| Title: |
Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial |
| Authors: |
Kim, WS; Kim, TM; Cho, SG; Jarque, I; Iskierka-Jażdżewska, E; Poon, LM; Prince, HM; Zhang, H; Cao, J; Zhang, M; Tessoulin, B; Oh, SY; Lim, F; Carpio, C; Tan, TD; Ayyappan, S; Gutierrez, A; Cai, J; Ufkin, M; Shariff, S; Brouwer-Visser, J; Chaudhry, A; Mohamed, H; Ambati, S; Walewski, J; Farooq, U; Klein, A; Awan, F; Stevens, D; Vaidya, R; Villasboas, JC; Arnason, J; Venugopal, P; Leslie, L; Jagadeesh, D; Ibrahimi, S; Jandl, T; Allan, J; Elmusharaf, N; Lewis, D; Tucker, D; Kuhnl, A; Cunningham, D; Wang, MC; Wu, SJ; Yeh, SP; Chen, TY; Miqueleiz, S; Gonzalez-Barca, E; Magnano, L; Alonso, A; Cordoba, R; Coello, AP; Martin, A; Andreu, R; Jimenez-Ubieto, A; Jo, JC; Kim, BS; Kim, JS; Rok Do, Y; Mun, YC; Eom, HS; Ong, SY; Hsieh, WS; Robak, T; Wrobel, T; Knopinska-Posluszny, W; Lech-Maranda, E; Taszner, M; Yoshida, I; Nakamae, H; Jo, T; Kuroda, J; Ogawa, Y; Suehiro, Y; Nagai, H; Takeuchi, M; Yuda, J; Yamauchi, N; Minami, Y; Uchida, T; Tobai, T; Ishizawa, K; Tsukasaki, K; Yamamoto, R; Flenghi, L; Battistini, R; Tani, M; Skert, C; Brociner, M; Gaidano, G; Bagnato, L; Zinzani, PL; Luminari, S; Rossi, F; Zilioli, V; Capochiani, E; Hebart, H; La Rosee, PG; Weber, T |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2025 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
The phase 2, multicohort, ongoing ELM-2 study evaluates odronextamab, a CD20×CD3 bispecific antibody, in patients with relapsed/refractory (R/R) B cell non-Hodgkin lymphoma after ≥2 lines of therapy. Here primary analysis of the diffuse large B cell lymphoma (DLBCL) cohort is reported. Patients received intravenous odronextamab in 21-day cycles until progression or unacceptable toxicity, with cycle 1 step-up dosing to mitigate cytokine release syndrome (CRS) risk. The primary endpoint was objective response rate (ORR). Secondary endpoints included complete response (CR) rate, duration of response, progression-free survival (PFS) and overall survival. A total of 127 patients were enrolled. At the 29.9-month efficacy follow-up, the ORR was 52.0% and CR rate was 31.5%. Median durations of response and CR were 10.2 and 17.9 months, respectively. Undetectable minimal residual disease at cycle 4 day 15 was associated with PFS benefit. With a step-up of 0.7 to 4 to 20 mg (n = 60), CRS was the most common treatment-emergent adverse event (53.3% (grade ≥3, 1.7%)). No immune effector cell-associated neurotoxicity syndrome was reported. Infections were reported in 82/127 (64.6%) patients (grade ≥3, 38.6%; coronavirus disease 2019, 18.1% (grade ≥3, 12.6%)). In conclusion, odronextamab showed encouraging efficacy in heavily pretreated R/R DLBCL and generally manageable safety with supportive care. Clinical trial registration: NCT03888105 . |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
2662-1347 |
| Relation: |
https://hdl.handle.net/11343/356678 |
| Availability: |
https://hdl.handle.net/11343/356678 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 ; CC BY |
| Accession Number: |
edsbas.DA06607 |
| Database: |
BASE |