On December 11, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported updated data on its lead innate cell engager (ICE) acimtamig. Data from the investigator-initiated trial is being presented today at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study (Press release, Affimed, DEC 11, 2023, View Source [SID1234638441]). Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development.
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A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received CPIs and BV, and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an ORR of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of CRS, ICANS or GvHD of any grade. Mild to moderate infusion related reactions (IRRs) were seen in 7.7% of the acimtamig infusions.
Across all dose levels, median event free survival (EFS) was 8.8 months and median overall survival (OS) was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months – with 84% patients alive at 12 months. The median DoR was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months.
"When we conduct studies in a patient population that has failed their previous line of therapy, demonstrating even a modest response is encouraging. To see this magnitude of responses in terms of ORR (97%) and CR (78%) is remarkable and fuels our commitment to bring this therapy to more patients," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "Building on these results, we are well underway with our Phase 2 LuminICE-203 study. We have enrolled and dosed patients in the first two cohorts and we look forward to sharing data in the first half of 2024."
The Company will host a call today at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET to discuss the data presented at ASH (Free ASH Whitepaper) and provide a strategic update. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use the link: https://register.vevent.com/register/BIb2258d6c5f5a474cad74869a7b7b1bb5, and you will be provided with dial-in details and a pin number.
Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.
About the AFM13-104 Phase 1/2 Study
The University of Texas MD Anderson Cancer Center is studying acimtamig (AFM13) in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase that recruited 36 patients with r/r CD30 positive lymphomas, treated with the RP2D of 1×108 NK cells/kg followed by three weekly doses of 200 mg acimtamig monotherapy. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine (30 mg/m² per day) and cyclophosphamide (300 mg/m² per day) followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with acimtamig. Three weekly infusions of acimtamig (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET.
MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).
About Acimtamig
Acimtamig (AFM13) is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.