Dr Matasar on the Design of the OLYMPIA-3 Trial in DLBCL

Matthew Matasar, MD, chief, Division of Blood Disorders, Rutgers Cancer Institute; professor, medicine, Rutgers Robert Wood Johnson Medical School, discusses the design of the ongoing phase 3 OLYMPIA-3 trial (NCT06091865), which is investigating odronextamab (REGN1979) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; O-CHOP) in patients with treatment-naive intermediate- or high-risk diffuse large B-cell lymphoma (DLBCL), as well as the potential future implications of this research.

OLYMPIA-3 is composed of a safety run-in portion to evaluate the safety profile of O-CHOP and to clarify the optimal dose and dosing regimen in initial patient cohorts, Matasar says. Following the determination of the optimal treatment schedule and maximum tolerated dose, the global, randomized portion of the trial will commence, Matasar explains. Patients with newly diagnosed DLBCL with intermediate- or high-risk features will be randomly assigned 1:1 to receive either O-CHOP or R-CHOP (rituximab [Rituxan] plus CHOP]. Intravenous odronextamab will be administered weekly from cycle 1 day 8 until cycle 5 day 8, with step-up dosing during cycles 1 and 2, then every 2 weeks until the end of cycle 6. CHOP will be administered in 6 21-day cycles beginning on cycle 1 day 1.

The primary end points of part 1 of this trial are the incidence of dose-limiting toxicities and the incidence and severity of treatment-emergent adverse effects. Progression-free survival per independent central review will serve as the primary end point of part 2. Key secondary end points in part 2 will include event-free survival, complete response rate, and overall survival.

The trial is currently in the dose-optimization phase, and the phase 3 portion of the study will open soon, Matasar notes. This trial’s findings will be important for generating further data with odronextamab in DLBCL and may change the standard of care for this patient population in the future, Matasar concludes.