Aptevo Therapeutics has begun dosing patients in a Phase ll clinical trial of monospecific antibody otlertuzumab to treat peripheral T-cell lymphoma (PTCL).
The open-label, proof-of-concept trial seeks to evaluate the safety and efficacy of otlertuzumab in combination with bendamustine in patients with relapsed or refractory PTCL.
The trial’s primary endpoint is response rate, evaluable by the 2017 International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017). It aims to enrol up to 24 patients.
Aptevo Therapeutics senior vice-president and chief medical officer Scott Stromatt said: “Clinical proof-of-concept data from a randomised Phase ll study demonstrated the efficacy and tolerability of otlertuzumab with bendamustine in relapsed chronic lymphocytic lymphoma (CLL).
"In this study, there was a significant increase in median progression-free survival, from approximately ten to 16 months in patients receiving the combination of otlertuzumab and bendamustine.
"We were intrigued by recent reports in the literature showing that CD37 appears to be overexpressed in various T-cell lymphomas, suggesting a potential role for otlertuzumab in the treatment of T-cell malignancies."
Aptevo further expects that successful completion of the Phase ll trial could open up a new market opportunity for otlertuzumab in treating T-cell malignancies.
Otlertuzumab is a monospecific antibody targeting CD37 and was developed on Aptevo’s ADAPTIR modular protein therapeutic platform.