Matthew Matasar, MD, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, discusses ongoing data from the phase 3 OLYMPIA-3 trial.

The study examines odronextamab (O) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) versus rituximab plus CHOP (R-CHOP) among patients with previously untreated diffuse large B-cell lymphoma (DLBCL) and intermediate- or high-risk features.

Ongoing data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Transcript:

Hi, I'm Dr. Matt Matasar from the Rutgers Cancer Institute. It's my pleasure to speak with you today about our trial in progress presentation from ASCO 2024 on the OLYMPIA-3 trial. By way of background, obviously, our job is a standard of care treatment for newly diagnosed diffuse large B-cell lymphoma. Nonetheless, outcomes remain suboptimal.

Odronextamab (ODRO) is one of a number of approved, or in evaluation, CD20 by CD3 bispecific antibodies. And ODRO, for short, was shown in the ELM-2 study to be both effective and well-tolerated in patients with previously heavily pretreated large cell lymphoma, with an overall response rate of 52% and a [complete response] (CR) of 32%.

Here, we're evaluating the incorporation of ODRO in addition to CHOP chemotherapy, called O-CHOP, eventually as compared to R-CHOP in previously untreated moderate or high-risk large cell lymphoma. OLYMPIA-3 is a 2-part, phase 3 randomized trial that will aim to enroll in total of 904 patients from approximately 200 sites globally. Part 1A is looking at safety, preliminary efficacy, biomarkers for the O-CHOP program at 2 different dose levels. We're then going to go into Part 1B, which will be a randomized exploration of the 2 O-CHOP regimens based on the ODRO dose level from 1A, which will [then] be used to inform the randomized phase 3 trial, which will be a 1-to-1 randomization of R-CHOP versus O-CHOP for International Prognostic Index (IPI)-2 plus large cell lymphoma.

Eligibility criteria are pretty straightforward. For the initial lead-in phases where we're doing dose exploration, it's going to be for previously untreated CD20 positive large cell lymphoma, as well as high-grade B cell lymphoma. Patients have to have an IPI of 2 or other high -risk features. In this lead-in phase, patients are going to receive 6 cycles of O-CHOP and then for the randomized phase, 1-to-1 of O-CHOP versus R-CHOP. Primary end points for Parts 1A and 1B are going to be dose-limiting toxicities and treatment emergent adverse events.

The primary end point for Part 2 is going to be [progression-free survival] PFS by independent central review, although we are going to be looking carefully as well at overall survival as a key secondary endpoint, in addition to others, CR rate, [event-free survival] EFS and the like. Additional secondary points are going to include [best overall response] BOR, duration of response, [patient-reported outcomes] PROs, safety and [pharmacokinetic study] PK as well. We're going to be using logical [measurable residual disease] MRD measurements as well to try to better understand the role of MRD in the post-treatment setting for following patients after completion of induction.

In conclusion, OLYMPIA-3 is going to provide important information on whether odronextamab plus R-CHOP can prolong progression-free survival, deepen response, or even improve overall survival as compared to R-CHOP chemoimmunotherapy in patients with previously untreated large cell lymphoma or high-grade lymphoma. Thanks for your interest.

Source:

Matasar M, Turgut B, Tessoulin B, et al. Phase 3 trial evaluating efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL; OLYMPIA-3). Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract TPS7086