FDA Grants FTD to AFM13/AB-101 in Relapsed/Refractory Hodgkin Lymphoma

The FDA previously cleared an investigational new drug application for AFM13 plus AB-101 in May 2023, permitting developers to advance to phase 2 development in Hodgkin lymphoma.

The FDA has granted fast track designation to the investigational innate cell engager AFM13 plus AB-101 (AlloNK^®) as a treatment for patients with relapsed or refractory Hodgkin lymphoma, according to a press release from Affimed N.V.¹

Developers will evaluate AFM13 in combination with AB-101 in this patient population as part of the phase 2 LuminICE-203 study (NCT05883449), which will include an exploratory cohort of those with CD30-positive peripheral T-cell lymphoma (PTCL). The FDA previously cleared an investigational new drug application for AFM13 plus AB-101 in May 2023, permitting developers to advance to phase 2 development.²

Investigators intend for the LuminICE-203 study to build upon the findings from the phase 1/2 AFM13-104 trial (NCT04074746), in which patients with CD30-positive Hodgkin and non-Hodgkin lymphoma received treatment with AFM13 plus cord blood–derived natural killer (NK) cells. According to data that investigators previously read out at the 2022 American Society of Hematology (ASH) Annual Meeting, the overall response rate (ORR) was 94%, and the complete response (CR) rate was 71%.³ Additionally, the ORR and CR rates, respectively, were 97% and 77% among 31 patients with relapsed or refractory Hodgkin lymphoma. Overall, the experimental treatment was well tolerated among patients.

“Our clinical data of AFM13 in combination with allogeneic NK cells has shown outstanding efficacy and a well-managed safety profile in late-stage, muti-refractory patients with [relapsed/refractory] Hodgkin and Non-Hodgkin lymphoma,” Wolfgang Fischer, PhD, chief operating officer at Affimed, said in the press release.1 “The FDA fast track designation is a testament to the powerful potential our combination approach may deliver for these patients in high need, and we remain committed to working closely with the FDA to expedite development of this important therapy.”

The first-in-class AFM13 is designed to active the innate immune system to target CD30-positive hematologic tumors, thereby engaging and activating NK cells and macrophages to leverage the immune system.

Investigators will initiate the LuminICE-203 study with a safety run-in portion among patients with Hodgkin lymphoma across 4 dosing cohorts. Patients will receive 200 or 300 mg of AFM13 intravenously plus AB-101 intravenously at 2x10⁹ cells on days 1, 8, or 15, or 4x10⁹ cells on day 1 plus 2x10⁹ cells on days 8 and 15. Patients will also receive lymphodepleting chemotherapy with intravenous cyclophosphamide plus fludarabine and interleukin-2 subcutaneously.

The study’s primary end point is ORR per Lugano classification. Secondary end points include duration of response, CR rate, progression-free survival by independent radiology committee, overall survival, and treatment-emergent adverse effects (TEAEs) and serious AEs.

Patients 18 years and older with relapsed/refractory classical Hodgkin lymphoma or select subtypes of CD30-positive relapsed/refractory PTCL are eligible for enrollment on the trial. Those with classical Hodgkin lymphoma must have received at least 2 lines of therapy, including a line of chemotherapy, to enroll. Additionally, those with PTCL must have received at least 1 line of combination chemotherapy to enroll.

References

1. Affimed receives FDA fast track designation for AFM13 in combination with AlloNK® for the treatment of patients with relapsed or refractory Hodgkin lymphoma. News release. Affimed N.V. September 12, 2023. Accessed September 12, 2023. bit.ly/3PzGvOH
2. Affimed announces IND clearance for a phase 2 clinical trial investigating AFM13 and AB-101 combination therapy. News release. Affimed N.V. May 23, 2023. Accessed September 12, 2023. bit.ly/3IDn4Rj
3. Affimed provides updated clinical data from phase 1/2 study of AFM13 precomplexed with cord blood-derived NK cells at the ASH 2022 Annual Meeting. News release. Affimed N.V. December 10, 2022. Accessed September 12, 2023. bit.ly/3Lic8d2