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<p>Persons with diffuse large B cell lymphoma (DLBCL) refractory or in first progression/relapsed (R/R) after chimeric antigen receptor T (CAR-T) cell therapy exhibit dramatic outcomes. We enrolled such persons in a phase 2 single-arm, nonblinded trial (<a href="https://clinicaltrials.gov/study/NCT04703686">NCT04703686</a>) to evaluate the efficacy and safety of glofitamab, a CD20–CD3 T cell-engaging bispecific antibody, using a short ramp-up regimen to reach full dose within 1 week. A total of 46 participants received at least one glofitamab infusion following obinutuzumab (anti-CD20 monoclonal antibody) pretreatment. The primary endpoint was overall survival (OS). Secondary endpoints included independent-assessed best overall metabolic response rate (OMRR) and complete metabolic response rate (CMRR), progression-free survival (PFS), duration of response, safety and tolerability and health-related quality of life. After a median follow-up of 15.3 months (95% confidence interval (CI), 10.1–17.7), the primary endpoint was met, achieving a median OS of 14.7 months (90% CI, 8.8–not reached). The best OMRR was 76.1%. The best CMRR was 45.7%. The median PFS was 3.8 months (95% CI, 2.4–19.6). Despite the shortened setup dosing, no excess cytokine release syndrome or neurotoxicity events were observed (grade ≥ 3, 0% for both). In conclusion, glofitamab improved OS in participants with R/R DLBCL after CAR-T cell therapy, with a favorable safety profile.</p>

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Glofitamab in refractory or relapsed diffuse large B cell lymphoma after failing CAR-T cell therapy: a phase 2 LYSA study

  • 期刊论文

  • 发表日期：

    2025年4月3日

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  • Guillaume Cartron,
  • Roch Houot,
  • Yassine Al Tabaa,
  • Fabien Le Bras,
  • Loïc Ysebaert,
  • Sylvain Choquet,
  • Fabrice Jardin,
  • Jacques-Olivier Bay,
  • François-Xavier Gros,
  • Franck Morschhauser,
  • Olivier Casasnovas,
  • Thomas Gastinne,
  • Catherine Thieblemont,
  • Magalie Joris,
  • Laure Ricard,
  • Caroline Regny,
  • Laurianne Drieu La Rochelle,
  • Pierre Feugier,
  • Ambroise Marcais,
  • Samuel Griolet,
  • Karin Tarte,
  • Camille Laurent,
  • Pierre Sesques

摘要

Persons with diffuse large B cell lymphoma (DLBCL) refractory or in first progression/relapsed (R/R) after chimeric antigen receptor T (CAR-T) cell therapy exhibit dramatic outcomes. We enrolled such persons in a phase 2 single-arm, nonblinded trial (NCT04703686) to evaluate the efficacy and safety of glofitamab, a CD20–CD3 T cell-engaging bispecific antibody, using a short ramp-up regimen to reach full dose within 1 week. A total of 46 participants received at least one glofitamab infusion following obinutuzumab (anti-CD20 monoclonal antibody) pretreatment. The primary endpoint was overall survival (OS). Secondary endpoints included independent-assessed best overall metabolic response rate (OMRR) and complete metabolic response rate (CMRR), progression-free survival (PFS), duration of response, safety and tolerability and health-related quality of life. After a median follow-up of 15.3 months (95% confidence interval (CI), 10.1–17.7), the primary endpoint was met, achieving a median OS of 14.7 months (90% CI, 8.8–not reached). The best OMRR was 76.1%. The best CMRR was 45.7%. The median PFS was 3.8 months (95% CI, 2.4–19.6). Despite the shortened setup dosing, no excess cytokine release syndrome or neurotoxicity events were observed (grade ≥ 3, 0% for both). In conclusion, glofitamab improved OS in participants with R/R DLBCL after CAR-T cell therapy, with a favorable safety profile.