AFM24 combined with atezolizumab has received a fast track designation from the FDA for treating advanced/metastatic non-small cell lung cancer without activating EGFR mutations.
A fast track designation has been granted to AFM24, an ICE, plus atezolizumab in advanced and/or metastatic NSCLC without activating EGFR mutations following progression on PD-1/PD-L1 therapy and platinum-based chemotherapy.1
Initial efficacy findings from the EGFR wild-type cohort of the phase 1/2a AFM24-102 trial support this regulatory decision. Of the 15 patients in the study with EGFR wild-type NSCLC, 4 had responses, including 1 patient with a confirmed complete response, 2 patients with confirmed partial responses (PRs), and 1 with an unconfirmed PR.
In the EGFR wild-type cohort, patients had received a median of 2 prior lines of therapy. All 15 patients experienced disease progression on PD-1/PD-L1 therapy.2
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“The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We’re observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment,” said Wolfgang Fischer, PhD, chief operating officer of Affimed N.V., in a press release.1 “The fast track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life-threatening disease who have exhausted all standard-of-care options, including chemotherapy and checkpoint inhibitors.”
More data from the EGFR wild-type cohort of the study are expected to be presented at the 2024 American Society of Clinical Oncology Annual Meeting.
The open-label, nonrandomized, multicenter, dose-escalation, and dose-expansion AFM24-102 trial is currently assessing the combination of AFM24 and atezolizumab in those with selected EGFR-expressing advanced solid malignancies. Patients must have had disease progression after receiving prior treatment.3
Enrollment was open to patients aged 18 years or older with histologically or cytologically confirmed advanced or metastatic, EGFR-positive cancers, and patients were required to have adequate organ function.
In phase 1 of the study, patients with evaluable or measurable disease per RECIST 1.1 criteria were enrolled, and in phase 2, measurable disease per RECIST 1.1 criteria is required. Among those in the EGFR wild-type NSCLC cohort of the study, eligibility criteria required patients to have disease progression after at least 1 prior line of therapy that included platinum-based doublet chemotherapy, and prior treatment with a PD-1 or PD-L1 inhibitor is required in combination with chemotherapy or before or after chemotherapy.
There are also cohorts of the trial specifically for patients with advanced, unresectable, or metastatic gastric/gastroesophageal junction cancer, advanced or metastatic hepatocellular carcinoma, and advanced or metastatic NSCLC harboring a targetable EGFR mutation.
In the dose-escalation portion of the study, investigators are using a 3+3 design and evaluating AFM24 when given at varying doses combined with 840 mg of atezolizumab given via intravenous (IV) infusion. The goal of this portion of the trial is to determine the maximum tolerated dose and recommended phase 2 dose of AFM24.
The dose-escalation portion of the study is giving the combination of AFM24 plus 840 mg of IV atezolizumab to patients. Investigators seek to examine the preliminary efficacy of the combination, as well as its safety.
Evaluating the incidence of dose-limiting toxicities is the primary end point for phase 1, and overall response rate is the primary end point for phase 2a. In addition, secondary end points being evaluated consist of pharmacokinetics, safety, and efficacy.
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