Affimed (AFMD) Study Update summary

Study design and patient population

• AFM24-102 evaluated AFM24 plus atezolizumab in advanced NSCLC, enrolling both EGFR wild-type and EGFR mutant cohorts, with heavily pretreated patients.

• EGFRwt cohort included 43 patients (33 per protocol), median age 67–68, all previously treated with platinum-based chemotherapy and checkpoint inhibitors; 65% had prior taxane exposure.

• EGFRmut cohort included 28 patients (17 per protocol), median age 67, all had prior EGFR TKI therapy and most had platinum-based chemotherapy.

• Most patients were resistant to prior PD-1 therapy and had a median of two to three prior lines of treatment.

Safety and tolerability

• Combination therapy was well tolerated, with no new safety signals or unexpected toxicities; most common adverse events were infusion-related reactions and transient transaminase elevations.

• Infusion-related reactions occurred mainly during the first infusion and resolved fully; few Grade 3 events were reported.

• ALT and AST elevations, known side effects of atezolizumab, were reported in 21% and 16% of EGFRwt patients.

• Higher AFM24 exposure was not associated with increased toxicity or infusion reactions; high exposure group had fewer severe and serious adverse events.

• Safety profile was comparable between 480 mg and 720 mg doses, with initial infusions at higher dose split over two days to mitigate reactions.

Efficacy outcomes

• EGFRwt cohort achieved a disease control rate of 76%, tumor shrinkage in 48%, and ORR of 21% (1 CR, 6 PRs); 18% confirmed responses.

• Median PFS was 5.6 months in both EGFRwt and EGFRmut cohorts; taxane-naive patients had a median PFS of 7.4 months.

• EGFRmut cohort showed a disease control rate of 71%, tumor shrinkage in 41%, and ORR of 24% (1 CR, 3 PRs), with durable responses and some patients on therapy for over 10 months.

• 36% of EGFRwt and 29% of EGFRmut patients remained on treatment at data cut, with lasting remissions documented.