ASCO: Affimed pivots to cancer combo after failing to meet monotherapy study continuation criteria

Affimed is rethinking development of its bispecific innate cell engager after getting a look at phase 1/2a monotherapy data. The biotech saw two partial responses in 15 patients, resulting in data that fell short of the continuation criteria but offered enough encouragement for it to plot more combination work.

The clinical trial tested AFM24, a candidate that is designed to bind to EGFR on tumor cells and another receptor on innate immune cells to orchestrate anti-cancer immune attacks. In the latest update from the open-label trial, which was shared at the American Society of Clinical Oncology annual meeting, the biotech presented data from the EGFR mutant non-small cell lung cancer (NSCLC) cohort.

Affimed enrolled 15 patients who had received a median of two prior lines of therapy in the cohort. Two patients had confirmed partial responses and a further five had stable disease, resulting in a response rate of 13% and disease control rate of 47%. The patients with stable disease took at least 3.5 months to progress. One patient had ongoing stable disease for more than eight months.

Based on the results, which fell short of the “formal continuation criteria for the cohort,” Affimed plans to stop enrolling patients in its AFM24 monotherapy clinical trial and focus on an ongoing combination study. The combination trial is testing the effect of adding AFM24 to Roche’s PD-L1 checkpoint inhibitor Tecentriq.

When the Tecentriq trial began in 2021, Affimed identified NSCLC as one of several EGFR-expressing cancers it planned to study. The focus on NSCLC is increasing under the revised strategy, with Affimed adding a new cohort of lung cancer patients to the combination trial. The combination trial is testing the idea that coactivation of innate and adaptive immune systems will improve outcomes. 

The Tecentriq study is currently one of two AFM24 combination trials but will soon be Affimed’s sole focus for the candidate. The second combination trial is testing AFM24 with NKGen Biotech’s autologous NK cell product in the belief the cell therapy could enhance the activity of Affimed’s candidate in tumors with unfavorable immune status. 

Affimed and NKGen have “mutually decided” to stop the study. The U-turn, which comes ahead of the release of initial data, follows the failure of another Affimed candidate, AFM13, to improve outcomes in lymphoma. Affimed responded to that setback by laying off 25% of its staff and focusing development of AFM13 on a NK cell combination trial.

Regarding AFM24, Affimed said it “will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product which the company expects to be better suited for combination with AFM24 in a highly advanced patient population.”