Updated interim data from Affimed NV’s phase 1b dose-escalation study evaluating AFM13, the company’s lead NK cell engager candidate for relapsed/refractory (r/r) Hodgkin Lymphoma, were presented at the 23rd Congress of European Hematology Association (EHA) in Stockholm, Sweden.
"The high response rates in this study, in terms of both partial and complete responses, continue to compare favorably to the historical data of anti-PD-1 monotherapy, and would be expected to translate into meaningful progression-free and overall survival over time," said Dr Stephen Ansell, principal investigator of the study in a recent comment
. "Importantly, these data have shown that AFM13 can be safely administered in combination with pembrolizumab and has the potential to improve patient outcomes."
In a poster
presentation, Dr Eva Domingo of the Instituto Catalán de Oncología L’Hospitalet, Barcelona, Spain, discussed the phase 1b study
, which aims to establish a dosing regimen for the combination therapy in patients with R/R Hodgkin lymphoma; investigators are also evaluating the safety and tolerability of the combination in this population.
Enrollment was completed in February 2018 with a total of 30 patients recruited. Twenty-four of the 30 patients—6 from cohorts 1 and 2, and 18 from cohort 3 and the extension cohort—who had undergone at least 1 post-baseline disease assessment as of the data cut-off date were included in the interim analysis.
In the experimental arm of the study
, the AFM13 and pembrolizumab combination was administered in escalating doses intravenously (IV) for up to 25 weeks with pembrolizumab given as a fixed dose intravenously (IV) for up to 52 weeks.
The primary outcome measure for the study is the number of participants experiencing dose-limiting toxicity (DLT) during combination treatment in a time frame of up to 9 months. Secondary outcome measures include the number and frequency of adverse events and the objective response rate (ORR) in a time frame of 30 months.
Treatment with the highest dose of AFM13, 7.0 mg/kg, in 18 patients resulted in the best ORR of 89% (16/18 patients) and complete metabolic response rate (CmR) of 28% (5/18 patients). For these 18 patients, the ORR and CmR were found to compare favorably to those found in similar patient populations receiving anti-PD-1 monotherapy.
The investigators report that responders included 3 patients who were either primary refractory to or had relapsed during front-line therapy and were refractory to all subsequent lines of therapy. Generally, the AFM13 and pembrolizumab combination was well-tolerated. The most adverse events ranged from mild to moderate in severity and proved manageable with standard of care measures.
"We are very excited about the potential opportunities for AFM13 to benefit patients with CD30-positive malignancies," added Leila Alland, MD, Affimed's chief medical officer. "We are planning additional studies of AFM13 in patients with CD30-positive malignancies and are actively seeking guidance from experts on our development plans including potential accelerated approval paths."