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Published on: November 12, 2019
A Phase II Study of Acimtamig (AFM13) in Patients with CD30-Positive, Relapsed, or Refractory Peripheral T-cell
Won Seog Kim1, Jake Shortt2,3, Pier Luigi Zinzani4,5
1Department of Hematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea.
Purpose:
Patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) generally have poor prognoses and limited treatment options. This study evaluated the efficacy of a novel CD30/CD16A bispecific innate cell engager, acimtamig (AFM13), in patients with R/R PTCL.
Patients And Methods:
Patients included those with CD30 expression in ≥1% of tumor cells and who were R/R following ≥1 prior line of systemic therapy. Acimtamig (200 mg) was administered once weekly in 8-week cycles. The primary endpoint was the overall response rate by fluorodeoxyglucose-PET per independent review committee; secondary and exploratory endpoints included duration of response, safety, progression-free survival, and overall survival.
Results:
The overall response rate in 108 patients was 32.4% [95% confidence interval (CI), 23.7, 42.1] with a complete response rate of 10.2% (95% CI, 5.2, 17.5); the median duration of response was 2.3 months (95% CI, 1.9, 6.5). Patients with R/R angioimmunoblastic T-cell lymphoma exhibited the greatest number of responses [53.3% (95% CI, 34.3, 71.7)]. Responses were independent of CD30 expression level, prior brentuximab vedotin treatment, or steroid premedication. Acimtamig exhibited a tolerable safety profile; the most common treatment-related adverse events were infusion-related reactions in 27 patients (25.0%) and neutropenia in 11 patients (10.2%). No cases of cytokine release syndrome or acimtamig-related deaths were reported. Despite exhibiting promising clinical activity and tolerable safety in a heavily pretreated PTCL population, the study did not meet the criteria for the primary endpoint.
Conclusions:
The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic NK cells.
Insights
Acimtamig showed promising activity in relapsed/refractory peripheral T-cell lymphoma, with a 32.4% overall response rate. Further investigation is warranted for this novel CD30/CD16A bispecific innate cell engager.
Area of Science:
- Oncology
- Immunotherapy
- Hematologic Malignancies
Background:
- Relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) has a poor prognosis.
- Limited effective treatment options exist for R/R PTCL patients.
Purpose of the Study:
- To evaluate the efficacy and safety of acimtamig (AFM13), a novel CD30/CD16A bispecific innate cell engager.
- To assess acimtamig in patients with R/R PTCL who have CD30 expression.
Main Methods:
- A phase study involving 108 patients with R/R PTCL and CD30 expression (≥1% tumor cells).
- Acimtamig (200 mg) was administered weekly for 8-week cycles.
- Primary endpoint: overall response rate (ORR) by PET scan; secondary endpoints: duration of response, safety, PFS, OS.
Main Results:
- ORR was 32.4% (95% CI, 23.7-42.1), with a complete response rate of 10.2%.
- Median duration of response was 2.3 months.
- Angioimmunoblastic T-cell lymphoma subset showed higher response rates (53.3%).
- Acimtamig demonstrated a tolerable safety profile, with infusion reactions and neutropenia as most common AEs. No cytokine release syndrome reported.
Conclusions:
- Acimtamig exhibited promising clinical activity and a tolerable safety profile in heavily pretreated R/R PTCL patients.
- Despite not meeting the primary endpoint, the observed efficacy warrants further investigation.
- Development of acimtamig continues, particularly in combination with allogeneic NK cells for CD30+ lymphomas.
