to discuss the results
HEIDELBERG, Germany, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimeds innate cell engager (ICE®) AFM13.
As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1x106, three patients with 1x107 and 12 patients with 1x108 AFM13-pre-complexed cbNK cells per kg body weight.
As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses (CR) and nine partial responses (PR). Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.
The patients enrolled in this study were all heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy, said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. We are encouraged by the response rates that we continue to observe in these difficult to treat patients. The data are in line with data presented at AACR earlier this year. We also continue to see a very good safety profile of the combination, which is important as many of these patients have been very heavily pretreated and cannot tolerate aggressive therapies. Combining our ICE® molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach.
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