Early data demonstrated high tolerability and efficacy in the treatment of CD30-positive lymphomas with an innate cell engager (ICE) complexed with activated and expanded natural killer (NK) cells, according to results of a phase 1/2 trial presented at the AACR Annual Meeting 2022.

AFM13 was developed to address the need of patients with CD30-positive lymphomas who are relapse or are refractory to standard therapies. “If these treatments fail, these patients’ tumors become extremely resistant to killing, and patients are left with very few effective therapeutic options,” Yago Nieto, MD, PhD, of The University of Texas MD Anderson Cancer Center, and lead author of the study, said in a press release.2

AFM13 alone has shown preliminary efficacy in previous studies; however, preclinical studies suggest that linking it to cord blood-derived activated NK cells was more effective. The aim of this study was to evaluate the tolerability and activity of AFM13 complexed by activated allogeneic NK cells among patients with CD30-positive lymphoma.


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In the ongoing single-center, phase 1/2 trial, 19 patients with relapsed/refractory CD30-positive lymphoma have been treated with 2 cycles of fludarabine and cyclophosphamide, followed by AFM13 complexed with activated NK cells and 3 weekly infusions of AFM13. The cord blood used to derive the NK cells was selected without HLA matching.

The response rate was 89%, which included 8 complete responses. All patients who were treated with the recommended phase 2 dose level responded to treatment. The 6-month progression-free survival and overall survival were 58% and 79%, respectively.

The treatment was well tolerated, with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft vs host disease. Infusion reactions were uncommon, occurring in 5% of infusions with AFM13 alone and no cases in AFM13 complexed with NK cells.

Dr Nieto concluded that “our preliminary results indicate excellent tolerability and high activity and warrant further investigation of this approach.”

Disclosures: The study was funded by Affimed Therapeutics. One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies.

Reference

  1. Nieto Y, Banerjee P, Kaur I, et al. Innate cell engager (ICE®) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma. Presented at AACR 2022; April 8-13, 2022. Abstract CT003.
  2. Natural killer cells complexed with a bispecific antibody may provide new treatment option for patients with advanced lymphoma. News release. AACR. April 10, 2022. Accessed April 13, 2022. https://www.aacr.org/about-the-aacr/newsroom/news-releases/natural-killer-cells-complexed-with-a-bispecific-antibody-may-provide-new-treatment-option-for-patients-with-advanced-lymphoma/

This article originally appeared on Hematology Advisor