Affimed Reports Positive Early Efficacy and PFS Results for AFM24-102 Study in EGFR Wild-Type NSCLC at ASCO 2024

7 June 2024

In an ongoing clinical trial led by Affimed N.V., significant advancements have been made in treating patients with advanced EGFR wild-type non-small cell lung cancer (NSCLC). Affimed, a clinical-stage immuno-oncology company, is exploring the therapeutic potential of combining AFM24, its innate cell engager (ICE®), with atezolizumab, a checkpoint inhibitor from Roche. This study aims to provide new treatment avenues for patients who have already undergone platinum doublet chemotherapy and checkpoint inhibitors but continue to battle metastatic disease.

The AFM24-102 study, whose data was last updated on March 18, 2024, involves patients with EGFRwt NSCLC. Out of 17 patients who received the combination therapy, 15 were deemed response-evaluable. Among these, one patient experienced a complete response, while three others demonstrated partial responses. Furthermore, seven patients showed stable disease, contributing to an overall disease control rate of 73.3%. The median progression-free survival for participants was recorded at 5.9 months, with three of the four objective responses still ongoing.

The promising results from this trial are planned to be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, spanning May 31 to June 4, 2024. The full data will be showcased by Dr. Hye Ryun Kim from Yonsei University College of Medicine, during the Developmental Therapeutics - Immunotherapy poster session on June 1, 2024.

Patients in this study received AFM24 and atezolizumab at dosages typical for single-agent treatments. Despite the heavy pre-treatment these patients had undergone, the combination therapy was well tolerated. The most common side effects were mild to moderate infusion-related reactions and transient increases in liver enzymes.

Dr. Andreas Harstrick, Affimed's Chief Medical and acting Chief Executive Officer, expressed optimism about these findings. "We are very encouraged to see objective and lasting responses in patients who have failed multiple lines of therapy including platinum doublets and checkpoint inhibitors," he remarked. Dr. Harstrick emphasized the potential of combining AFM24 with atezolizumab to break through resistance seen in EGFR-expressing tumors, all without the need for chemotherapy. He reaffirmed the company's commitment to further clinical development, noting that the study is enrolling additional patients with both EGFRwt and EGFRmut NSCLC.

The EGFRwt cohort aims to enroll up to 40 patients, while the EGFRmut cohort will include up to 25 patients. These efforts highlight Affimed’s dedication to exploring and expanding the therapeutic implications of their innovative treatments.

AFM24, a bispecific tetravalent ICE®, is designed to engage the innate immune system by targeting CD16A on immune cells and the epidermal growth factor receptors (EGFR) prevalent in solid tumors. This mechanism facilitates the destruction of cancer cells through antibody-dependent cellular cytotoxicity and phagocytosis. AFM24's unique approach originates from Affimed’s proprietary ROCK® platform, which tailors molecules to harness innate immune cells effectively for tumor eradication.

Affimed N.V., headquartered in Mannheim, Germany, focuses on tapping into the innate immune system to combat a variety of hematologic and solid tumors. Their innovative ICE® molecules, developed through the ROCK® platform, show promise in both mono and combination therapies. The company continues to advance its pipeline, driven by a team of seasoned professionals with a unified vision to prevent cancer from compromising patients' lives.

Affimed will further discuss these findings and provide additional updates during a conference call/webcast on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. This event will offer insights into the initial clinical efficacy data from the NSCLC EGFR mutant cohort of the ongoing study.  

This development marks a significant step forward in the therapeutic landscape for NSCLC, offering hope for patients who have exhausted other treatment options.

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