- Affimed N.V. (NASDAQ: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.
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