On June 1, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the on-going AFM24-102 study in NSCLC (Press release, Affimed, JUN 1, 2024, https://www.affimed.com/affimed-provides-follow-up-data-of-afm24-plus-atezolizumab-showing-durable-responses-in-heavily-pretreated-nsclc-egfr-wild-type-patients-and-positive-initial-data-from-the-nsclc-egfr-mutant-cohort/ [SID1234643937]).
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As of the updated data cutoff on May 13, 2024 for the 17 EGFRwt patients previously reported on, 15 patients were response-evaluable. Four confirmed objective responses were seen: 1 complete response (CR) and 3 partial responses (PR). In addition, 8 patients achieved stable disease (SD), resulting in a disease control rate of 71%. Median progression-free survival was 5.9 months with median follow-up of 7.4 months. Importantly 3 of 4 responses were ongoing for more than 7 months. All responders were resistant to checkpoint inhibitor treatment prior to 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 (median of 3 prior therapies) 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 6 patients with SD. As of the data cut-off, all responses were on-going. EGFRmut NSCLC is considered an immunogenically weak subtype where single-agent therapy with immune checkpoint inhibitors have exhibited poor response rates. 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. Side effects were consistent with the known safety profiles of these agents. The most frequent side effects observed were mild to moderate infusion related reactions and transient mild to moderate increase in liver enzymes.
"The efficacy of the combination of AFM24 and atezolizumab in these heavily pretreated NSCLC patients is encouraging and supports our hypothesis of a synergistic activity of AFM24 with PD-1/PD-L1 blockade. We believe the durability of the responses in EGFRwt tumors is remarkable and is unlikely driven by PD-1/PD-L1 blockade alone, as all patients with responses had documented progression on their previous PD-1/PD-L1 therapy. In addition, median PFS of atezolizumab, even in checkpoint naïve patients, is only 2.8 months," said Dr. Andreas Harstrick, Chief Medical and acting Chief Executive Officer of Affimed. "This growing body of evidence reinforces our belief that AFM24 in combination with check point targeting can address pressing unmet medical needs in refractory NSCLC patients."
The EGFRwt NSCLC cohort of the study 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.
Conference Call and Webcast Information
Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. Dr. Harstrick and Dr. Hye Ryun Kim, Professor at Yonsei University College of Medicine, Seoul, Korea, will review the latest clinical findings and address questions.
The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:
https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.
About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.