Citing Lack Of Durability, Affimed Scraps AFM13 Monotherapy Plans For NK Cell Combo

Affimed N.V. AFMD announced topline data from its phase 2 REDIRECT study of AFM13 monotherapy in patients with advanced-stage relapsed/refractory peripheral T cell lymphoma (r/r PTCL).
Primary efficacy measures include an objective response rate (ORR) of 32.4% and a complete response (CR) rate of 10.2%.
Other measures of efficacy included a median duration of response (DoR) of 2.3 months, median progression-free survival (PFS) of 3.5 months, and median overall survival (OS) of 13.8 months in patients who have undergone a mean of 2.7 prior lines of therapy.
Affimed does not intend to pursue accelerated approval for AFM13 monotherapy in PTCL and will focus investment on clinical development in the combination of AFM13 with Artiva's AB-101 NK cell product.
The company says that the combo therapy is more likely to deliver increased anti-tumor activity and a more durable clinical benefit.
As updated data released last month, the combination treatment continues to show a 100% ORR at the highest dose level and a further improvement in the CR rate from the previously reported 61.5% to 70.8%.
Price Action: AFMD shares closed 0.49% lower at $2.04 on Friday.