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<p>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 (<i>n</i> = 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: <a href="https://clinicaltrials.gov/ct2/show/NCT03888105">NCT03888105</a>.</p>

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Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月17日

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  • Won Seog Kim,
  • Tae Min Kim,
  • Seok-Goo Cho,
  • Isidro Jarque,
  • Elżbieta Iskierka-Jażdżewska,
  • Li Mei Poon,
  • H. Miles Prince,
  • Huilai Zhang,
  • Junning Cao,
  • Mingzhi Zhang,
  • Benoît Tessoulin,
  • Sung Yong Oh,
  • Francesca Lim,
  • Cecilia Carpio,
  • Tran-Der Tan,
  • Sabarish Ayyappan,
  • Antonio Gutierrez,
  • Jingxian Cai,
  • Melanie Ufkin,
  • Saleem Shariff,
  • Jurriaan Brouwer-Visser,
  • Aafia Chaudhry,
  • Hesham Mohamed,
  • Srikanth Ambati,
  • Jan Walewski,
  • Hannah Rose,
  • Geoffrey Chong,
  • Vinod Ganju,
  • Michael Chu,
  • Mary-Margaret Keating,
  • Yuqin Song,
  • Jun Zhu,
  • Xiaoyan Ke,
  • Shuhua Yi,
  • Huilai Zhang,
  • Qingyuan Zhang,
  • Liqun Zou,
  • Mingzhi Zhang,
  • Dengju Li,
  • Wenbin Qian,
  • Ou Bai,
  • Li Gao,
  • Jie Jin,
  • Caixia Li,
  • Huiqiang Huang,
  • Zheng Wei,
  • Youhua Chen,
  • Pengcheng He,
  • Gandhi Laurent Damaj,
  • Kamal Bouabdballah,
  • Emmanuel Bachy,
  • Corinne Haioun,
  • Franck Morschhauser,
  • Sylvain Choquet,
  • Vincent Delwail,
  • Catherine Thieblemont,
  • Johannes Duell,
  • Thomas Weber,
  • Paul Graf La Rosee,
  • Holger Hebart,
  • Enrico Capochiani,
  • Vittorio Zilioli,
  • Francesca Rossi,
  • Stefano Luminari,
  • Pier Luigi Zinzani,
  • Laura Bagnato,
  • Gianluca Gaidano,
  • Marco Brociner,
  • Cristina Skert,
  • Monica Tani,
  • Roberta Battistini,
  • Leonardo Flenghi,
  • Ryusuke Yamamoto,
  • Kunihiro Tsukasaki,
  • Kenichi Ishizawa,
  • Tomomi Tobai,
  • Toshiki Uchida,
  • Yosuke Minami,
  • Nobuhiko Yamauchi,
  • Junichiro Yuda,
  • Masahiro Takeuchi,
  • Hirokazu Nagai,
  • Youko Suehiro,
  • Yoshiaki Ogawa,
  • Junya Kuroda,
  • Tatsuro Jo,
  • Hirohisa Nakamae,
  • Isao Yoshida,
  • Michal Taszner,
  • Ewa Lech-Maranda,
  • Wanda Knopinska-Posluszny,
  • Tomasz Wrobel,
  • Tadeusz Robak,
  • Wen Son Hsieh,
  • Shin Yeu Ong,
  • Hyeon-Seok Eom,
  • Yeung-Chul Mun,
  • Young Rok Do,
  • Jin Seok Kim,
  • Byung Soo Kim,
  • Jae-Cheol Jo,
  • Ana Jimenez-Ubieto,
  • Rafael Andreu,
  • Alejandro Martin,
  • Agustin Penedo Coello,
  • Raul Cordoba,
  • Aranzazu Alonso,
  • Laura Magnano,
  • Eva Gonzalez-Barca,
  • Sara Miqueleiz,
  • Tsai Yun Chen,
  • Su Peng Yeh,
  • Shang-Ju Wu,
  • Ming-Chung Wang,
  • David Cunningham,
  • Andrea Kuhnl,
  • David Tucker,
  • David Lewis,
  • Nagah Elmusharaf,
  • John Allan,
  • Thomas Jandl,
  • Sami Ibrahimi,
  • Deepa Jagadeesh,
  • Lori Leslie,
  • Parameswaran Venugopal,
  • Jon Arnason,
  • Jose C. Villasboas,
  • Rakhee Vaidya,
  • Don Stevens,
  • Farrukh Awan,
  • Andreas Klein,
  • Umar Farooq

摘要

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.