Affimed N.V. ( AFMD ) shares are trading higher on Monday. On Saturday, the company announced longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the ongoing AFM24-102 study in non-small cell lung cancer (NSCLC).

As of the updated data cutoff on May 13, for the 17 EGFRwt patients previously reported, 15 patients were response-evaluable.

Four confirmed objective responses were seen: 1 complete response (CR) and three partial responses (PR).

In addition, eight patients achieved stable disease (SD), resulting in a disease control rate of 71%.

Median progression-free survival was 5.9 months, with a median follow-up of 7.4 months.

3 of 4 responses were ongoing for more than seven months.

All responders were resistant to checkpoint inhibitor treatment before the study, which supports the hypothesis that combining AFM24 with atezolizumab may provide an alternative strategy to overcome resistance to existing therapies.

As of May 21, 2024, 21 heavily pretreated EGFRmut patients had received the combination therapy, of which 13 were response-evaluable.

The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs, and six patients with stable disease (SD).

As of the data cutoff, all responses were ongoing. The data suggests that the combination of AFM24 and atezolizumab could be acting synergistically to improve efficacy outcomes.

AFM24 and atezolizumab combination therapy demonstrated a manageable safety profile. The most frequent side effects observed were mild to moderate infusion-related reactions and transient mild to moderate increase in liver enzymes.

The study’s EGFRwt NSCLC cohort will enroll up to 40 patients, and the EGFRmut NSCLC cohort will enroll up to 25 patients.

Recruitment in both cohorts is ongoing, and further updates are expected in H2 2024.

Price Action: AFMD shares are up 81.4% at $7.89 at last check Monday.