Affimed Announces Positive AFM24/Atezolizumab Trial Results in NSCLC

In a recent announcement, Affimed N.V., a clinical-stage immuno-oncology company, shared promising clinical data from the AFM24-102 trial involving AFM24 and atezolizumab combination therapy for heavily pretreated non-small cell lung cancer (NSCLC) patients. This study showcases notable clinical activity and tolerability in patients with both EGFR wild-type (EGFRwt) and EGFR mutant (EGFRmut) NSCLC.

The trial's results revealed significant outcomes for NSCLC EGFRwt patients. Among 33 heavily pretreated individuals, the combination therapy achieved an overall response rate (ORR) of 21%, with six confirmed responses and one pending confirmation. The disease control rate (DCR) was 76%, with 48% experiencing tumor shrinkage. Furthermore, the preliminary median progression-free survival (PFS) was reported at 5.6 months, with 36% of patients still undergoing treatment.

In a parallel cohort of 17 NSCLC EGFRmut patients, the AFM24 and atezolizumab combination achieved a 24% ORR and a 71% DCR. Tumor shrinkage was observed in 41% of patients, with a median PFS of 5.6 months. Notably, five patients remained on treatment for over 10 months, indicating the combination's potential for long-term tumor control.

In both groups, the side effect profile was manageable, with no new safety concerns emerging. A common adverse event was infusion-related reactions, occurring in 54% of patients, predominantly during the first infusion and successfully managed. Elevated liver enzymes, known side effects of atezolizumab, were also reported in some patients but were controlled.

A post-hoc analysis of patients treated with 480 mg of AFM24 indicated that higher exposure to the drug correlated with improved response rates, PFS, and overall survival. This analysis informed Affimed's decision to use a higher dose of 720 mg weekly for future development, a dosage already shown to be safe in phase 1 trials.

Dr. Shawn Leland, Affimed's Chief Executive Officer, emphasized the potential of the AFM24/atezolizumab combination, noting that these findings pave the way for further advancements in treating heavily pretreated NSCLC patients. Affimed is committed to refining and progressing this promising therapy, focusing on those who could benefit the most.

The trial's patient population included individuals who had undergone a median of two prior lines of therapy, all of whom had received platinum-based combinations and checkpoint inhibitors. The AFM24 and atezolizumab combination therapy provided significant tumor control, especially in patients who had not previously responded to checkpoint inhibitors.

For the NSCLC EGFRmut cohort, all patients had prior treatment with EGFR-specific tyrosine kinase inhibitors, and the majority had received platinum-based chemotherapy. Despite this heavy pretreatment, the combination therapy showed promising efficacy.

Affimed's AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that targets the immune system to combat cancer by binding to CD16A on immune cells and epidermal growth factor receptors (EGFR) on tumors. This novel mechanism activates immune cells to kill cancer through antibody-dependent cellular cytotoxicity and phagocytosis.

The results of the AFM24-102 trial underscore the potential of Affimed's immunotherapy approach in NSCLC, offering a new avenue for patients who have exhausted conventional treatments. With ongoing research and development, Affimed aims to enhance the efficacy of AFM24 and explore its capabilities in providing effective cancer treatment.